Optimum Menstrual Cycle Time for Endometrioma Excision

Endometriosis Clinical Trial

Official title:

Optimum Menstrual Cycle Time for Endometrioma Excision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03484546
• Other study ID #: AcibademGynecology
• Status: Completed
• Start date: March 26, 2018
• Est. completion date: October 1, 2021

Study information

• Verified date: October 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

Procedure:
• laparoscopic endometrioma cyst excision
laparoscopic resection of ovarian endometrioma

Locations

Country	Name	City	State
Turkey	Acibadem Fulya Hospital	Istanbul
Turkey	Acibadem MAA University Atakent Hospital	Istanbul
Turkey	Acibadem MAA University Maslak Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of ovarian follicle damage via histological examination	Histologic evaluation of the cystectomy excision material for health ovarian follicles	5 days after the surgery
Primary	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