The Therapy of Large Endometrioma | NCT04704115

Studies
The Therapy of Large Endometrioma

NCT04704115

Sponsor

University Hospital, Lille

Status

Recruiting

Last Update Posted

Dec 23, 2025Actual

Enrollment

62Estimated

Phase

Not provided

Conditions

Endometrioma
Endometriosis Ovary

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A02354-35	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 21, 2021Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Jan 7, 2021

First Submission Date that Met QC Criteria

Jan 7, 2021

First Posted Date

Jan 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2025

Last Update Posted Date

Dec 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chrytèle RUBOD, MD,PhD	Contact	0320445962	+33	chrystele.rubod@chru-lille.fr

Overall Officials

Name	Affiliation	Role
Chrytèle RUBOD, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hop Jeanne de Flandre Chu Lille	Recruiting	Lisle-sur-Tarn		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis
D012008	Recurrence

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided