The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial

Ali Abbas Ibrahim; Abeer Abdulhadi Rashid

doi:10.12688/f1000research.142587.1

Home Browse The assessment of educational and supportive care to the infertile...

ALL Metrics

-

Views

-

Downloads

Get PDF

Get XML

Export

▬

✚

Research Article

Clinical trial

The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial

[version 1; peer review: 1 approved with reservations, 1 not approved]

Ali Abbas Ibrahim ¹, Abeer Abdulhadi Rashid¹

PUBLISHED 14 Dec 2023

Author details Author details

¹ Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, 10081, Iraq

Ali Abbas Ibrahim
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Software, Visualization, Writing – Original Draft Preparation

Abeer Abdulhadi Rashid
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background

Infertility affects approximately 10-15% of married individuals, and may trigger various emotional reactions. Females undergoing in vitro fertilization (IVF) are more susceptible to experiencing depression. This study aims to assess the influence of pharmacist counseling on quality of life, depression scores, and pregnancy rates among infertile females undergoing IVF treatment.

Method

The research examined women who visited the infertility clinic at Kamal Al-Samaraie Hospital in Baghdad, Iraq to achieve pregnancy. These individuals were separated into a control group and an intervention group. The intervention group received an educational program consisting of five visits, while the control group got a conventional hospital procedure. The present research evaluated the quality of life-related to fertility using the FertiQoL (Fertility Quality of Life) questionnaire. It examined the participants’ depression levels using the CES-D (Center for Epidemiologic Studies Depression) scale. These assessments were conducted at the commencement and conclusion of the in vitro fertilization (IVF) cycle.

Results

The present research included 150 women diagnosed with infertility, whose average age was 30.32 ± 5.64 years. The participants had a mean body mass index (BMI) of 27.12 ± 3.57. No statistically significant difference was seen in the FertiQoL evaluation scores between the control and intervention groups at the beginning of the study. The FertiQoL, assessed at the end of the trial, exhibited a statistically significant increase in the interventional group, with a P-value of 0.025. The prevalence of Depression risk patients decreased from 83% to 69%, and the interventional group exhibited a substantially greater proportion of favorable pregnancy outcomes (48%) compared to the control group (29.3%).

Conclusion

Infertile women who undergo IVF operations have higher rates of depression. Depression may be reduced, and quality of life improved with education and supportive counseling. Pregnancy rates rise as a result of clinical pharmacist counseling.

Trial registration

This study was registered on Clinical Trials.gov (NCT06022640).

Keywords

In Vitro Fertilization, Depression, FertiQoL, Supportive care, Clinical Pharmacist.

Corresponding author: Ali Abbas Ibrahim

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Abbas Ibrahim A and Abdulhadi Rashid A. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Abbas Ibrahim A and Abdulhadi Rashid A. The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1592 (https://doi.org/10.12688/f1000research.142587.1) First published: 14 Dec 2023, 12:1592 (https://doi.org/10.12688/f1000research.142587.1) Latest published: 14 Dec 2023, 12:1592 (https://doi.org/10.12688/f1000research.142587.1)

Introduction

Infertility impacts around 10-15% of married individuals, including males and females, and can result in a range of emotional responses such as anxiety, distress, pain, and disappointment.¹ This significant life event has the potential to impact several dimensions of a couple’s existence.² Preconception counseling is an essential need for the initiation of infertility therapy, as it encompasses a comprehensive assessment of several aspects, including medical, social, genetic, environmental, and occupational factors, which have an impact on both fertility and the overall well-being throughout pregnancy.³ Depression is a prevalent concern among women experiencing infertility, and pharmacists assume a pivotal role in the provision of treatment for those affected by depression.⁴^,⁵

The underlying cause of female infertility remains unclear; however, a significant proportion of cases (81%) may be attributed to ovulatory problems, endometriosis, pelvic adhesions, tubal obstruction, other tubal abnormalities, and hyperprolactinemia.⁶^,⁷ The decline in fertility is influenced by advancing age, and the incidence of infertility due to age increases as the reproductive lifespan diminishes. Infertility treatment aims to address remediable factors and overcome refractory ones.⁸^,⁹ The fundamental concepts of care for couples experiencing infertility include the identification and assessment of the underlying causes, as well as the subsequent implementation of appropriate treatment strategies.¹⁰ Additionally, recommendations may be made about behavioral modifications to enhance fertility, such as smoking cessation and minimizing exposure to potentially detrimental drugs.¹¹

Assisted reproductive technology (ART) is a medical intervention to address infertility, including therapeutic approaches that include ova and sperm. In assisted reproductive technology (ART), in vitro fertilization (IVF) is usually considered the most productive approach.¹² in vitro fertilization (IVF) is widely recognized as a very effective treatment for infertility, yet it sometimes requires numerous rounds of egg retrieval and embryo transfer.¹³ This treatment has shown efficacy in addressing unexplained infertility and conditions such as blocked or damaged fallopian tubes, hereditary abnormalities, uterine fibroids in women, ovulation difficulties, early ovarian failure, and cases where ovaries have been surgically removed.¹⁴

The process of IVF entails ovarian stimulation, which encompasses the administration of fertility medications to induce the development of eggs and control the operation of ovulation.¹⁵ Emotional alterations often occur among individuals undergoing in vitro fertilization (IVF), particularly those with a history of mental illness, experienced miscarriage, faced a prolonged period of infertility or received a conclusive medical diagnosis.¹⁶ The stress levels of IVF patients tend to rise as the intensity and duration of treatment grow, resulting in higher stress levels compared to women in the early stages of their infertility examination.¹⁷

The experience of infertility and the administration of corresponding drugs may elicit significant psychological distress among patients, particularly those who have undergone several in vitro fertilization rounds without achieving successful outcomes.¹⁸ Patients may lack familiarity with self-injecting gonadotropins, using hormone supplements, and adhering to other essential therapies required for ovulation induction cycles.¹⁹ Research indicates a negative association between depression and in vitro fertilization (IVF) conception rates. However, the specific influence of depression on emotional discomfort remains unknown.²⁰

Grief reactions are often reported in couples who are facing infertility. However, these usual grief reactions may develop into pathological grieving, characterized by prominent melancholy symptoms.²¹ Infertility-related depression in women varies between 10% and 25%, with women exhibiting significant depressive symptoms at two to three times greater rates than males.²²^,²³ The presence of depression has been shown to have adverse effects on several aspects of therapy, follow-up, and future perspective, as well as the strength and longevity of the relationship between the afflicted pair.²⁴

Pharmacists are crucial in providing education and supportive care for individuals suffering from depression.²⁵ They provide valuable guidance, suggestions, and counseling about drugs while monitoring patients for drug-related issues and evaluating patient adherence to prescribed treatments.²⁶ Pharmacists’ professional role includes pharmaceutical care concepts, transitioning them from their conventional role as mere dispensers of medications to being integral members of the healthcare team.²⁷ The primary objective of patient-centered treatments is to enhance therapeutic results via identifying, preventing, and managing drug-related issues, promoting appropriate medication use, and providing general health education.²⁸ In Iraq, it has been observed that a significant number of chronic illnesses are not effectively addressed via the collaborative efforts of healthcare professionals, including pharmacists, despite their recognized position within the broader healthcare framework.²⁹ It is important to enhance the professional growth of pharmacists to enable them to carry out their duties proficiently. The concept of care centers on cultivating the pharmacist-patient relationship and strengthening the therapeutic result by active engagement in the treatment approach.³⁰

It has been shown that collaborative counseling may lead to a 3.6-fold decrease in stress levels among infertile women undergoing in vitro fertilization (IVF) compared to a control group. Psychotherapy emerges as a compelling treatment option due to its efficacy in enhancing patients’ likelihood of achieving pregnancy.³¹ Psychological counseling, interpersonal therapy, and behavioral activation are often used as the first treatment modalities for depression.³² Several studies have shown that infertile women seeking to undergo in vitro fertilization (IVF) may have unsuccessful outcomes and fail to achieve pregnancy due to pre-existing depressive symptoms in the patient.³³^,³⁴ Consequently, it is essential to implement health education and raise awareness of the need to ensure a satisfying state before undergoing surgery, with a particular emphasis on women due to their heightened vulnerability to this kind of depression in comparison to males.³⁵

The primary goal of this study was the assessment of clinical pregnancy rates as a measure of the result of in vitro fertilization cycles after the introduction of educational support program by the clinical pharmacist. Secondary outcome measures were the completion of The Centre for Epidemiological Studies Depression Scale (CES-D) and The Fertility Quality of Life Tool (FertiQoL) evaluation by both groups at the beginning and end of the in vitro fertilization process.

