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

NCT02350452 | Completed

• 1 other identifier: ENDOLASER01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 .

Conditions

Ovarian Endometrioma

Keywords

laparoscopic surgery; diode laser; AMH; AFC

Outcome Measures

Primary Outcomes (1)

• Anti-Müllerian hormone (AMH) serum levels

  Change from AMH serum levels at 3 months after surgery

Secondary Outcomes (1)

• Antral follicular count (AFC)

  Change from AFC at 3 months after surgery, during early follicular phase

Study Arms (2)

Diode laser coagulation

EXPERIMENTAL

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

Procedure: Diode laser coagulation

Bipolar coaugulation

ACTIVE COMPARATOR

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Procedure: Bipolar coagulation

Interventions

Diode laser coagulation PROCEDURE

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

Diode laser coagulation

Bipolar coagulation PROCEDURE

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Bipolar coaugulation

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• regular menstrual cycles
• unilateral endometrioma greater than 35 mm
• no gynecological surgery 3-6 months before surgery
• no hormonal therapy 1 month before surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead
• University of Foggia: collaborator

Study Sites (1)

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 22, 2016

Record last verified: 2016-04

Locations

IT (1)