NCT04461899

Brief Summary

Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal). Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve. Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery. Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility. The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

July 9, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2023

Completed
Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

June 29, 2020

Last Update Submit

September 22, 2023

Conditions

Endometriosis Ovary

Keywords

endometriomasclerotherapyovarian reserveantimüllerian hormone

Outcome Measures

Primary Outcomes (1)

  • AMH level

    3 months (+/-15 days) after endometrioma sclerotherapy

Secondary Outcomes (4)

  • AMH level

    12 months (+/-15 days) after endometrioma sclerotherapy

  • AMH level

    12 months after endometrioma sclerotherapy

  • Endometrioma recurrence

    3 months (+/-15 days) after endometrioma sclerotherapy

  • Endometrioma recurrence

    12 months (+/-15 days) after endometrioma sclerotherapy

Study Arms (1)

sclerotherapy

OTHER

a sclerotherapy will be done in patients

Biological: Blood test

Interventions

Blood testBIOLOGICAL

additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.

sclerotherapy

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient in childbearing age from 18 to 42 years.
  • Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
  • A sclerotherapy is programmed.
  • Patient affiliated to a social security scheme.
  • Patient who gave consent for this research.

You may not qualify if:

  • doubt about the endometriotic origin of the cyst
  • suspect malignant ovarian disease.
  • Pregnant or breastfeeding patient.
  • Patient deprived of liberty by judicial or administrative decision.
  • Patient (≥ 18 years old) under legal protection or unable to give consent.
  • Patient does not speak French.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hopital Femme Mère Enfant

Bron, France

Location

Hopital de la Croix Rousse

Lyon, 69004, France

Location

Hopital Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Gil DUBERNARD, Pr

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

July 9, 2020

Primary Completion

April 14, 2023

Study Completion

April 14, 2023

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

FR(3)