Method

Trial registration

This study was registered on Clinical Trials.gov (NCT06022640).

Ethics

The ethics committee of the College of Pharmacy at Mustansiriyah University, Iraq, formally approved the research methodology. Written consent was acquired from every individual enrolled in the study after providing a comprehensive explanation of the study’s objectives and maintaining the confidentiality of patient information.

Study design

This study used a prospective two arms parallel-group in an interventional randomized control trial design to examine the effects of an educational support program led by a clinical pharmacist on the pregnancy rate of infertile females who completed in vitro fertilization cycles and had symptoms of depression. Research including a sample of 206 women experiencing infertility and using in vitro fertilization technology (Figure 1). However, 32 participants were excluded from the study because they failed to match the predetermined inclusion criteria. Out of the total sample size of 174 women experiencing infertility, 24 individuals declined participation, while 150 individuals consented to participate in the research, as seen in CONSORT flow diagram below.³⁶ The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an instructional and supporting program specifically developed by a clinical pharmacist. The intervention group was assisted via a series of five visits, including an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and any negative effects, and visits dedicated to giving emotional support. A follow-up visit was also conducted after the egg harvesting process and embryo transfer. The control group comprised 75 married women experiencing infertility and seeking treatment at the hospital. These women were handled according to the standard practice used by the hospital system.

Figure 1. CONSORT flow diagram.³⁶

Study setting

This research recruited infertile females’ participants seeking pregnancy at the Kamal Al-Samaraie hospital, a government-run infertility facility located in Baghdad, Iraq, from January 1^st 2022 to July 1^st 2022.

Inclusion criteria

To qualify for inclusion in the research, participants must satisfy certain criteria. These requirements included being a woman experiencing infertility (the inability to conceive after at least one year of marriage). To be within the reproductive age (18-45 years old) and to have the ability to read and understand.

Exclusion criteria

The exclusion criteria for the patients includes those who had experienced past failure of an in vitro fertilization. Morbid obesity (a body mass index (BMI) over 40).³⁷ Individuals under consideration to have mental conditions that necessitate their admittance to a psychiatric institution, or those grappling with addiction or having progressive neurological disorders. Any individual who has a condition that hinders their ability to engage in effective communication due to challenges related to language and hearing.

Variables

The primary objective of the research was to examine the correlation between the pregnancy rate of infertile females who underwent in vitro fertilization (IVF) cycles and the presence of accompanying depressive symptoms throughout this process. The CES-D scale was used to evaluate the level of depression in each participant. The CES-D questionnaire is a standardized evaluation consisting of 20 items that prompts individuals to evaluate the frequency with which they experienced symptoms associated with depression over the course of the preceding week.³⁸ The CES-D utilizes cutoff values of 16 or above in order to identify individuals who may be at risk of experiencing clinical depression. Elevated scores are indicative of a greater manifestation of depressive symptoms. The assessment has exceptional levels of sensitivity, specificity, and internal consistency and has been successfully used in many age groups.

The FertiQoL questionnaire is a widely recognized instrument for assessing the quality of life related to fertility. It examines the impact of reproductive challenges on multiple aspects of individuals’ lives, encompassing overall well-being, self-perception, emotional states, interpersonal relationships, familial and social ties, occupational satisfaction, and aspirations for the future. The questionnaire has been translated into a total of 20 languages, which notably includes Arabic.³⁹ The present research evaluated the FertiQoL at two distinct time points: before to the implementation of the management program and subsequent to the completion of embryo transfer.

Educational program

The intervention that was given was educational that disseminate knowledge related to the issue of infertility. The education interventions consisted of comprehensive information associated with the pathophysiology of infertility, etiological factors, guidelines for therapy, strategies for managing psychological distress, techniques for stress reduction, and encouraging the development of healthy interpersonal connections. The objective of educational interventions is to enhance the health literacy of women experiencing infertility. The instructional materials used in this study were adopted from evidence-based guidelines involving disseminating educational resources focused on psychological assistance for individuals experiencing infertility.⁴⁰^–⁴²

Randomization

A computerized randomization method was used to allocate patients into two groups in a randomized manner. Following the first interview, the patients were sequentially assigned numbers and then randomized into two groups via the online program Research Randomizer.

Sample size

The recommended minimum sample size is calculated according to the formula:

n = {z2}^{*} p^{*} (1 - p) / e2

Where: z = 1.96 for a confidence level (α) of 95%, p = prevalence of infertility which was reported to be as high as 8.9% among the general population,⁴³ e = margin of error e = 0.05. The minimum sample size was equal to 125.

Statistical analysis

The data collected was entered into Microsoft Excel 2021 (RRID: SCR_016137) and then inserted into SPSS statistical software/version 26 (RRID: SCR 016479). The Chi-Square Test was performed to determine the significance of relationships between related categorical variables. The independent-sample T-test was used to assess the significance of numerical variables in the intervention and control groups at the beginning and end of the trial in terms of FertiQoL score and depression score. The 95% confidence interval has been set. The P-value of 0.05 was used as the cutoff for significance.

Results

A total of 150 infertile females exposed to IVF procedures were eligible for the study (Table 1).

Table 1. Participants’ baseline data (n = 150).

Characteristic	N	Minimum	Maximum	Mean	SD
Age in years	150	19	45	30.32	5.64
Duration of marriage in years	150	1	12	3.74	2.17
BMI	150	19.5	39.5	27.12	3.57

The study found no significant association between group of study and age, duration of marriage and BMI (body mass index) (Table 2).

Table 2. The distribution of patients' characteristics based on their assigned study groups.

Patients’ characteristics	Control group (75 patients)	Interventional group (75 patients)	P-value
Patients’ characteristics	mean ± SD		P-value
Age (in years)	30.88 ± 5.61	29.76 ± 5.66	0.225 (NS)
BMI	27.5051 ± 3.71172	26.7505 ± 3.41797	0.197 (NS)
Duration of marriage	4.0000 ± 2.18100	3.4800 ± 2.15206	0.144 (NS)

* Independent sample T-test was used compare two distinct samples. NS: No significant differences (P-value > 0.05).

According to the data shown in Table 3, the average pre-FertiQoL score for the control group is 53.48 ± 13.98, which is statistically insignificant from the average score of 51.66 ± 14.87 for the interventional group (P-value = 0.443). While the FertiQoL measured at post-time (post-FertiQoL) was found to be significantly higher among the interventional group, P-value = 0.025.

Table 3. A comparison of FertiQoL score averages between the research groups.

	Group	N	Mean	Std. Deviation	*p-value
Pre-FertiQoL	Control	75	53.48	13.98	0.443 (NS)
Pre-FertiQoL	Interventional	75	51.66	14.87	0.443 (NS)
Post-FertiQoL	Control	75	53.33	13.20	0.025 (S)
Post-FertiQoL	Interventional	75	58.47	14.51	0.025 (S)

* Independent sample T-test was used compare two distinct samples. NS: No significant differences (P-value > 0.05), S (P-value ≤ 0.05) is considered significant.

The CES-D provides cutoff scores (16 or greater) that aid in identifying individuals at risk for clinical depression, with good sensitivity and specificity and high internal consistency.⁴⁴ The cutoff point of 16 was considered to be indicative of mild depression, and the degree of depression was shown to rise as the score increased.⁴⁵ The percentage of at-risk participants evaluated for depression dropped from 83% at the beginning to 69% at the end of the study, as shown in Figure 2.

Figure 2. At-risk participants evaluated for depression.

The overall risk of depression in the interventional group was considerably reduced compared to the control group at the end of the study, with a P-value of 0.001 (as presented in Table 4).

Table 4. Time-dependent association between study groups and the risk of developing depression.

Time of measurement	Group of study	Risk		No risk		*P-value
Time of measurement	Group of study	N	%	N	%	*P-value
Start-time	Control	65	86.7%	10	13.3%	0.273 (NS)
Start-time	Interventional	60	80.%	15	20%	0.273 (NS)
End-time	Control	67	89.3%	8	10.7%	0.001 (S)
End-time	Interventional	36	48%	39	52%	0.001 (S)

* Chi-square is used for statistical analysis of descriptive parameters. NS: No significant differences (P-value > 0.05), S (P-value ≤ 0.05) is considered significant.

The interventional group exhibited a significantly greater rate of positive pregnancy (48%) compared to the control group (29.3%), as shown by a P-value of 0.019 (Table 5).

Table 5. Relationship between pregnancy prognosis and the groups being studied.

