Clinical trial NCT06799754: Ovarian Reserve Following Medical Therapy in Patients With Endometriosis
Official title: Evaluation Of The Change In Ovarian Reserve Following Medical Therapy In Patients With Endometriosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Keywords: endometriosis
medical therapy
ovarian reserve
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with ovarian endometriosis desiring pregnancy with or without concomitant deep endometriosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ovarian reserve in patients with ovarian endometriosis
timeFrame: Through study completion, an average of 4 years
Secondary outcomes:
measure: Follicle stimulating hormone (FSH)
timeFrame: Through study completion, an average of 4 years
measure: Ultrasound assessment of ovarian volume and endometriosis cyst volume
timeFrame: Through study completion, an average of 4 years
measure: Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone
timeFrame: Through study completion, an average of 4 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Renato Seracchioli, MD
role: PRINCIPAL_INVESTIGATOR
References: