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

University of Cagliari

Status: Completed

Conditions: Ovarian Endometrioma

Treatments: Procedure: Bipolar coagulation; Procedure: Diode laser coagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02350452

ENDOLASER01

Details and patient eligibility

About

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 .

Enrollment: 50 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Diode laser coagulation

Experimental group

Description:

Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Treatment:

Procedure: Diode laser coagulation

Bipolar coaugulation

Active Comparator group

Description:

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Treatment:

Procedure: Bipolar coagulation