		Negative		Positive		*P-value
		N	%	N	%	*P-value
Group	Control	53	70.7%	22	29.3%	0.019S
Group	Interventional	39	52.0%	36	48.0%	0.019S

* Chi-square is used for statistical analysis of descriptive parameters. S (P-value ≤ 0.05) is considered significant.

There was no statistically significant difference seen between the pre-FertiQoL and post-FertiQoL scores among the research participants who had a negative pregnancy outcome. The p-values for the two variables were 0.795 and 0.497, respectively. The post-FertiQoL mean score in the interventional group was substantially higher compared to the control group among individuals who had positive pregnancy outcomes P-value = 0.016 (Table 6). A statistically significant difference was seen among participants in terms of their depressive condition after the completion of the IVF cycles, including between those with a positive pregnancy result and those with a negative outcome (Table 7).

Table 6. Time-dependent variances in FertiQoL scores mean per study group and pregnancy outcome.

Pregnancy status	Time of measurements	Group	N	Mean	Std. Dev.	*P-value
Negative	Pre FertiQoL	Control	53	54.40	14.29	0.795 (NS)
	Pre FertiQoL	Interventional	39	53.63	13.59	0.795 (NS)
	Post FertiQoL	Control	53	53.55	13.72	0.497 (NS)
	Post FertiQoL	Interventional	39	55.60	14.96	0.497 (NS)
Positive	Pre FertiQoL	Control	22	51.26	13.27	0.674 (NS)
	Pre FertiQoL	Interventional	36	49.53	16.06	0.674 (NS)
	Post FertiQoL	Control	22	52.81	12.13	0.016 (S)
	Post FertiQoL	Interventional	36	61.58	13.52	0.016 (S)

* Independent sample T-test was used compare two distinct samples. NS: No significant differences (P-value > 0.05), S (P-value ≤ 0.05) is considered significant.

Table 7. Time-dependent variances in FertiQoL scores mean per study group and pregnancy outcome.

Pregnancy status	Time of measurement	Depression status	Group
			Control		Interventional
			N	N %	N	N %	*P-value
Negative	Pre CES-D	No risk	4	7.5%	6	15.4%	0.233 (NS)
	Pre CES-D	Risk	49	92.5%	33	84.6%	0.233 (NS)
	Post CES-D	No risk	3	5.7%	18	46.2%	0.0001 (HS)
	Post CES-D	Risk	50	94.3%	21	53.8%	0.0001 (HS)
Positive	Pre CES-D	No risk	3	13.6%	6	16.7%	0.757 (NS)
	Pre CES-D	Risk	19	86.4%	30	83.3%	0.757 (NS)
	Post CES-D	No risk	3	13.6%	20	55.6%	0.002 (HS)
	Post CES-D	Risk	19	86.4%	16	44.4%	0.002 (HS)

* Chi-square is used for statistical analysis of descriptive parameters. NS: No significant differences (P-value > 0.05), HS (P-value <0.01) considered highly significant value.

Discussion

Individuals experiencing difficulties in achieving conception often experience symptoms of despair and anxiety.⁴⁶ Research has shown that infertile women have emotional issues comparable to those struggling with malignancies.⁴⁷ Infertility is a widespread public health concern that has many medical, psychological, and social consequences.⁴⁸ Depression may influence an individual’s cognitive processes, behaviors, emotional experiences, and overall state of health.

We performed a randomized controlled trial to evaluate the impact of supportive and educational intervention on depression scores and pregnancy outcomes in infertile women. The present research reveals that women who are facing infertility issues and actively seeking medical intervention had been in a marital relationship for an average duration of 3.74 ± 2.17 years, with the longest reported duration being 12 years. According to the findings of an earlier study carried out in the Erbil Kurdistan Region of Iraq, it was observed that a majority of 55.5% of women experiencing infertility and actively seeking infertility treatment had been married for a length ranging from 3 to 7 years.⁴⁹ Based on available research, the average period of infertility in India is around 8.38 years.⁵⁰ In Korea, this time is estimated to be around four years.⁵¹ In Italy, it has been observed that over fifty percent of couples choose Assisted Reproductive Technology (ART) after being married for less than 3 years.⁵² The observed variations may be attributed to the distinct sociocultural characteristics of each nation.

The objective of this research is to enhance awareness of the fertility-related quality of life among women who are facing infertility and to demonstrate the impact of supportive care on their quality of life. The quality of life experienced by women enduring infertility therapy may be substantially decreased. The quality of life experienced by women enduring infertility therapy may be substantially decreased. This phenomenon has the potential to induce treatment discontinuation and possibly generate resistance against seeking assistance from the patient.⁵³

The present study analyses the quality of life experienced by infertile women in Iraq who receive in vitro fertilization (IVF) treatment. The average FertiQoL score at the beginning of the study (before implementing any interventions) was 53.48 ± 13.98 for the control group and 51.66 ± 14.87 for the intervention group. The baseline mean of all included cases was calculated to be 52.57 ± 14.417. The findings of this study revealed a significant gap in the assessment of quality of life among infertile women compared to a survey conducted in Kazakhstan. In the Kazakh study, 453 infertile women who received IVF treatment reported a FertiQoL score of (59.6 ± 11.5), with a P-value of 0.001.⁵⁴ The findings presented in research conducted in Germany, Italy, France, Poland, and Taiwan showed substantial and statistically significant variations.⁵⁵^–⁵⁷ Potential factors contributing to this observed disparity may include elevated living standards and increased accessibility to mental health care within these industrialized nations.

The findings of the comparative analysis conducted on different study groups about FertiQoL indicate that no statistically significant differences were seen during the first assessment. However, it was observed that the intervention group had markedly elevated levels compared to the control group at the end of the study. The observed effect is hypothesized to be attributable to supportive care’s impact on enhancing the experimental cohort’s overall well-being. This finding aligns with previous research on Iranian women experiencing infertility, whereby the group that received counseling had a notably higher average score in terms of quality of life than the control group.⁵⁸

The research findings indicate that the initial prevalence of depression among all participants included in the study at the beginning of the in vitro fertilization cycle was 83%. The results presented in this research are similar to another study in Kazakhstan, whereby a sample of 304 females experiencing infertility were interviewed across three distinct locations. The results indicated that over 80% of respondents exhibited CES-D scores of 16 or above, indicating a greater susceptibility to the onset of clinical depression. The above rate has decreased to 69% following the implementation of educational interventions and supporting measures for females experiencing infertility after the in vitro fertilization cycle is completed. During the examination of the interventional group’s depression state before and after the in vitro fertilization cycle, it was observed that the prevalence of depression decreased from 80% to 48%.

There was no statistically significant difference in depression scale scores between the control and intervention groups at the beginning of the study (p-value = 0.273). However, at the end of the study, there was a significant difference in depression scale ratings between the two groups (p-value = 0.001). The observed decline may be attributed to the provision of educational and supportive care within the IVF program. This finding is consistent with previous research in which a statistically significant difference in the outcome was observed after the intervention was carried out, providing further support for the present conclusion.⁵⁹^,⁶⁰ Providing patients with psychological interventions and emotional support is crucial for infertility healthcare professionals.⁶¹

The research findings revealed that the favorable conception rate differed between the control and intervention groups regarding IVF outcome rates, with 29.3% and 48%, respectively. The results of this study suggest that the intervention group exhibited a 1.6-fold increase in the likelihood of achieving pregnancy compared to the control group. The findings above were deemed similar to those of another research done in Brazil, whereby the intervention group exhibited a notably higher pregnancy rate (39.8%) compared to the control group 23.2%.⁶²

The intervention group exhibits a greater proportion of positive pregnant women than the control group, with 29.3% and 48%, respectively. Additionally, the overall pregnancy success rate for all participants is 39%. Initially, it was seen that both groups exhibited similar levels of FertiQoL about the outcome of a positive or negative pregnancy test. The female individuals in the intervention group showed a notable enhancement in FertiQoL compared to the control group towards the end of the research. Furthermore, significant variations in pregnancy rates were seen across the groups, with the intervention group exhibiting a greater rate than the control group. Consequently, after providing information and comprehensive assistance, the enhancement of FertiQoL shows a positive correlation with the incidence of successful pregnancies. This is similar to a research study conducted among a cohort of Chinese women receiving their first in vitro fertilization procedure at a specialized reproductive clinic.⁶³

Study limitations

This research has several limitations; the first is related to the measurements used. The present study used self-report measures exhibiting inherent limitations, such as a potential deficiency in self-awareness. Another limitation is the absence of control over individual aspects. Participants may have exaggerated the impact of the intervention due to personal drive, optimism, and related variables. In future research investigations, it is advisable to include pseudo-therapy programs, also called placebo programs, inside control groups to mitigate the influence of anticipation effects. Finally, the participants were recruited from Kamal Al-Samaraie Hospital in Baghdad, Iraq, and had undergone an in vitro fertilization treatment cycle. Researchers should implement programs on additional individuals in other healthcare facilities to broaden the scope of the study’s results.

Conclusion

Infertile women who undergo IVF operations have higher rates of depression. Depression may be reduced, and quality of life improved with education and supportive counseling. Pregnancy rates rise as a result of clinical pharmacist counseling.

Data availability

Underlying data

Zenodo: The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial, https://doi.org/10.5281/zenodo.8348310.⁶⁴

This project contains the following underlying data:

• RCT data.xlsx (Demographic details, as well as questionnaire scores)

Extended data

Zenodo: Trial protocol for the assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial, https://doi.org/10.5281/zenodo.10076029.⁶⁵

This project contains the following extended data:

• Trial protocol.pdf

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY).

Reporting guidelines

Zenodo: CONSORT Checklist for ‘The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial’, https://doi.org/10.5281/zenodo.8348485.⁶⁶

Zenodo: CONSORT flow diagram for ‘The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial’, https://doi.org/10.5281/zenodo.10075894.³⁶

Trial registration: This study was registered on Clinical Trials.gov (NCT06022640).

Acknowledgment

The authors express their gratitude to everyone who participated in our recruiting process, demonstrating their keen interest in and endorsement of our study.

References

1. Rimer L: The effect of family structure and family support on women’s coping with fertility treatments. Int. J. Nurs. 2020; 7(1): 18–29. Publisher Full Text
2. Sharma A, Shrivastava D, Sharma IA: Psychological Problems Related to Infertility. Cureus. 2022; 14: 10. Publisher Full Text
3. Samman SK, Frick HA, Dansby Olufowote RA: Medical Family Therapy with Diverse Populations Part I: interracial Couples Navigating Infertility, Racialized Pregnancy, and Pregnancy Loss. Int. J. Systemic Ther. 2022; 33(4): 227–249. Publisher Full Text
4. Maleki-Saghooni N, Amirian M, Sadeghi R, et al.: Effectiveness of infertility counseling on pregnancy rate in infertile patients undergoing assisted reproductive technologies: A systematic review and meta-analysis. Int. J. Reprod. Biomed. 2017; 15(7): 391–402. PubMed Abstract | Publisher Full Text
5. Kiani Z, Simbar M, Hajian S, et al.: The prevalence of depression symptoms among infertile women: a systematic review and meta-analysis. Fertil. Res. Pract. 2021; 7: 1–10. Publisher Full Text
6. Carson SA, Kallen AN: Diagnosis and management of infertility: a review. JAMA. 2021; 326(1): 65–76. PubMed Abstract | Publisher Full Text | Free Full Text
7. Liu X, Li J, Wang W, et al.: Therapeutic restoration of female reproductive and endocrine dysfunction using stem cells. Life Sci. 2023; 322: 121658. PubMed Abstract | Publisher Full Text
8. Bakkensen JB, Goldman KN: Women’s preventive services initiative: fertility counseling overlooked. Am. J. Obstet. Gynecol. 2022; 226(4): 524–528. PubMed Abstract | Publisher Full Text
9. Skakkebaek NE, Lindahl-Jacobsen R, Levine H, et al.: Environmental factors in declining human fertility. Nat. Rev. Endocrinol. 2022; 18(3): 139–157. Publisher Full Text
10. Medenica S, Zivanovic D, Batkoska L, et al.: The Future Is Coming: Artificial Intelligence in the Treatment of Infertility Could Improve Assisted Reproduction Outcomes—The Value of Regulatory Frameworks. Diagnostics. 2022; 12(12): 2979. PubMed Abstract | Publisher Full Text | Free Full Text
11. Koivu AM, Näsänen-Gilmore PK, Hunter PJ, et al.: Antenatal interventions to address harmful behaviors and psychosocial risk factors in the prevention of low birth weight. Am. J. Clin. Nutr. 2023; 117: S148–S159. PubMed Abstract | Publisher Full Text
12. Cyranoski D, Contreras JL, Carrington VT: Intellectual property and assisted reproductive technology. Nat. Biotechnol. 2023; 41(1): 14–20. PubMed Abstract | Publisher Full Text
13. Liu Y-F, Fu Z, Chen S-W, et al.: The analysis of anxiety and depression in different stages of in vitro fertilization-embryo transfer in couples in China. Neuropsychiatr. Dis. Treat. 2021; 17: 649–657. Publisher Full Text
14. Bendarska-Czerwińska A, Zmarzły N, Morawiec E, et al.: Endocrine disorders and fertility and pregnancy: An update. Front. Endocrinol. 2023; 13: 970439. PubMed Abstract | Publisher Full Text | Free Full Text
15. Graham ME, Jelin A, Hoon AH Jr, et al.: Assisted reproductive technology: Short-and long-term outcomes. Dev. Med. Child Neurol. 2023; 65(1): 38–49. PubMed Abstract | Publisher Full Text | Free Full Text
16. Njogu A, Njogu J, Mutisya A, et al.: Experiences of infertile women pursuing treatment in Kenya: a qualitative study. BMC Womens Health. 2022; 22(1): 1–17. Publisher Full Text
17. Bosenge-Nguma J-D, O’yandjo AM, Sihalikyolo J, et al.: Tertiary care for infertile couples: aetiological diagnoses and conventional treatment outcomes in Kisangani, Democratic Republic of the Congo. Contracept. Reprod. Med. 2023; 8(1): 36. PubMed Abstract | Publisher Full Text | Free Full Text
18. Aimagambetova G, Issanov A, Terzic S, et al.: The effect of psychological distress on IVF outcomes: Reality or speculations? PLoS One. 2020; 15(12): e0242024. PubMed Abstract | Publisher Full Text | Free Full Text
19. Cover J, Namagembe A, Morozoff C, et al.: Contraceptive self-injection through routine service delivery: Experiences of Ugandan women in the public health system. Front. Glob. Womens Health. 2022; 3: 911107. PubMed Abstract | Publisher Full Text | Free Full Text
20. Bapayeva G, Aimagambetova G, Issanov A, et al.: The effect of stress, anxiety and depression on in vitro fertilization outcome in kazakhstani public clinical setting: a cross-sectional study. J. Clin. Med. 2021; 10(5): 937. PubMed Abstract | Publisher Full Text | Free Full Text
21. De Boer ML, Bondevik H, Solbraekke KN: Beyond pathology: women’s lived experiences of melancholy and mourning in infertility treatment. Med. Humanit. 2020; 46(3): 214–225. PubMed Abstract | Publisher Full Text | Free Full Text
22. Simionescu G, Doroftei B, Maftei R, et al.: The complex relationship between infertility and psychological distress. Exp. Ther. Med. 2021; 21(4): 1.
23. Maroufizadeh S, Navid B, Omani-Samani R, et al.: The effects of depression, anxiety and stress symptoms on the clinical pregnancy rate in women undergoing IVF treatment. BMC. Res. Notes. 2019; 12(1): 1–4.
24. Söderlund J, Simonsen J, Alanko K, et al.: Tweens: A Positive Psychology Family Intervention for Adolescents with Depression-or Anxiety-related Symptomatology. Int. J. Appl. Posit. Psychol. 2023; 1–27. Publisher Full Text
25. Kamusheva M, Ignatova D, Golda A, et al.: The potential role of the pharmacist in supporting patients with depression–a literature-based point of view. Integr. Pharm. Res. Pract. 2020; 9: 49–63. PubMed Abstract | Publisher Full Text | Free Full Text
26. Galozy A, Nowaczyk S, Sant’Anna A, et al.: Pitfalls of medication adherence approximation through EHR and pharmacy records: definitions, data and computation. Int. J. Med. Inform. 2020; 136: 104092. PubMed Abstract | Publisher Full Text
27. Weidmann AE, Hoppel M, Deibl S: “It is the future. Clinical pharmaceutical care simply has to be a matter of course.”-Community pharmacy clinical service providers’ and service developers’ views on complex implementation factors. Res. Soc. Adm. Pharm. 2022; 18(12): 4112–4123. PubMed Abstract | Publisher Full Text
28. Ilardo ML, Speciale A: The community pharmacist: perceived barriers and patient-centered care communication. Int. J. Environ. Res. Public Health. 2020; 17(2): 536. PubMed Abstract | Publisher Full Text | Free Full Text
29. Namiq HS, Obeid KA, Mohammed DA: Role of pharmaceutical care in type 2 diabetic patients in kirkuk city. Al Mustansiriyah Journal of Pharmaceutical Sciences. 2020; 20(4): 169–181. Publisher Full Text
30. Chillab RZ, Al-Sabbagh M, Fakhri H: Evaluation of pharmaceutical care application in Iraqi hospital. Al Mustansiriyah Journal of Pharmaceutical Sciences. 2009; 6(1): 18–31. Publisher Full Text
31. El-Feshawy NI, Zromba AM, El-Ansary E-S: Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction among Women Undergoing in vitro Fertilization a Randomized Control Trial. Assiut Scientific Nurs. J. 2023; 11(37): 1–13.
32. Lee E, Han Y, Cha YJ, et al.: Community-based multi-site randomized controlled trial of behavioral activation for patients with depressive disorders. Community Ment. Health J. 2022; 1–13.
