Optimum Menstrual Cycle Time for Endometrioma Excision

NCT ID: NCT03484546

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-26

Study Completion Date

2021-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endometriosis Endometrioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

folicular

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

laparoscopic endometrioma cyst excision

Intervention Type PROCEDURE

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.

laparoscopic endometrioma cyst excision

Intervention Type PROCEDURE

laparoscopic resection of ovarian endometrioma

luteal

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

laparoscopic endometrioma cyst excision

Intervention Type PROCEDURE

laparoscopic resection of ovarian endometrioma

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

laparoscopic endometrioma cyst excision

laparoscopic resection of ovarian endometrioma

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acibadem University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Turgut Aydın

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ozguc Takmaz

Role: PRINCIPAL_INVESTIGATOR

Acibadem MAA University Maslak Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Acibadem Fulya Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Acibadem MAA University Atakent Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Acibadem MAA University Maslak Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39473503 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AcibademGynecology

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Surgery and ART For Endometrioma
NCT03717870 NOT_YET_RECRUITING NA