The role of transvaginal sonography in diagnosis of female infertility: a study protocol

Nirja Thaker; Rajasbala Dhande

doi:10.12688/f1000research.140962.1

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The role of transvaginal sonography in diagnosis of female infertility: a study protocol

[version 1; peer review: 1 not approved]

Nirja Thaker ¹, Rajasbala Dhande¹

PUBLISHED 16 Oct 2023

Author details Author details

¹ Department of Radio-diagnosis, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Nirja Thaker
Roles: Writing – Original Draft Preparation

Rajasbala Dhande
Roles: Supervision, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Infertility has an increased incidence in today’s world. It has a negative impact on both the psychological and physical aspects of a person. In order to tackle this issue, it is necessary to know the cause of infertility. Transvaginal ultrasound is an accurate, cost-effective and rapid method in diagnosing the causes of infertility which can reduce the need of invasive procedures like hysteroscopy. The main aim of this study is to describe the role of transvaginal ultrasonography in diagnosing various causes of female infertility.

Keywords

INFERTILITY, TRANSVAGINAL ULTRASONOGRAPHY, DIAGNOSIS

Corresponding author: Nirja Thaker

Competing interests: No competing interests were disclosed.

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

Copyright: © 2023 Thaker N and Dhande R. 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: Thaker N and Dhande R. The role of transvaginal sonography in diagnosis of female infertility: a study protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:1335 (https://doi.org/10.12688/f1000research.140962.1) First published: 16 Oct 2023, 12:1335 (https://doi.org/10.12688/f1000research.140962.1) Latest published: 30 Jul 2025, 12:1335 (https://doi.org/10.12688/f1000research.140962.2)

Introduction

Infertility is the inability to conceive after one year of unprotected intercourse. Approximately 15.5% of women globally are afflicted with infertility.¹ In India, the prevalence ranges from 3.9 to 16.8% (according to the Government website). The standard workup for female infertility includes assessing ovarian reserve, tubal and uterine examination, hormonal issues such as thyroid disorders and prolactin abnormalities, and confirmation of polycystic ovarian syndrome/disorder (PCOS).²

Female infertility causes are difficult to pinpoint. Although there are numerous therapies available, the treatment will be determined on the basis of cause of infertility. The most significant gains in assisted reproductive technology (ART) have resulted from advancements in pelvic structure evaluation tools.³ Infertility evaluation necessitates histo-pathological testing as well as visualization using several imaging modalities. There are many causes of infertility, including ovarian (such as ovarian dysgenesis or agenesis, premature ovarian failure, oophoritis, chocolate cyst, and polycystic ovarian syndrome), uterine (such as fibroid, adenomyosis, mullerian duct anomalies, endometrial polyp, endometriosis, endometritis, and intra-uterine adhesions caused by infectious causes such as tuberculosis), cervical aetiology (such as cervical stenosis), tubal aetiology (such as tubal occlusion, hydrosalpinx, pelvic inflammatory illness, and endometriosis).⁴

Because it is inexpensive, convenient, and gives basic information about the morphology of the uterus, cervix, endometrium, adnexa, and ovaries, ultrasound is the chosen initial modality of study for evaluating possible causes of female infertility.⁵

Transvaginal ultrasonography (TVS) is a relatively new diagnostic method for the female pelvic region. A high frequency transducer is implanted endo-vaginally to evaluate pelvic organs in detail. But other investigations are needed to confirm TVS's role and to know how accurate it is in diagnosing various causes of primary and secondary infertility.⁵

Rationale

Infertility has a negative physical and psychological impact on the individual, and the causes can be difficult to identify. Although there are numerous therapies available, the treatment of choice will be determined by the cause of infertility. Transvaginal ultrasonography is a relatively new diagnostic method for the female pelvic region. It is a low-cost, rapid, safe (no ionising radiation), and precise technique for determining the reasons of various gynecological problems. The goal of this study is to re-evaluate the role of TVS in diagnosing various causes of infertility. It reduces the need for invasive diagnostic procedures such as hysteroscopy.

