ENDOKYSTE: The Therapy of Large Endometrioma

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04704115

Collaborator

(none)

Enrollment

Location

31.3

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endometrioma Endometriosis Ovary

Study Design

Study Type:

Observational

Anticipated Enrollment :

62 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluate the Therapy of Large Ovarian Endometrioma

Actual Study Start Date :

Jan 21, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Outcome Measures

Primary Outcome Measures

Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US) [at 3 months]

Secondary Outcome Measures

The impact of the ovarian reserve postoperative [at 3 months]
Compare the dosages of anti-mullerian hormone (AMH) preoperative and postoperative at 3 months
The number of re-operation [at 4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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