[version 1; peer review: 1 not approved]
No competing interests were disclosed.
Infertility is the inability to conceive after one year of unprotected intercourse. Approximately 15.5% of women globally are afflicted with infertility.
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.
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.
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.
What are the common causes of infertility and its various imaging findings when diagnosed with transvaginal ultrasound?
The aim of this study is to describe the role of transvaginal ultrasonography in diagnosing various causes of female infertility.
To describe the role of transvaginal ultrasonography in evaluating various adnexal, uterine and cervical pathologies as a cause of female infertility. To find the ovarian causes of infertility by measuring the ovarian volume, follicular size, and ovarian reserve assessment in form of antral follicular count. To compare the accuracy in diagnosis of female infertility by TVS in comparison with other diagnostic modalities like hysteroscopy, MRI, histopathology etc. wherever possible.
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
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
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).
A written consent will be obtained in either Marathi or English from all the patients included in this study.
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.
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.
Formula with prevalence with proportion
Topic: female infertility.
Prevalence= 3.9 to 16.6% (average -10.25%) (
Formula
α: type I error = 0.05
Estimated proportion (p) = 0.10
Estimation of error (d) = 0.05
Minimum sample size needed =
Duration of study
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).
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:
A study ‘Role of transvaginal ultrasonography and diagnostic hysteroscopy in assessing endometrial cavity of women presenting with infertility’ was conducted by K. Sarala
In the study conducted by Maysa S. Elkerdawy
In the study carried out by Salaam AJ
In the study conducted on transvaginal sonographical findings by Nafeesa Binti Hussain
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
No data are associated with this article.
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 al
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 alternatives
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 study design appropriate for the research question?
No
Is the rationale for, and objectives of, the study clearly described?
Partly
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
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.