The Therapy of Large Endometrioma

NCT ID: NCT04704115

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-21

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Endometrioma Endometriosis Ovary

Keywords

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Endometriomas measuring 6 cm or more Ovarian Endometrioma laparoscopic drainage recurrence AMH GnRH agonist therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chrytèle RUBOD, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lisle-sur-Tarn, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Chrytèle RUBOD, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Role: primary

Other Identifiers

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2020-A02354-35

Identifier Type: OTHER

Identifier Source: secondary_id

2019_43

Identifier Type: -

Identifier Source: org_study_id