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Studies

Interventional Recruiting

NCT07119060 on ClinicalTrials.gov

Ablative Technique For Ovarian Preservation In Endometrioma

Official title: Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy

  • Sponsor: Clinique Bordeaux Tivoli-Ducos
  • Enrollment: 332 (Estimated)
  • Study start: 2025-09-18 (Actual)
  • Primary completion: 2034-07-01 (Estimated)
  • Study completion: 2035-01-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Procedure: Cystectomy
  • Procedure: plasma vaporization
  • Procedure: Sclerotherapy

Primary Outcome Measures

  • To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment (From enrollment to 24 months after the surgery)
    A Pregnancy is considered if the CGH is \>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea

Countries

France

Locations and Investigators

  • IFEMEndo - Clinique Tivoli, Bordeaux, France (Recruiting)
    • Clotilde HUET
    • Kristina ANANIAN
    • Adrien CRESTANI (Principal Investigator)
    • Paul Henri GOUALARD
    • Thomas DENNIS
    • Benjamin MERLOT
    • Horace ROMAN

Study Officials