The Therapy of Large Endometrioma

Recruiting

• Conditions: Endometrioma; Endometriosis Ovary

• Registration Number: NCT04704115
• Lead Sponsor: University Hospital, Lille

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Study Start: 2021-01-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-27
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 62

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Recurrence of cyst ≥ 3 cm determined by MRI or pelvic ultrasonography (US)	at 3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lisle-sur-Tarn, France