33. Fernandez-Ferrera C, Llaneza-Suarez D, Fernandez-Garcia D, et al.: Resilience, perceived stress, and depressed mood in women under in vitro fertilization treatment. Reprod. Sci. 2022; 29(3): 816–822. PubMed Abstract | Publisher Full Text | Free Full Text
34. Gabnai-Nagy E, Bugán A, Bodnár B, et al.: Association between emotional state changes in infertile couples and outcome of fertility treatment. Geburtshilfe Frauenheilkd. 2020; 80(02): 200–210. Publisher Full Text
35. Geoffrion R, Koenig NA, Zheng M, et al.: Preoperative depression and anxiety impact on inpatient surgery outcomes: a prospective cohort study. Ann. Surg. Open. 2021; 2(1): e049. PubMed Abstract | Publisher Full Text | Free Full Text
36. Ibrahim AA: CONSORT flow diagram for The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial.2023. Publisher Full Text
37. Booth HP, Charlton J, Gulliford MC: Socioeconomic inequality in morbid obesity with body mass index more than 40 kg/m2 in the United States and England. SSM Popul. Health. 2017; 3: 172–178. PubMed Abstract | Publisher Full Text | Free Full Text
38. Van Dam NT, Earleywine M: Validation of the Center for Epidemiologic Studies Depression Scale—Revised (CESD-R): Pragmatic depression assessment in the general population. Psychiatry Res. 2011; 186(1): 128–132. PubMed Abstract | Publisher Full Text
39. Boivin J, Takefman J, Braverman A: The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum. Reprod. 2011; 26(8): 2084–2091. PubMed Abstract | Publisher Full Text | Free Full Text
40. Bach M: Psychosocial interventions for individuals with infertility.2018.
41. Kremer F, Ditzen B, Wischmann T: Effectiveness of psychosocial interventions for infertile women: A systematic review and meta-analysis with a focus on a method-critical evaluation. PLoS One. 2023; 18(2): e0282065. PubMed Abstract | Publisher Full Text | Free Full Text
42. Ha J-Y, Park H-J, Ban S-H: Efficacy of psychosocial interventions for pregnancy rates of infertile women undergoing in vitro fertilization: a systematic review and meta-analysis. J. Psychosom. Obstet. Gynecol. 2023; 44(1): 2142777. PubMed Abstract | Publisher Full Text
43. Katole A, Saoji AV: Prevalence of Primary Infertility and its Associated Risk Factors in Urban Population of Central India: A Community-Based Cross-Sectional Study. Indian J. Community Med. 2019; 44(4): 337–341. PubMed Abstract | Publisher Full Text | Free Full Text
44. Lewinsohn PM, Seeley JR, Roberts RE, et al.: Center for Epidemiologic Studies Depression Scale (CES-D) as a screening instrument for depression among community-residing older adults. Psychol. Aging. 1997; 12(2): 277–287. PubMed Abstract | Publisher Full Text
45. Irwin M, Artin KH, Oxman MN: Screening for depression in the older adult: criterion validity of the 10-item Center for Epidemiological Studies Depression Scale (CES-D). Arch. Intern. Med. 1999; 159(15): 1701–1704. Publisher Full Text
46. Greil AL, Slauson-Blevins K, McQuillan J: The experience of infertility: a review of recent literature. Sociol. Health Illn. 2010; 32(1): 140–162. Publisher Full Text
47. Rooney KL, Domar AD: The relationship between stress and infertility. JDicn. 2022.
48. Moeenizadeh M, Zarif H: The efficacy of well-being therapy for depression in infertile women. Int. J. Fertil. Steril. 2017; 10(4): 363–370. PubMed Abstract
49. Gardi AHH, Mohammed SH: Assessment of Psychological status of Infertile Women in Erbil Kurdistan Region. kufa Journal for Nursing sciences. 2013; 3(1): 149–160. Publisher Full Text
50. Malhotra N, Bahadur A, Singh N, et al.: Does obesity compromise ovarian reserve markers? A clinician’s perspective. Arch. Gynecol. Obstet. 2013; 287: 161–166. PubMed Abstract | Publisher Full Text
51. Yoo JH, Cha SH, Park CW, et al.: Comparison of mild ovarian stimulation with conventional ovarian stimulation in poor responders. Clin. Exp. Reprod. Med. 2011; 38(3): 159–163. PubMed Abstract | Publisher Full Text | Free Full Text
52. Chiaffarino F, Baldini MP, Scarduelli C, et al.: Prevalence and incidence of depressive and anxious symptoms in couples undergoing assisted reproductive treatment in an Italian infertility department. Eur. J. Obstet. Gynecol. Reprod. Biol. 2011; 158(2): 235–241. Publisher Full Text
53. Song D, Li X, Yang M, et al.: Fertility quality of life (FertiQoL) among Chinese women undergoing frozen embryo transfer. BMC Womens Health. 2021; 21(1): 1–7. Publisher Full Text
54. Suleimenova M, Lokshin V, Glushkova N, et al.: Quality-of-Life Assessment of Women Undergoing in vitro Fertilization in Kazakhstan. Int. J. Environ. Res. Public Health. 2022; 19(20): 13568. PubMed Abstract | Publisher Full Text | Free Full Text
55. Madero S, Gameiro S, García D, et al.: Quality of life, anxiety and depression of German, Italian and French couples undergoing cross-border oocyte donation in Spain. Hum. Reprod. 2017; 32(9): 1862–1870. PubMed Abstract | Publisher Full Text
56. Wdowiak A, Anusiewicz A, Bakalczuk G, et al.: Assessment of quality of life in infertility treated women in Poland. Int. J. Environ. Res. Public Health. 2021; 18(8): 4275. PubMed Abstract | Publisher Full Text | Free Full Text
57. Hsu P-Y, Lin M-W, Hwang J-L, et al.: The fertility quality of life (FertiQoL) questionnaire in Taiwanese infertile couples. Taiwan. J. Obstet. Gynecol. 2013; 52(2): 204–209. PubMed Abstract | Publisher Full Text
58. Golshani F, Mirghafourvand M, Hasanpour S, et al.: The effect of cognitive behavioral therapy on anxiety and depression in Iranian infertile women: a systematic and meta-analytical review. Iran. J. Psychiatry Behav. Sci. 2020; 14(1). Publisher Full Text
59. Shirin A, Atefeh A, Mahlegha D, et al.: The effect of cognitive behavior therapy on attitude of infertile individuals toward child adoption. J. Prev. Med. Hyg. 2022; 63(1): E97–E103. PubMed Abstract | Publisher Full Text
60. Faramarzi M, Alipor A, Esmaelzadeh S, et al.: Treatment of depression and anxiety in infertile women: cognitive behavioral therapy versus fluoxetine. J. Affect. Disord. 2008; 108(1-2): 159–164. Publisher Full Text
61. Rooney KL, Domar AD: The relationship between stress and infertility. Dialogues Clin. Neurosci. 2022.
62. Gorayeb R, Borsari ACT, Rosa-e-Silva ACJS, et al.: Brief cognitive behavioral intervention in groups in a Brazilian assisted reproduction program. Behav. Med. 2012; 38(2): 29–35. PubMed Abstract | Publisher Full Text
63. Li J, Long L, Liu Y, et al.: Effects of a mindfulness-based intervention on fertility quality of life and pregnancy rates among women subjected to first in vitro fertilization treatment. Behav. Res. Ther. 2016; 77: 96–104. PubMed Abstract | Publisher Full Text
64. Ibrahim AA: The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial.2023. Publisher Full Text
65. Ibrahim AA: Trial protocol for the assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial.2023. Publisher Full Text
66. Ibrahim AA: CONSORT Checklist for The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial.2023. Publisher Full Text

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 14 Dec 2023

Author details Author details

¹ Clinical Pharmacy, College of Pharmacy, Mustansiriyah University, Baghdad, 10081, Iraq

Ali Abbas Ibrahim
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Software, Visualization, Writing – Original Draft Preparation

Abeer Abdulhadi Rashid
Roles: Conceptualization, Formal Analysis, Methodology, Supervision, Validation, Visualization, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 14 Dec 2023, 12:1592

https://doi.org/10.12688/f1000research.142587.1

Copyright

© 2023 Abbas Ibrahim A and Abdulhadi Rashid A. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

	Views	Downloads
F1000Research	-	-
PubMed Central Data from PMC are received and updated monthly.	-	-

Citations

0

SEE MORE DETAILS

CITE

how to cite this article

Abbas Ibrahim A and Abdulhadi Rashid A. The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial [version 1; peer review: 1 approved with reservations, 1 not approved]. F1000Research 2023, 12:1592 (https://doi.org/10.12688/f1000research.142587.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Version 1

VERSION 1

PUBLISHED 14 Dec 2023

Views

3

Reviewer Report 09 May 2024

Unyime Israel Eshiet, University of Uyo, Uyo, Akwa Ibom, Nigeria

Approved with Reservations

https://doi.org/10.5256/f1000research.156154.r257240

General Comment:
A brilliant study with important findings of public health importance.

