Optimum Menstrual Cycle Time for Endometrioma Excision

NCT03484546 | Completed

• 1 other identifier: AcibademGynecology
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometriosis; Endometrioma

Keywords

ovarian reserve; endometriosis; endometrioma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

folicular

Women who will undergo endometrioma cystectomy in her follicular phase of menstrual period.

Procedure: laparoscopic endometrioma cyst excision

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

luteal

Women who will undergo endometrioma cystectomy in her luteal phase of menstrual period.

Procedure: laparoscopic endometrioma cyst excision

Interventions

laparoscopic endometrioma cyst excision PROCEDURE

laparoscopic resection of ovarian endometrioma

folicular; luteal; ovulatory

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (3)

Acibadem Fulya Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Acibadem MAA University Atakent Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Acibadem MAA University Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Related Publications (1)

• Takmaz O, Asoglu MR, Ceyhan M, Unsal G, Gungor M. Comparing ovarian reserve parameters after laparoscopic endometrioma resection in the follicular vs. luteal phase: a prospective cohort study. Front Med (Lausanne). 2024 Oct 15;11:1469858. doi: 10.3389/fmed.2024.1469858. eCollection 2024.

  PMID: 39473503 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ozguc Takmaz

  Acibadem MAA University Maslak Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 2, 2018
• Study Start: March 26, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

TU (3)