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Completed

NCT Number: NCT06799754

Ovarian Reserve Following Medical Therapy in Patients With Endometriosis

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ovarian reserve in patients with ovarian endometriosis

    Time frame: 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 outcomes

  1. Follicle stimulating hormone (FSH)

    Time frame: Through study completion, an average of 4 years

    Quantification of follicle stimulating hormone (FSH) levels

  2. Ultrasound assessment of ovarian volume and endometriosis cyst volume

    Time frame: Through study completion, an average of 4 years

    Ultrasound assessment of ovarian volume and endometriosis cyst volume

  3. Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone

    Time frame: 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

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Evaluation Of The Change In Ovarian Reserve Following Medical Therapy In Patients With Endometriosis

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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