Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas

Study Overview
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Brief Summary
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Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques. The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve. The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .

Official Title
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The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.

Conditions
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Ovarian Endometrioma

Intervention / Treatment
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* Procedure: Diode laser coagulation
* Procedure: Bipolar coagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: regular menstrual cycles unilateral endometrioma greater than 35 mm no gynecological surgery 3-6 months before surgery no hormonal therapy 1 month before surgery Exclusion Criteria: previous surgery for endometriosis hormone therapy in the month before the current surgery coagulation disorders ongoing pregnancy pelvic inflammatory disease malignant disorders cysts otherwise Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up BMI≥ 30 kg/m2 endocrinological disorders unable or unwilling to give written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diode laser coagulation<br>Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy | Procedure: Diode laser coagulation<br>* Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy<br>|
| Active Comparator: Bipolar coaugulation<br>Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy | Procedure: Bipolar coagulation<br>* Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-Müllerian hormone (AMH) serum levels |  | Change from AMH serum levels at 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antral follicular count (AFC) |  | Change from AFC at 3 months after surgery, during early follicular phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diode laser, laparoscopic surgery, AMH, AFC