Research question

What are the common causes of infertility and its various imaging findings when diagnosed with transvaginal ultrasound?

Aim

The aim of this study is to describe the role of transvaginal ultrasonography in diagnosing various causes of female infertility.

Objectives

1. To describe the role of transvaginal ultrasonography in evaluating various adnexal, uterine and cervical pathologies as a cause of female infertility.
2. To find the ovarian causes of infertility by measuring the ovarian volume, follicular size, and ovarian reserve assessment in form of antral follicular count.
3. To compare the accuracy in diagnosis of female infertility by TVS in comparison with other diagnostic modalities like hysteroscopy, MRI, histopathology etc. wherever possible.

Protocol

The institute will begin data collection after the project has been ethically cleared.

Once a patient passes the eligibility requirements for the study, the process will be described to them and written agreement will be obtained.

A female attendant/nurse will be present throughout the process.

Proper sanitary conditions will be maintained – Gloves will be worn by the health professionals, and a condom will be used to cover the transvaginal probe.

Before the scan, the patient will be instructed to empty her bladder, and she will be scanned in the lithotomy position. TVS is performed with a 5-12 MHz endovaginal probe on ALOKA HITACHI ARIETTA S-70 and WIPRO GE LOGIQ P5 PRO ultrasound equipment during the follicular phase of the menstrual cycle (the 5th-13th day following menstruation).

The TVS probe will be first covered with ultrasound gel, then with a condom, and finally with ultrasound gel again over the covered transducer. A female nurse will inject it inside the patient.

The uterus will be examined in both saggital and transverse views to examine the entire uterine anatomy, including the cervix, ovaries, adnexa, myometrium, and endometrium (thickness and consistency). The measurement of uterine dimensions (length and height) is taken in the saggital plane, whereas the width is assessed in the transverse plane (at the level of the tubal ostia). The mid-saggital plane is used to evaluate endometrial thickness. Ovarian length, height, and width will be measured, as well as the baseline AFC (antral follicle count of follicles measuring 2-10mm and >10mm).⁶ AFC is calculated by adding the total follicles of both ovaries (AFC5 is regarded low, AFC>=20 is called ovarian hyperstimulation syndrome, and AFC=4 indicates a chance of menopause within the next 7 years).⁷^–⁹

Free fluid and sliding sign (to see adhesion) are seen in examination of the culdesac- This involves applying gentle pressure through probe on the lower abdomen to assess the gliding of anterior rectum and sigmoid colon along the posterior aspect of the upper portion of uterus, cervix, and vaginal wall. When sliding sign is “Negative”, it indicates the obliteration of pouch of Douglas which can be due to endometriosis.

Thus data will be collected regarding the various causes of infertility relating to adnexal, uterine and cervical pathologies, and ovarian causes (by measuring the ovarian volume, follicular size, and ovarian reserve assessment in form of antral follicular count). Also data regarding causes of infertility will be collected from different modalities like Magnetic resonance imaging of pelvis and hysterosalpingography and results of other modalitity will be compared with results from transvaginal ultrasound.

As this is mainly a descriptive study, the data(causes) will be enumerated in a tabular form. And wherever possible accuracy of transvaginal sonography in diagnosing infertility will be mentioned in percentage (as compared to different modalities).

Consent

A written consent will be obtained in either Marathi or English from all the patients included in this study.

Ethical approval

Ethical approval was obtained from the Institutional Ethics Committee (Datta Meghe Institute Of Higher Education And Research) Re-regd. No.: ECR/440/Inst/MH/2013/RR-2019)-Dated- 21/03/2023.

Methods

Study design

This study will be a descriptive prospective cross-sectional study conducted on patients visiting the OPD department as well as the IPD patients of Hospital from January 2023 to January 2025. The population will consist of married women in the age group of 18-40 years with the inability to conceive for one year despite being sexually active, who present to the gynecology department.

We will use purposive sampling to recruit the participants.

Sample size:

Formula with prevalence with proportion

Topic: female infertility.