Abstract:

Well structured. However, does not capture important details.

Method:

General Comment:
A brilliant study with important findings of public health importance.

Abstract:

Well structured. However, does not capture important details.

Method:

Not properly presented.
What type of study was conducted? Cross-sectional? Randomized control? Case control? Etc. Please explain.
"The intervention group received an educational program consisting of five visits” - what was the interval between each clinic visit?
What statistical application was used to run the analysis?

Results:

“No statistically significant difference was seen in the FertiQoL evaluation scores between the control and intervention groups at the beginning of the study. The FertiQoL, assessed at the end of the trial, exhibited a statistically significant increase in the interventional group." - kindly present the statistical values.

Conclusion:

Does not reflect the objectives of the study as no mention is made of the impact of pharmacists’ counselling on the quality of life and depression scores of the study population.

Introduction:

Highlights importance of the study. However, the authors should make it more concise and straight to the point.

Methods:

Satisfactory.

Results:

Well presented.

Discussion:

Authors have not satisfactorily discussed their results in comparisons with previous studies.
Some important aspects of the results presented is not discussed.

Conclusion:

Does not reflect the objectives of the study as no mention is made of the impact of pharmacists’ counselling on the quality of life and depression scores of the study population.

References:

Authors should ensure that the references comply with the recommended referencing style of the journal.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Views

4

Reviewer Report 22 Jan 2024

Meng-Hsing Wu, Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University, Tainan City, Tainan City, Taiwan

Not Approved

https://doi.org/10.5256/f1000research.156154.r232012

The authors tried to examine the correlation between the pregnancy rate of IVF female and the presentation of depression symptoms.

The authors need to use suitable analysis method to evaluate the correlation between the

The authors tried to examine the correlation between the pregnancy rate of IVF female and the presentation of depression symptoms.

The authors need to use suitable analysis method to evaluate the correlation between the pregnancy rate of IVF female and the presentation of depression symptoms, not just showed the results of pregnancy.
The exclusion criteria include the female who had past history of IVF cycle. Therefore, the authors need to more clearly demonstrate they were first time for IVF treatment due to different depression status after failure of embryo transfer. In addition, this is a prospective study. It seems not possible that these female all can receive fresh embryo transfer. The depression status between fresh and frozen embryo transfer should be different and it also possible that failure of TVOR and embryo transfer.
There are rare publications to evaluate clinical pharmacist for counseling infertility patients. In page 4 the educational program includes many psychologic strategies. If these pharmacists receive basic training for psychologic counselling and how many times they took for these procedures.
There are too many figures and tables those can write into the manuscript.
The total scores of FertiQoL are much lower than average of previous studies. For example, Fertility quality of life tool: update on research and practice considerations (Koert E et al, 2021)[Ref1] .The range of median FertiQoL Core, Treatment and subscale (scaled) scores was between 60 and 75. The authors need to explain the reason and further FertiQoL subscale scores analysis is need.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

References

1. Koert E, Takefman J, Boivin J: Fertility quality of life tool: update on research and practice considerations.Hum Fertil (Camb). 2021; 24 (4): 236-248 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: IVF

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

CITE

Report a concern

Respond or Comment

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 14 Dec 2023

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2
Version 1 14 Dec 23	read	read

Meng-Hsing Wu, National Cheng Kung University, Tainan City, Taiwan
Unyime Israel Eshiet, University of Uyo, Uyo, Nigeria

Comments on this article

All Comments(0)

Add a comment

Sign up for content alerts

Browse by related subjects

Back to all reports

Reviewer Report

3 Views

09 May 2024 | for Version 1

Unyime Israel Eshiet, University of Uyo, Uyo, Akwa Ibom, Nigeria

3 Views Cite this report Responses(0)

Approved With Reservations

General Comment:
A brilliant study with important findings of public health importance.

Abstract:

Well structured. However, does not capture important details.

Method:

Not properly presented.
What type of study was conducted? Cross-sectional? Randomized control? Case control? Etc. Please explain.
"The intervention group received an educational program consisting of five visits” - what was the interval between each clinic visit?
What statistical application was used to run the analysis?

Results:

“No statistically significant difference was seen in the FertiQoL evaluation scores between the control and intervention groups at the beginning of the study. The FertiQoL, assessed at the end of the trial, exhibited a statistically significant increase in the interventional group." - kindly present the statistical values.

Conclusion:

Does not reflect the objectives of the study as no mention is made of the impact of pharmacists’ counselling on the quality of life and depression scores of the study population.

Introduction:

Highlights importance of the study. However, the authors should make it more concise and straight to the point.

Methods:

Satisfactory.

Results:

Well presented.

Discussion:

Authors have not satisfactorily discussed their results in comparisons with previous studies.
Some important aspects of the results presented is not discussed.

Conclusion:

Does not reflect the objectives of the study as no mention is made of the impact of pharmacists’ counselling on the quality of life and depression scores of the study population.

References:

Authors should ensure that the references comply with the recommended referencing style of the journal.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Partly
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

4 Views

22 Jan 2024 | for Version 1

Meng-Hsing Wu, Department of Obstetrics and Gynecology, College of Medicine, National Cheng Kung University, Tainan City, Tainan City, Taiwan

4 Views Cite this report Responses(0)

Not Approved

The authors tried to examine the correlation between the pregnancy rate of IVF female and the presentation of depression symptoms.

The authors need to use suitable analysis method to evaluate the correlation between the pregnancy rate of IVF female and the presentation of depression symptoms, not just showed the results of pregnancy.
The exclusion criteria include the female who had past history of IVF cycle. Therefore, the authors need to more clearly demonstrate they were first time for IVF treatment due to different depression status after failure of embryo transfer. In addition, this is a prospective study. It seems not possible that these female all can receive fresh embryo transfer. The depression status between fresh and frozen embryo transfer should be different and it also possible that failure of TVOR and embryo transfer.
There are rare publications to evaluate clinical pharmacist for counseling infertility patients. In page 4 the educational program includes many psychologic strategies. If these pharmacists receive basic training for psychologic counselling and how many times they took for these procedures.
There are too many figures and tables those can write into the manuscript.
The total scores of FertiQoL are much lower than average of previous studies. For example, Fertility quality of life tool: update on research and practice considerations (Koert E et al, 2021)[Ref1] .The range of median FertiQoL Core, Treatment and subscale (scaled) scores was between 60 and 75. The authors need to explain the reason and further FertiQoL subscale scores analysis is need.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

No
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

No
Are all the source data underlying the results available to ensure full reproducibility?

No
Are the conclusions drawn adequately supported by the results?

No

References

1. Koert E, Takefman J, Boivin J: Fertility quality of life tool: update on research and practice considerations.Hum Fertil (Camb). 2021; 24 (4): 236-248 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

IVF

I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above.

