Optimum Menstrual Cycle Time for Endometrioma Excision

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03484546
Collaborator
(none)
60
3
42.2
20
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Optimum Menstrual Cycle Time for Endometrioma Excision
Actual Study Start Date :
Mar 26, 2018
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Determination of ovarian follicle damage via histological examination [5 days after the surgery]

    Histologic evaluation of the cystectomy excision material for health ovarian follicles

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acibadem Fulya Hospital Istanbul Turkey 34457
2 Acibadem MAA University Atakent Hospital Istanbul Turkey 34457
3 Acibadem MAA University Maslak Hospital Istanbul Turkey 34457

Sponsors and Collaborators

  • Acibadem University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ozguc Takmaz, Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier:
NCT03484546
Other Study ID Numbers:
  • AcibademGynecology
First Posted:
Apr 2, 2018
Last Update Posted:
Jul 12, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ozguc Takmaz, Assistant Professor, Acibadem University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 12, 2021