Prevalence= 3.9 to 16.6% (average -10.25%) (website)

Formula

α: type I error = 0.05

Estimated proportion (p) = 0.10

Estimation of error (d) = 0.05

n > = {Z^{2}}_{1 - α / 2} x p (1 - p) / d^{2}

Minimum sample size needed = 139

Duration of study: 2023 – 2025

Inclusion criteria

▪ All married female patients between the ages of 18 and 40 who present to ABVRH with a provisional clinical diagnosis of infertility (including primary and secondary).

Exclusion criteria

• Female patients under the age of 18.
• Female patients above the age of 40.
• Married female patients who refuse to give consent.
• Married female patients with suspected infertility caused by medication, radiation, or pituitary, adrenal, or thyroid gland issues.
• Female patients who are married and have a uterine congenital abnormality.

Study Status:

Recruitment.

Discussion

A study ‘Role of transvaginal ultrasonography and diagnostic hysteroscopy in assessing endometrial cavity of women presenting with infertility’ was conducted by K. Sarala et al. in 2018. This study concluded that hysteroscopy can be regarded as the gold standard in the diagnosis of infertility. The study compared the transvaginal findings with hysteroscopic findings. The transvaginal findings and hysteroscopic findings were similar. The various causes of infertility were endometrial hyperplasia, submucous fibroids, endometrial polyps, adhesions and congenital malformations in decreasing order of frequency respectively. Thus it was concluded that although hysteroscopy is considered gold-standard, transvaginal sonography can be used as an initial investigation in the infertility work.¹⁰

In the study conducted by Maysa S. Elkerdawy et al. on role of ultra-sonography (USG) in management of primary infertility, it was found that 60% of patients had uterine abnormalities (mainly subseptate and bicornuate uterus) while approximately 23% of patients had ovarian pathology (mainly polycystic ovaries). Only a small percentage of patients had tubal and cervical pathologies (like hydrosalpinx, cervical mass etc.). It was further found that USG can be used as a primary tool for investigation.⁴

In the study carried out by Salaam AJ et al. on the topic of evaluation of infertile women using transvaginal USG, primary fertility constituted about 42% of total subjects while secondary infertility constituted about 58%, and about 54% had normal TVS findings and rest (46%) had abnormal findings like uterine fibroid, free fluid in Pouch of Douglas (POD), endometritis, and hydrosalpinx in the decreasing order of frequency. It was also found that there was a significant difference in volume between the right and left ovaries in infertile women with Polycystic ovaries (PCO). This study found that a high yield of sonographic anomalies were observed on transvaginal sonography in infertile subjects, bolstering TVS's essential function as a useful diagnostic tool for evaluating infertility.¹¹

In the study conducted on transvaginal sonographical findings by Nafeesa Binti Hussain et al. on women presenting with inability to conceive, they inferred the following: 75%of cases were of primary infertility while 25% of cases were of secondary infertility, and the most common pathological findings were polycystic ovarian syndrome (69%), followed by chronic pelvic inflammatory disorder, fibroid, anatomical disorders, endometrial or cervical polyps, and endometritis in decreasing order of frequency. The study concluded that PCO was the most frequent finding in women with infertility, which was easily diagnosed by transvaginal sonography.⁵

Scope

Transvaginal ultrasonography is a highly accurate method for detecting various disorders in the female reproductive system. The goal of this study is to identify the many diseases of primary and secondary infertility and to demonstrate the diagnostic accuracy of TVS as a main inquiry in infertility.

Dissemination

This study will enumerate the various causes of infertility in today’s scenario in India that will be educational and helpful in future planning of focus areas for further studies. This study will establish the importance of Transvaginal sonography as a first line in diagnosis of infertility.

Data availability

No data are associated with this article.