Respond to this report

Responses (0)

[1] 1. Rimer L: The effect of family structure and family support on women’s coping with fertility treatments. Int. J. Nurs. 2020; 7(1): 18–29. Publisher Full Text

[2] 2. Sharma A, Shrivastava D, Sharma IA: Psychological Problems Related to Infertility. Cureus. 2022; 14: 10. Publisher Full Text

[3] 3. Samman SK, Frick HA, Dansby Olufowote RA: Medical Family Therapy with Diverse Populations Part I: interracial Couples Navigating Infertility, Racialized Pregnancy, and Pregnancy Loss. Int. J. Systemic Ther. 2022; 33(4): 227–249. Publisher Full Text

[4] 4. Maleki-Saghooni N, Amirian M, Sadeghi R, et al.: Effectiveness of infertility counseling on pregnancy rate in infertile patients undergoing assisted reproductive technologies: A systematic review and meta-analysis. Int. J. Reprod. Biomed. 2017; 15(7): 391–402. PubMed Abstract | Publisher Full Text

[5] 5. Kiani Z, Simbar M, Hajian S, et al.: The prevalence of depression symptoms among infertile women: a systematic review and meta-analysis. Fertil. Res. Pract. 2021; 7: 1–10. Publisher Full Text

[6] 6. Carson SA, Kallen AN: Diagnosis and management of infertility: a review. JAMA. 2021; 326(1): 65–76. PubMed Abstract | Publisher Full Text | Free Full Text

[7] 7. Liu X, Li J, Wang W, et al.: Therapeutic restoration of female reproductive and endocrine dysfunction using stem cells. Life Sci. 2023; 322: 121658. PubMed Abstract | Publisher Full Text

[8] 8. Bakkensen JB, Goldman KN: Women’s preventive services initiative: fertility counseling overlooked. Am. J. Obstet. Gynecol. 2022; 226(4): 524–528. PubMed Abstract | Publisher Full Text

[9] 9. Skakkebaek NE, Lindahl-Jacobsen R, Levine H, et al.: Environmental factors in declining human fertility. Nat. Rev. Endocrinol. 2022; 18(3): 139–157. Publisher Full Text

[10] 10. Medenica S, Zivanovic D, Batkoska L, et al.: The Future Is Coming: Artificial Intelligence in the Treatment of Infertility Could Improve Assisted Reproduction Outcomes—The Value of Regulatory Frameworks. Diagnostics. 2022; 12(12): 2979. PubMed Abstract | Publisher Full Text | Free Full Text

[11] 11. Koivu AM, Näsänen-Gilmore PK, Hunter PJ, et al.: Antenatal interventions to address harmful behaviors and psychosocial risk factors in the prevention of low birth weight. Am. J. Clin. Nutr. 2023; 117: S148–S159. PubMed Abstract | Publisher Full Text

[12] 12. Cyranoski D, Contreras JL, Carrington VT: Intellectual property and assisted reproductive technology. Nat. Biotechnol. 2023; 41(1): 14–20. PubMed Abstract | Publisher Full Text

[13] 13. Liu Y-F, Fu Z, Chen S-W, et al.: The analysis of anxiety and depression in different stages of in vitro fertilization-embryo transfer in couples in China. Neuropsychiatr. Dis. Treat. 2021; 17: 649–657. Publisher Full Text

[14] 14. Bendarska-Czerwińska A, Zmarzły N, Morawiec E, et al.: Endocrine disorders and fertility and pregnancy: An update. Front. Endocrinol. 2023; 13: 970439. PubMed Abstract | Publisher Full Text | Free Full Text

[15] 15. Graham ME, Jelin A, Hoon AH Jr, et al.: Assisted reproductive technology: Short-and long-term outcomes. Dev. Med. Child Neurol. 2023; 65(1): 38–49. PubMed Abstract | Publisher Full Text | Free Full Text

[16] 16. Njogu A, Njogu J, Mutisya A, et al.: Experiences of infertile women pursuing treatment in Kenya: a qualitative study. BMC Womens Health. 2022; 22(1): 1–17. Publisher Full Text

[17] 17. Bosenge-Nguma J-D, O’yandjo AM, Sihalikyolo J, et al.: Tertiary care for infertile couples: aetiological diagnoses and conventional treatment outcomes in Kisangani, Democratic Republic of the Congo. Contracept. Reprod. Med. 2023; 8(1): 36. PubMed Abstract | Publisher Full Text | Free Full Text

[18] 18. Aimagambetova G, Issanov A, Terzic S, et al.: The effect of psychological distress on IVF outcomes: Reality or speculations? PLoS One. 2020; 15(12): e0242024. PubMed Abstract | Publisher Full Text | Free Full Text

[19] 19. Cover J, Namagembe A, Morozoff C, et al.: Contraceptive self-injection through routine service delivery: Experiences of Ugandan women in the public health system. Front. Glob. Womens Health. 2022; 3: 911107. PubMed Abstract | Publisher Full Text | Free Full Text

[20] 20. Bapayeva G, Aimagambetova G, Issanov A, et al.: The effect of stress, anxiety and depression on in vitro fertilization outcome in kazakhstani public clinical setting: a cross-sectional study. J. Clin. Med. 2021; 10(5): 937. PubMed Abstract | Publisher Full Text | Free Full Text

[21] 21. De Boer ML, Bondevik H, Solbraekke KN: Beyond pathology: women’s lived experiences of melancholy and mourning in infertility treatment. Med. Humanit. 2020; 46(3): 214–225. PubMed Abstract | Publisher Full Text | Free Full Text

[22] 22. Simionescu G, Doroftei B, Maftei R, et al.: The complex relationship between infertility and psychological distress. Exp. Ther. Med. 2021; 21(4): 1.

[23] 23. Maroufizadeh S, Navid B, Omani-Samani R, et al.: The effects of depression, anxiety and stress symptoms on the clinical pregnancy rate in women undergoing IVF treatment. BMC. Res. Notes. 2019; 12(1): 1–4.

[24] 24. Söderlund J, Simonsen J, Alanko K, et al.: Tweens: A Positive Psychology Family Intervention for Adolescents with Depression-or Anxiety-related Symptomatology. Int. J. Appl. Posit. Psychol. 2023; 1–27. Publisher Full Text

[25] 25. Kamusheva M, Ignatova D, Golda A, et al.: The potential role of the pharmacist in supporting patients with depression–a literature-based point of view. Integr. Pharm. Res. Pract. 2020; 9: 49–63. PubMed Abstract | Publisher Full Text | Free Full Text

[26] 26. Galozy A, Nowaczyk S, Sant’Anna A, et al.: Pitfalls of medication adherence approximation through EHR and pharmacy records: definitions, data and computation. Int. J. Med. Inform. 2020; 136: 104092. PubMed Abstract | Publisher Full Text

[27] 27. Weidmann AE, Hoppel M, Deibl S: “It is the future. Clinical pharmaceutical care simply has to be a matter of course.”-Community pharmacy clinical service providers’ and service developers’ views on complex implementation factors. Res. Soc. Adm. Pharm. 2022; 18(12): 4112–4123. PubMed Abstract | Publisher Full Text

[28] 28. Ilardo ML, Speciale A: The community pharmacist: perceived barriers and patient-centered care communication. Int. J. Environ. Res. Public Health. 2020; 17(2): 536. PubMed Abstract | Publisher Full Text | Free Full Text

[29] 29. Namiq HS, Obeid KA, Mohammed DA: Role of pharmaceutical care in type 2 diabetic patients in kirkuk city. Al Mustansiriyah Journal of Pharmaceutical Sciences. 2020; 20(4): 169–181. Publisher Full Text

[30] 30. Chillab RZ, Al-Sabbagh M, Fakhri H: Evaluation of pharmaceutical care application in Iraqi hospital. Al Mustansiriyah Journal of Pharmaceutical Sciences. 2009; 6(1): 18–31. Publisher Full Text

[31] 31. El-Feshawy NI, Zromba AM, El-Ansary E-S: Effect of Collaborative Infertility Counseling on Coping Strategies and Marital Satisfaction among Women Undergoing in vitro Fertilization a Randomized Control Trial. Assiut Scientific Nurs. J. 2023; 11(37): 1–13.

[32] 32. Lee E, Han Y, Cha YJ, et al.: Community-based multi-site randomized controlled trial of behavioral activation for patients with depressive disorders. Community Ment. Health J. 2022; 1–13.

