Optimum Menstrual Cycle Time for Endometrioma Excision

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis; Endometrioma
• Intervention / Treatment: Procedure: laparoscopic endometrioma cyst excision

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34457
    • Acibadem MAA University Atakent Hospital
  • Istanbul, Turkey, 34457
    • Acibadem Fulya Hospital
  • Istanbul, Turkey, 34457
    • Acibadem MAA University Maslak Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women who admitted to out-patient clinic between the ages of 18-40 years,had 4-10cm ovarian unilateral endometrioma and had an indication of laparoscopic ovarian endometrioma excision.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
folicular; Women who will undergo endometrioma cystectomy in her follicular phase of menstrual period.	Procedure: laparoscopic endometrioma cyst excision; laparoscopic resection of ovarian endometrioma
ovulatory; Women who will undergo endometrioma cystectomy in her ovulatory phase (12-14th day of mestrual period cycle for women regular period) of menstrual cycle.	Procedure: laparoscopic endometrioma cyst excision; laparoscopic resection of ovarian endometrioma
luteal; Women who will undergo endometrioma cystectomy in her luteal phase of menstrual period.	Procedure: laparoscopic endometrioma cyst excision; laparoscopic resection of ovarian endometrioma

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Principal Investigator: Ozguc Takmaz, Acibadem MAA University Maslak Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2018
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 21, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: endometriosis; ovarian reserve; endometrioma
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: AcibademGynecology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing will be decided during the study process.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No