Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

Not Applicable

Completed

• Conditions: Endometrioma
• Interventions: Procedure: laparoscopic cyst deroofing; Procedure: Laparoscopic ovarian cystectomy

• Registration Number: NCT01808170
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Detailed Description

One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

Inclusion Criteria

1. Age from 18-35 year
2. Regular menstrual cycles.
3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion criteria:

1. Any previous ovarian surgery.

2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

   -Two of three of:

   • Oligo- or chronic anovulation.
   • Clinical and/or biochemical signs of hyperandrogenism.
   • Polycystic ovaries.

3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L

4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.

5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.

6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.

7. Contraindication to surgery.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic cyst deroofing	laparoscopic cyst deroofing	laparoscopic cyst deroofing will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.
laparoscopic ovarian cystectomy	Laparoscopic ovarian cystectomy	laparoscopic ovarian cystectomy will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.

Primary Outcome Measures

Name	Time	Method
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by alteration of AMH level in endometrioma patients.	17 months

Secondary Outcome Measures

Name	Time	Method
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by antral follicle count estimation in endometrioma patients.	17 months
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients.	17 months

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Egypt