References

1. Expert Panel on Women’s ImagingWall DJ, Reinhold C, et al.: ACR Appropriateness Criteria® Female Infertility. J. Am. Coll. Radiol. 2020 May; 17(5S): S113–S124. PubMed Abstract | Publisher Full Text
2. Kondagari L, Kahn J, Singh M; Sonography Gynecology Infertility Assessment, Protocols, And Interpretation.
3. Aflatoonian A, Mashayekhy M: Transvaginal Ultrasonography in Female Infertility Evaluation.
4. Elkerdawy MS, Ali MA, Nermeen N: Keriakos, Ultrasound Role in Management of Female Infertility, 1523-1530.2020.
5. Hussain NB, Das RR: Transvaginal Ultrasound Findings Among the Women Presenting with Infertility.2017.
6. AIUM Practice Parameter for the Performance of a Focused Ultrasound Examination in Reproductive Endocrinology and Female Infertility. J. Ultrasound Med. 2019 Mar; 38(3): E1E3. PubMed Abstract | Publisher Full Text
7. Coelho Neto MA, Ludwin A, Borrell A, et al.: Counting ovarian antral follicles by ultrasound: a practical guide. Ultrasound Obstet. Gynecol. 2018 Jan; 51(1): 10–20. PubMed Abstract | Publisher Full Text
8. Depmann M, Broer SL, van der Schouw YT , et al.: Can we predict age at natural menopause using ovarian reserve tests or mother's age at menopause? A systematic literature review. Menopause. 2016 Feb; 23(2): 224–232. PubMed Abstract | Publisher Full Text
9. Wellons MF, Bates GW, Schreiner PJ, et al.: Antral follicle count predicts natural menopause in a population-based sample: the Coronary Artery Risk Development in Young Adults Women's Study. Menopause. 2013 Aug; 20(8): 825–830. PubMed Abstract | Publisher Full Text | Free Full Text
10. Sarala K, Misra K: Role of Transvaginal Sonography and Diagnostic Hysteroscopy in Evaluation of Endometrial Cavity in Infertile Women.2018.
11. Kolade-Yunusa HO, Abdullahi HI, Salaam AJ: Evaluation of infertile women using transvaginal ultrasound in a tertiary health facility.2019.

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Version 2

VERSION 2 PUBLISHED 16 Oct 2023

Author details Author details

¹ Department of Radio-diagnosis, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, 442001, India

Nirja Thaker
Roles: Writing – Original Draft Preparation

Rajasbala Dhande
Roles: Supervision, 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 (2)

version 2

Revised

Published: 30 Jul 2025, 12:1335

https://doi.org/10.12688/f1000research.140962.2

version 1

Published: 16 Oct 2023, 12:1335

https://doi.org/10.12688/f1000research.140962.1

Copyright

© 2023 Thaker N and Dhande R. 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.

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Thaker N and Dhande R. The role of transvaginal sonography in diagnosis of female infertility: a study protocol [version 1; peer review: 1 not approved]. F1000Research 2023, 12:1335 (https://doi.org/10.12688/f1000research.140962.1)

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Reviewer Report 30 Nov 2023

Elias Tsakos, EmbryoClinic IVF, Thessaloniki, Greece

Emmanouil Xydias, EmbryoClinic IVF, Thessaloniki, Greece

Not Approved

https://doi.org/10.5256/f1000research.154371.r223667

This is a protocol for a prospective, cross-sectional study with the reported aim of assessing the role of transvaginal ultrasound in the diagnosis of female infertility. I unfortunately have located several issues with the proposed protocol, which I will divide ... Continue reading

This is a protocol for a prospective, cross-sectional study with the reported aim of assessing the role of transvaginal ultrasound in the diagnosis of female infertility. I unfortunately have located several issues with the proposed protocol, which I will divide into subcategories.

