Optimum Menstrual Cycle Time for Endometrioma Excision

Completed

• Conditions: Endometriosis; Endometrioma
• Interventions: Procedure: laparoscopic endometrioma cyst excision

• Registration Number: NCT03484546
• Lead Sponsor: Acibadem University

Brief Summary

This study evaluates the optimum day of menstrual period for the excision of endometriomas to minimize the damage of surgery to normal ovarian tissue. Patients will be grouped as follicular, ovulatory and luteal according to menstrual days. Ovarian damage will be evaluated with both pathologic examination and anti-mullerian hormone levels before and after the surgery.

Detailed Description

Endometriosis is a common gynecologic disease seen in about 10% of women in reproductive age. The most common site of endometriosis is overt. Cystic formation of ovarian endometriosis is called endometrioma (chocolate cyst). Definitive treatment of endometriomas is excision by laparoscopy. The disadvantage of this surgery is the removal of some of the normal ovarian follicles within cystectomy material. This procedure can damage the ovarian reserves with the treatment of endometriomas, which are already the cause of infertility, and lead to the conditions such as infertility or early menopause. It has been understood that the ovarian reserves of the patients who underwent endometrioma cystectomy with the decrease of the Anti-Mullerian Hormone values, which is an over reserve parameter.

Study Timeline

• Study Start: 2018-03-26
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-21
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• 4 to 10 cm unilateral ovarian endometrioma
• having clinically indication of laparoscopic ovarian endometrioma excision

Exclusion Criteria

• prior gynecologic surgery
• prior abdominal surgery
• additional operation in the same session
• having the diagnosis of premature ovarian failure or ovarian insufficiency
• having any diagnosis of malignancy
• having diagnosis of a non-gynecologic chronicle disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
luteal	laparoscopic endometrioma cyst excision	Women who will undergo endometrioma cystectomy in her luteal phase of menstrual period.
folicular	laparoscopic endometrioma cyst excision	Women who will undergo endometrioma cystectomy in her follicular phase of menstrual period.
ovulatory	laparoscopic endometrioma cyst excision	Women who will undergo endometrioma cystectomy in her ovulatory phase (12-14th day of mestrual period cycle for women regular period) of menstrual cycle.

Primary Outcome Measures

Name	Time	Method
Determination of ovarian follicle damage via histological examination	5 days after the surgery	Histologic evaluation of the cystectomy excision material for health ovarian follicles
Change of anti-mullerian hormone level 6 months after surgery	6 months	Comparison of pre-operative and 6 months after surgery of anti-mullerian hormone levels

Trial Locations

Locations (3)

Acibadem MAA University Atakent Hospital; 🇹🇷 Istanbul, Turkey

Acibadem Fulya Hospital; 🇹🇷 Istanbul, Turkey

Acibadem MAA University Maslak Hospital; 🇹🇷 Istanbul, Turkey