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Optimum Menstrual Cycle Time for Endometrioma Excision

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ClinicalTrials.gov Identifier: NCT03484546
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Ozguc Takmaz, Acibadem University

Study Description
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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
Endometriosis Endometrioma 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
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimum Menstrual Cycle Time for Endometrioma Excision
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484546


Contacts
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Contact: Ozguc Takmaz 00905554006591 ozguctakmaz@hotmail.com
Contact: Mete Gungor 002123044970 mete.gungor@acibadem.edu.tr

Locations
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Turkey
Acibadem Fulya Hospital Recruiting
Istanbul, Turkey, 34457
Contact: Ercan Bastu, MD,AssocProf    +905324134195    ercan.bastu@acibadem.com   
Acibadem MAA University Atakent Hospital Recruiting
Istanbul, Turkey, 34457
Contact: Emine Karabuk, MD    +905336487171    emine.karauk@acibadem.com   
Contact: Murat Naki, MD,Prof    +905327706666    murat.naki@acibadem.com   
Acibadem MAA University Maslak Hospital Recruiting
Istanbul, Turkey, 34457
Contact: Ozguc Takmaz, MD,AssistProf    +905554006591    ozguctakmaz@hotmail.com   
Contact: Mete Gungor, MD,Prof    +902123044970    mete.gungor@acibadem.com   
Sponsors and Collaborators
Acibadem University
Investigators
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Principal Investigator: Ozguc Takmaz Acibadem MAA University Maslak Hospital
More Information
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Responsible Party: Ozguc Takmaz, Assistant Professor, Acibadem University
ClinicalTrials.gov Identifier: NCT03484546    
Other Study ID Numbers: AcibademGynecology
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sharing will be decided during the study process.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ozguc Takmaz, Acibadem University:
ovarian reserve
endometriosis
endometrioma
Additional relevant MeSH terms:
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Endometriosis