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

Not Applicable

Completed

• Conditions: Ovarian Endometrioma
• Interventions: Procedure: Diode laser coagulation; Procedure: Bipolar coagulation

• Registration Number: NCT02350452
• Lead Sponsor: University of Cagliari

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-25
• Study First Posted: 2015-01-29
• Primary Completion: 2015-08
• Study Completion: 2016-02
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diode laser coagulation	Diode laser coagulation	Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Bipolar coaugulation	Bipolar coagulation	Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Primary Outcome Measures

Name	Time	Method
Anti-Müllerian hormone (AMH) serum levels	Change from AMH serum levels at 3 months after surgery

Secondary Outcome Measures

Name	Time	Method
Antral follicular count (AFC)	Change from AFC at 3 months after surgery, during early follicular phase

Trial Locations

Locations (1)

University of Cagliari,Obstetrics and Gynecological Department,; 🇮🇹 Monserrato, Cagliari, Italy