Background/introduction: The breakdown of infertility and the causes is quite adequate. However, I find issue with the description of the role of transvaginal ultrasound (TVUS) as a relatively new method of assessment. TVUS is by no means a new method, but a well-established diagnostic tool, which has become an indispensable part of gynecological examination and its value has been already demonstrated repeatedly by many published studies.
Rationale: Once more, the value of TVUS in the assessment of pelvic anatomy is well-known and has been described long ago, take for instance the articles by Gratton et al¹, which describes the assessment of normal pelvic anatomy via the use of TVUS over 30 years ago. Likewise, its value in the infertile patient has also been demonstrated long ago and repeatedly, for example by Ubaldi et al. in 1998². Overall, your rationale, in my opinion, does not demonstrate a gap in medical knowledge, or a lack of sufficient data in order to justify this research (at least in its present form, see also “research question”).
Research question: This is the most problematic part of this protocol in my opinion. The research question is very broad and vague. The “role” is not a quantifiable outcome, to use, it is a subjective metric. Outcomes such as diagnostic accuracy, cost, safety, tolerability, diagnostic efficacy compared to alternative diagnostic methods, complications, reproducibility of results, values of ultrasonographic measurements etc are more appropriate for medical research, as they evaluate specific aspects of the performance of this diagnostic method (continued in the next point).
In your “Objectives”, the most important section of the research protocol, you introduce the potential of comparing to other methods (point 3), but again, this is too vague, it is not clear which specific methods will be used and whether they will apply to all patients. In point 2 of the “Objectives”, you also introduce the interesting potential of specific measurements, however, you do not explain what is to be done with these measurements. Will they be compared to a health control? Will they be utilized as prognosis factors of fertility, based on whether the woman achieves pregnancy? Simple collection and presentation of data does not suffice, analysis and evidence-based interpretation is necessary.
Related to the above, you need to define your research question and your outcomes/objectives more clearly and using quantifiable measures. I suggest using the PICO format, or one of its alternatives³.
Sample size: the website you cite demonstrated that the average rate of infertility was 12.6 per cent (n = 113; 95% CI: 10.5-15.0%), so you should use this percentage, unless there were other sources as well. Additionally, please provide the statistical software that you used to conduct the sample size calculation.
In your exclusion criteria, since you wish to assess female fertility only, you should exclude cases of male factor infertility as well. Therefore, some screening of the husbands’ reproductive health may also be necessary to achieve homogeneity.
In your “Scope”, you introduce the additional, different objective of quantifying the various causes of infertility, thus introducing an epidemiological surveillance angle. Right after that, you mention that the goal is also to demonstrate the diagnostic accuracy of TVUS. However, diagnostic accuracy studies require a reference standard in order to determine sensitivity, specificity and other parameters, which is something not mentioned in your protocol.
References: most references are not accessible, please provide links or DOI.

Overall, if I had to summarize my recommendations, they would be to apply a narrower focus on your research question. Define specific, quantifiable outcomes and use comparators when and if necessary. If diagnostic accuracy is the outcome, then a reference standard, such as hysteroscopy will be required. Even if your ultimate aim is to simply collect and present epidemiological data, confirmation of the diagnoses made by ultrasound will be required by a reference standard. Additionally, infertility is frequently caused by multiple factors, so you will need to address that as well. In any case, major revision are required.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

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

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Gratton D, Harrington C, Holt S, Lyons E: Normal Pelvic Anatomy Using Transvaginal Scanning. Obstetrics and Gynecology Clinics of North America. 1991; 18 (4): 693-711 Publisher Full Text
2. Ubaldi F, Wisanto A, Camus M, Tournaye H, et al.: The role of transvaginal ultrasonography in the detection of pelvic pathologies in the infertility workup.Hum Reprod. 1998; 13 (2): 330-3 PubMed Abstract | Publisher Full Text
3. Aslam S, Emmanuel P: Formulating a researchable question: A critical step for facilitating good clinical research.Indian J Sex Transm Dis AIDS. 2010; 31 (1): 47-50 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Obstetrics & Gynaecology, Fertility, Gynaecological Surgery, Robotic Surgery, Minimally Invasive Surgery

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

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Version 2 (revision) 30 Jul 25		read
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Elias Tsakos, EmbryoClinic IVF, Thessaloniki, Greece

Emmanouil Xydias, EmbryoClinic IVF, Thessaloniki, Greece
Halima Al Balushi, Sultan Qaboos University, Seeb, Oman

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10 Sep 2025 | for Version 2

Halima Al Balushi, Sultan Qaboos University, Seeb, Oman

2 Views Cite this report Responses(0)

Not Approved

This study addresses an important clinical question regarding the diagnostic role of transvaginal ultrasonography in female infertility. The topic is highly relevant, given the need for less invasive, cost-effective, and widely available diagnostic methods in infertility workups. However, the current proposal suffers from issues related to scope, outcome clarity, comparator heterogeneity, and methodological rigor. In particular, the lack of distinction between diagnostic and clinical outcomes, limited follow-up period, and potential underpowering of sub-analyses are significant concerns. These limitations should be addressed to ensure the study produces clinically meaningful and generalizable findings.

Major Concerns
Overly broad scope
The study attempts to evaluate the role of TVUS in detecting ovarian, uterine, and tubal abnormalities, as well as its correlation with fertility outcomes. This breadth may limit feasibility, as sufficient sample size and statistical power will be required across multiple subgroups.

Narrowing the focus to the most clinically relevant or prevalent conditions could strengthen the design.

Ambiguity in outcomes
The manuscript presents diagnostic accuracy as the primary outcome, but also includes conception within six months as an endpoint. These represent different outcome categories (diagnostic vs. clinical).

Clear distinction between primary and secondary outcomes is necessary to avoid dilution of the study’s main objective.

Heterogeneous comparators
The comparators (HSG, laparoscopy, hormonal assays) evaluate different infertility factors. Without explicit clarification of which reference standard applies to which abnormality, results may be difficult to interpret. For instance, tubal factors should primarily be validated against HSG or laparoscopy, while ovarian function should be referenced against hormonal profiles.

Confounding from male infertility
Although male infertility is to be excluded via semen analysis, mild or borderline abnormalities may still affect fertility outcomes. This could confound the relationship between TVUS findings and conception rates.

A stricter exclusion protocol or sensitivity analysis may be warranted.

Clinical outcome follow-up
Limiting conception outcomes to six months may underestimate correlations, as many couples achieve conception beyond this timeframe even without intervention.

A longer follow-up period would improve the robustness of fertility outcome assessment.

Minor Concerns

Cost-effectiveness and patient acceptability
While diagnostic accuracy is central, real-world clinical adoption also depends on cost-effectiveness and patient comfort. The study could be strengthened by at least discussing these aspects.
Reproducibility of TVUS
While the study mentions assessing reproducibility, it does not specify whether intra-observer and inter-observer variability will be measured. These are critical in imaging studies and should be incorporated.
Age range limitations
Restricting the study population to women aged 20–40 may limit generalizability, especially as infertility is common in women over 40. This should be acknowledged as a limitation.
Power of sub-analyses
The planned comparison of TVUS with laparoscopy and HSG in a sub-cohort raises concerns about sample size adequacy. Underpowered subgroups may yield imprecise estimates of diagnostic accuracy.
Prevalence estimates
Reporting both prevalence of infertility causes and diagnostic performance from the same dataset could risk circular interpretation, particularly if TVUS misclassifications are not carefully adjusted against reference standards.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

reproductive medicine, regenerative mdeicine, fertility preservation, molecular biology

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.

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Reviewer Report

3 Views

30 Nov 2023 | for Version 1

Elias Tsakos, EmbryoClinic IVF, Thessaloniki, Greece

Emmanouil Xydias, EmbryoClinic IVF, Thessaloniki, Greece

3 Views Cite this report Responses(0)

Not Approved

This is a protocol for a prospective, cross-sectional study with the reported aim of assessing the role of transvaginal ultrasound in the diagnosis of female infertility. I unfortunately have located several issues with the proposed protocol, which I will divide into subcategories.