[33] 33. Fernandez-Ferrera C, Llaneza-Suarez D, Fernandez-Garcia D, et al.: Resilience, perceived stress, and depressed mood in women under in vitro fertilization treatment. Reprod. Sci. 2022; 29(3): 816–822. PubMed Abstract | Publisher Full Text | Free Full Text

[34] 34. Gabnai-Nagy E, Bugán A, Bodnár B, et al.: Association between emotional state changes in infertile couples and outcome of fertility treatment. Geburtshilfe Frauenheilkd. 2020; 80(02): 200–210. Publisher Full Text

[35] 35. Geoffrion R, Koenig NA, Zheng M, et al.: Preoperative depression and anxiety impact on inpatient surgery outcomes: a prospective cohort study. Ann. Surg. Open. 2021; 2(1): e049. PubMed Abstract | Publisher Full Text | Free Full Text

[36] 36. Ibrahim AA: CONSORT flow diagram for The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial.2023. Publisher Full Text

[37] 37. Booth HP, Charlton J, Gulliford MC: Socioeconomic inequality in morbid obesity with body mass index more than 40 kg/m2 in the United States and England. SSM Popul. Health. 2017; 3: 172–178. PubMed Abstract | Publisher Full Text | Free Full Text

[38] 38. Van Dam NT, Earleywine M: Validation of the Center for Epidemiologic Studies Depression Scale—Revised (CESD-R): Pragmatic depression assessment in the general population. Psychiatry Res. 2011; 186(1): 128–132. PubMed Abstract | Publisher Full Text

[39] 39. Boivin J, Takefman J, Braverman A: The fertility quality of life (FertiQoL) tool: development and general psychometric properties. Hum. Reprod. 2011; 26(8): 2084–2091. PubMed Abstract | Publisher Full Text | Free Full Text

[40] 40. Bach M: Psychosocial interventions for individuals with infertility.2018.

[41] 41. Kremer F, Ditzen B, Wischmann T: Effectiveness of psychosocial interventions for infertile women: A systematic review and meta-analysis with a focus on a method-critical evaluation. PLoS One. 2023; 18(2): e0282065. PubMed Abstract | Publisher Full Text | Free Full Text

[42] 42. Ha J-Y, Park H-J, Ban S-H: Efficacy of psychosocial interventions for pregnancy rates of infertile women undergoing in vitro fertilization: a systematic review and meta-analysis. J. Psychosom. Obstet. Gynecol. 2023; 44(1): 2142777. PubMed Abstract | Publisher Full Text

[43] 43. Katole A, Saoji AV: Prevalence of Primary Infertility and its Associated Risk Factors in Urban Population of Central India: A Community-Based Cross-Sectional Study. Indian J. Community Med. 2019; 44(4): 337–341. PubMed Abstract | Publisher Full Text | Free Full Text

[44] 44. Lewinsohn PM, Seeley JR, Roberts RE, et al.: Center for Epidemiologic Studies Depression Scale (CES-D) as a screening instrument for depression among community-residing older adults. Psychol. Aging. 1997; 12(2): 277–287. PubMed Abstract | Publisher Full Text

[45] 45. Irwin M, Artin KH, Oxman MN: Screening for depression in the older adult: criterion validity of the 10-item Center for Epidemiological Studies Depression Scale (CES-D). Arch. Intern. Med. 1999; 159(15): 1701–1704. Publisher Full Text

[46] 46. Greil AL, Slauson-Blevins K, McQuillan J: The experience of infertility: a review of recent literature. Sociol. Health Illn. 2010; 32(1): 140–162. Publisher Full Text

[47] 47. Rooney KL, Domar AD: The relationship between stress and infertility. JDicn. 2022.

[48] 48. Moeenizadeh M, Zarif H: The efficacy of well-being therapy for depression in infertile women. Int. J. Fertil. Steril. 2017; 10(4): 363–370. PubMed Abstract

[49] 49. Gardi AHH, Mohammed SH: Assessment of Psychological status of Infertile Women in Erbil Kurdistan Region. kufa Journal for Nursing sciences. 2013; 3(1): 149–160. Publisher Full Text

[50] 50. Malhotra N, Bahadur A, Singh N, et al.: Does obesity compromise ovarian reserve markers? A clinician’s perspective. Arch. Gynecol. Obstet. 2013; 287: 161–166. PubMed Abstract | Publisher Full Text

[51] 51. Yoo JH, Cha SH, Park CW, et al.: Comparison of mild ovarian stimulation with conventional ovarian stimulation in poor responders. Clin. Exp. Reprod. Med. 2011; 38(3): 159–163. PubMed Abstract | Publisher Full Text | Free Full Text

[52] 52. Chiaffarino F, Baldini MP, Scarduelli C, et al.: Prevalence and incidence of depressive and anxious symptoms in couples undergoing assisted reproductive treatment in an Italian infertility department. Eur. J. Obstet. Gynecol. Reprod. Biol. 2011; 158(2): 235–241. Publisher Full Text

[53] 53. Song D, Li X, Yang M, et al.: Fertility quality of life (FertiQoL) among Chinese women undergoing frozen embryo transfer. BMC Womens Health. 2021; 21(1): 1–7. Publisher Full Text

[54] 54. Suleimenova M, Lokshin V, Glushkova N, et al.: Quality-of-Life Assessment of Women Undergoing in vitro Fertilization in Kazakhstan. Int. J. Environ. Res. Public Health. 2022; 19(20): 13568. PubMed Abstract | Publisher Full Text | Free Full Text

[55] 55. Madero S, Gameiro S, García D, et al.: Quality of life, anxiety and depression of German, Italian and French couples undergoing cross-border oocyte donation in Spain. Hum. Reprod. 2017; 32(9): 1862–1870. PubMed Abstract | Publisher Full Text

[56] 56. Wdowiak A, Anusiewicz A, Bakalczuk G, et al.: Assessment of quality of life in infertility treated women in Poland. Int. J. Environ. Res. Public Health. 2021; 18(8): 4275. PubMed Abstract | Publisher Full Text | Free Full Text

[57] 57. Hsu P-Y, Lin M-W, Hwang J-L, et al.: The fertility quality of life (FertiQoL) questionnaire in Taiwanese infertile couples. Taiwan. J. Obstet. Gynecol. 2013; 52(2): 204–209. PubMed Abstract | Publisher Full Text

[58] 58. Golshani F, Mirghafourvand M, Hasanpour S, et al.: The effect of cognitive behavioral therapy on anxiety and depression in Iranian infertile women: a systematic and meta-analytical review. Iran. J. Psychiatry Behav. Sci. 2020; 14(1). Publisher Full Text

[59] 59. Shirin A, Atefeh A, Mahlegha D, et al.: The effect of cognitive behavior therapy on attitude of infertile individuals toward child adoption. J. Prev. Med. Hyg. 2022; 63(1): E97–E103. PubMed Abstract | Publisher Full Text

[60] 60. Faramarzi M, Alipor A, Esmaelzadeh S, et al.: Treatment of depression and anxiety in infertile women: cognitive behavioral therapy versus fluoxetine. J. Affect. Disord. 2008; 108(1-2): 159–164. Publisher Full Text

[61] 61. Rooney KL, Domar AD: The relationship between stress and infertility. Dialogues Clin. Neurosci. 2022.

[62] 62. Gorayeb R, Borsari ACT, Rosa-e-Silva ACJS, et al.: Brief cognitive behavioral intervention in groups in a Brazilian assisted reproduction program. Behav. Med. 2012; 38(2): 29–35. PubMed Abstract | Publisher Full Text

[63] 63. Li J, Long L, Liu Y, et al.: Effects of a mindfulness-based intervention on fertility quality of life and pregnancy rates among women subjected to first in vitro fertilization treatment. Behav. Res. Ther. 2016; 77: 96–104. PubMed Abstract | Publisher Full Text

[64] 64. Ibrahim AA: The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial.2023. Publisher Full Text

[65] 65. Ibrahim AA: Trial protocol for the assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial.2023. Publisher Full Text

[66] 66. Ibrahim AA: CONSORT Checklist for The assessment of educational and supportive care to the infertile females undergoes in vitro Fertilization procedure by clinical pharmacist: A Randomized Clinical Trial.2023. Publisher Full Text

The assessment of educational and supportive care to the infertile females undergoes In Vitro Fertilization procedure by clinical pharmacist: a randomized clinical trial

Abstract

Background

Method

Results

Conclusion

Trial registration

Keywords

Introduction

Method

Trial registration

Ethics

Study design

Figure 1. CONSORT flow diagram.36

Study setting

Inclusion criteria

Exclusion criteria

Variables

Educational program

Randomization

Sample size

Statistical analysis

Results

Table 1. Participants’ baseline data (n = 150).

Table 2. The distribution of patients' characteristics based on their assigned study groups.

Table 3. A comparison of FertiQoL score averages between the research groups.

Figure 2. At-risk participants evaluated for depression.

Table 4. Time-dependent association between study groups and the risk of developing depression.

Table 5. Relationship between pregnancy prognosis and the groups being studied.

Table 6. Time-dependent variances in FertiQoL scores mean per study group and pregnancy outcome.

Table 7. Time-dependent variances in FertiQoL scores mean per study group and pregnancy outcome.

Discussion

Study limitations

Conclusion

Data availability

Underlying data

Extended data

Reporting guidelines

Acknowledgment

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Browse by related subjects

Competing Interests Policy

Stay Updated

Figure 1. CONSORT flow diagram.³⁶