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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Ovarian reserve in patients with ovarian endometriosis | Evaluate the ovarian reserve at ultrasound and biochemical level in patients with ovarian endometriosis treated with medical therapy | Through study completion, an average of 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Follicle stimulating hormone (FSH) | Quantification of follicle stimulating hormone (FSH) levels | Through study completion, an average of 4 years |
| Ultrasound assessment of ovarian volume and endometriosis cyst volume |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with ovarian endometriosis desiring pregnancy with or without concomitant deep endometriosis
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| Name | Affiliation | Role |
|---|---|---|
| Renato Seracchioli, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Ultrasound assessment of ovarian volume and endometriosis cyst volume
| Through study completion, an average of 4 years |
| Ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone | Evaluation of a possible difference in ovarian reserve in patients with concomitant deep endometriosis compared to those with ovarian endometriosis alone | Through study completion, an average of 4 years |
| D000091662 | Genital Diseases |