Background/introduction: The breakdown of infertility and the causes is quite adequate. However, I find issue with the description of the role of transvaginal ultrasound (TVUS) as a relatively new method of assessment. TVUS is by no means a new method, but a well-established diagnostic tool, which has become an indispensable part of gynecological examination and its value has been already demonstrated repeatedly by many published studies.
Rationale: Once more, the value of TVUS in the assessment of pelvic anatomy is well-known and has been described long ago, take for instance the articles by Gratton et al¹, which describes the assessment of normal pelvic anatomy via the use of TVUS over 30 years ago. Likewise, its value in the infertile patient has also been demonstrated long ago and repeatedly, for example by Ubaldi et al. in 1998². Overall, your rationale, in my opinion, does not demonstrate a gap in medical knowledge, or a lack of sufficient data in order to justify this research (at least in its present form, see also “research question”).
Research question: This is the most problematic part of this protocol in my opinion. The research question is very broad and vague. The “role” is not a quantifiable outcome, to use, it is a subjective metric. Outcomes such as diagnostic accuracy, cost, safety, tolerability, diagnostic efficacy compared to alternative diagnostic methods, complications, reproducibility of results, values of ultrasonographic measurements etc are more appropriate for medical research, as they evaluate specific aspects of the performance of this diagnostic method (continued in the next point).
In your “Objectives”, the most important section of the research protocol, you introduce the potential of comparing to other methods (point 3), but again, this is too vague, it is not clear which specific methods will be used and whether they will apply to all patients. In point 2 of the “Objectives”, you also introduce the interesting potential of specific measurements, however, you do not explain what is to be done with these measurements. Will they be compared to a health control? Will they be utilized as prognosis factors of fertility, based on whether the woman achieves pregnancy? Simple collection and presentation of data does not suffice, analysis and evidence-based interpretation is necessary.
Related to the above, you need to define your research question and your outcomes/objectives more clearly and using quantifiable measures. I suggest using the PICO format, or one of its alternatives³.
Sample size: the website you cite demonstrated that the average rate of infertility was 12.6 per cent (n = 113; 95% CI: 10.5-15.0%), so you should use this percentage, unless there were other sources as well. Additionally, please provide the statistical software that you used to conduct the sample size calculation.
In your exclusion criteria, since you wish to assess female fertility only, you should exclude cases of male factor infertility as well. Therefore, some screening of the husbands’ reproductive health may also be necessary to achieve homogeneity.
In your “Scope”, you introduce the additional, different objective of quantifying the various causes of infertility, thus introducing an epidemiological surveillance angle. Right after that, you mention that the goal is also to demonstrate the diagnostic accuracy of TVUS. However, diagnostic accuracy studies require a reference standard in order to determine sensitivity, specificity and other parameters, which is something not mentioned in your protocol.
References: most references are not accessible, please provide links or DOI.

Overall, if I had to summarize my recommendations, they would be to apply a narrower focus on your research question. Define specific, quantifiable outcomes and use comparators when and if necessary. If diagnostic accuracy is the outcome, then a reference standard, such as hysteroscopy will be required. Even if your ultimate aim is to simply collect and present epidemiological data, confirmation of the diagnoses made by ultrasound will be required by a reference standard. Additionally, infertility is frequently caused by multiple factors, so you will need to address that as well. In any case, major revision are required.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

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

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Gratton D, Harrington C, Holt S, Lyons E: Normal Pelvic Anatomy Using Transvaginal Scanning. Obstetrics and Gynecology Clinics of North America. 1991; 18 (4): 693-711 Publisher Full Text
2. Ubaldi F, Wisanto A, Camus M, Tournaye H, et al.: The role of transvaginal ultrasonography in the detection of pelvic pathologies in the infertility workup.Hum Reprod. 1998; 13 (2): 330-3 PubMed Abstract | Publisher Full Text
3. Aslam S, Emmanuel P: Formulating a researchable question: A critical step for facilitating good clinical research.Indian J Sex Transm Dis AIDS. 2010; 31 (1): 47-50 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Obstetrics & Gynaecology, Fertility, Gynaecological Surgery, Robotic Surgery, Minimally Invasive Surgery

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

Respond to this report

Responses (0)

[1] 1. Expert Panel on Women’s ImagingWall DJ, Reinhold C, et al.: ACR Appropriateness Criteria® Female Infertility. J. Am. Coll. Radiol. 2020 May; 17(5S): S113–S124. PubMed Abstract | Publisher Full Text

[2] 2. Kondagari L, Kahn J, Singh M; Sonography Gynecology Infertility Assessment, Protocols, And Interpretation.

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The role of transvaginal sonography in diagnosis of female infertility: a study protocol

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