Ablative Technique For Ovarian Preservation In Endometrioma

NCT07119060 | Recruiting

• 2 other identifiers: CliTiv-01-20252024-A01400-47
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are: How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment? Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications. Participants will: Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period

Conditions

Endometrioma; Fertility

Keywords

surgery; endometrioma; endometriosis; kystectomy; sclerotherapy; plasma vaporization; fertility

Outcome Measures

Primary Outcomes (1)

• To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment

  A Pregnancy is considered if the CGH is \>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea

  From enrollment to 24 months after the surgery

Secondary Outcomes (7)

• To compare birth rates pregnancies

  From enrollment to 24 months after the surgery

• To compare spontaneous pregnancy rates

  From enrollment to 24 months after the surgery

• To compare pregnancies achieved through assisted reproductive technology (ART)

  From enrollment to 24 months after the surgery

• To compare pregnancies progressing beyond 12 weeks of amenorrhea

  From enrollment to 24 months after the surgery

• To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary.

  From enrollment to 24 months after the surgery

Study Arms (3)

cystectomy

EXPERIMENTAL

Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)

Procedure: Cystectomy

vaporization with plasma

ACTIVE COMPARATOR

It consists of destroying the cyst wall (vaporization) using plasma energy.

Procedure: plasma vaporization

sclerotherapy

OTHER

Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol.

Procedure: Sclerotherapy

Interventions

Cystectomy PROCEDURE

Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)

cystectomy

plasma vaporization PROCEDURE

It consists of destroying the cyst wall (vaporization) using plasma energy

vaporization with plasma

Sclerotherapy PROCEDURE

Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol

sclerotherapy

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient aged between 18 and 43 years (inclusive)
• Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ)
• Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter
• Patient with an intention to conceive (probable or certain) after surgery
• Patient informed and having signed the consent form
• Patient covered by a social security scheme

You may not qualify if:

• Intraoperative finding that the cyst is not an endometrioma
• Patient under guardianship, conservatorship, or incapable of giving consent
• Patient without sufficient understanding of the French language
• Patient under judicial protection measures
• Patient who is pregnant or breastfeeding

Sponsors & Collaborators

• Clinique Tivoli Ducos: lead

Study Sites (1)

IFEMEndo - Clinique Tivoli

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Endometriosis

Interventions

Cystectomy; Sclerotherapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Drug Therapy; Therapeutics

Study Officials

• Horace ROMAN

  IFEMEndo - Clinique Tivoli

  STUDY DIRECTOR

• Adrien CRESTANI

  IFEMEndo - Clinique Tivoli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clotilde HUET

CONTACT

+33 7 85 30 63 45; recherche@ifemendo.fr

Kristina ANANIAN

CONTACT

+33 6 50 13 92 54; arc@ifemendo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 12, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): January 1, 2035
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be available beginning 12 months after publication of the primary results, for a period of 3 years.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal and whose aims are compatible with the original study objectives

Locations

FR (1)