Ovarian Reserve Following Medical Therapy in Patients with Endometriosis

Completed

• Conditions: Endometriosis

• Registration Number: NCT06799754
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Brief Summary

This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis.

Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve.

The aim of this study is to investigate whether there is a difference in ovarian reserve as measured by biochemical and ultrasound parameters before and after therapy.

Detailed Description

Endometriosis is a benign, chronic and recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis is most frequently localised to the ovary (17 - 44%) and is found in 5-10% of women of childbearing age. In this group of patients, quantification of the ovarian reserve by means of serological and ultrasound markers, in particular antral follicular count (AFC) and blood levels of antimullerian hormone (AMH), is essential. Recent evidence shows that medical hormone therapy, currently the first choice of treatment, affects ovarian endometriosis in terms of volumetric reduction of endometriomas and reduction of local inflammation, but little is known about its effect on ovarian reserve.

Our study therefore aims to evaluate ovarian reserve in terms of AMH and AFC in patients with ovarian endometriosis treated with medical hormone therapy after discontinuation of the latter.

In the clinical trial, patients diagnosed with ovarian endometriosis with an indication for medical therapy undergo 3 blood samples for the determination of antimullerian hormone (AMH) at the same time as 3 medical examinations as per normal care procedure.

Study Timeline

• Study Start: 2020-07-19
• Primary Completion: 2023-01-31
• Status Verified: 2024-11
• Study Completion: 2024-11-18
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Clinical and ultrasound diagnosis of ovarian endometriosis without indication for surgery
• Age between 18 and 40 years
• Patients desiring pregnancy
• Informed consent obtained

Exclusion Criteria

• Endocrinological disorders (including thyroid dysfunction, hyperprolactinaemia and Cushing's syndrome)
• Previous ovarian surgery
• Suspected cyst malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ovarian reserve in patients with ovarian endometriosis	Through study completion, an average of 4 years	Evaluate the ovarian reserve at ultrasound and biochemical level in patients with ovarian endometriosis treated with medical therapy

Secondary Outcome Measures

Name	Time	Method
Ultrasound assessment of ovarian volume and endometriosis cyst volume	Through study completion, an average of 4 years	Ultrasound assessment of ovarian volume and endometriosis cyst volume
Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone	Through study completion, an average of 4 years	Evaluation of a possible difference in ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone
Follicle stimulating hormone (FSH)	Through study completion, an average of 4 years	Quantification of follicle stimulating hormone (FSH) levels

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, Italy