The Therapy of Large Endometrioma (ENDOKYSTE)

January 26, 2023 updated by: University Hospital, Lille

Evaluate the Therapy of Large Ovarian Endometrioma

Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve.

Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve.

In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy.

This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above.

The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone

Study Overview

Status

Recruiting

Study Type

Observational

Enrollment (Anticipated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Lisle-sur-Tarn, France, 59037
        • Recruiting
        • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women presenting at a surgical consultation for the management of an endometrioma of 6cm or more

Description

Inclusion Criteria:

  • Endometrioma size ≥ 6cm determined by MRI or ultrasonography
  • Women with isolated endometrioma or other extraovarian endometriosis: peritoneal, infiltrating endometriotic lesions and adenomyosis.
  • Cyst single or bilateral

Exclusion Criteria:

  • Cyst with radiographic or macroscopic in laparoscopy atypia
  • Pregnancy
  • Patient with contraindication to GnRH agonist (Enantone® 3,75 mg et Decapeptyl® 3 mg)
  • Patient with contraindication to laparoscopy
  • Patient with contraindication to general anesthesia
  • Subject refusing to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of the ovarian reserve postoperative
Time Frame: at 3 months
Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months
at 3 months
The number of re-operation
Time Frame: at 4 months
at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Chrytèle RUBOD, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_43
  • 2020-A02354-35 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endometrioma

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