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NCT Number: NCT03484546

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.

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Key information

Conditions

Endometriosis Endometrioma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Acibadem Fulya Hospital, Istanbul, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic endometrioma cyst excision

Procedure

laparoscopic resection of ovarian endometrioma

Primary outcomes

  1. Determination of ovarian follicle damage via histological examination

    Time frame: 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

    Time frame: 6 months

    Comparison of pre-operative and 6 months after surgery of anti-mullerian hormone levels

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 2, 2018
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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