Endometriosis
Conditions
Keywords
endometriosis, medical therapy, ovarian reserve
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.
Interventions
None listed
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Follicle stimulating hormone (FSH) | Through study completion, an average of 4 years | Quantification of follicle stimulating hormone (FSH) levels |
| 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 |
Countries
Italy
Outcome results
None listed