Surgical options to preserve ovaries when treating endometriomas
Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy
This trial will see if different surgical methods for treating endometriomas help women who want to get pregnant have higher pregnancy and birth rates and fewer complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 332 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | Clinique Tivoli Ducos Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07119060 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study will enroll women aged 18–43 with at least one endometrioma larger than 20 mm who intend to conceive after surgery. Participants are randomly assigned to one of several surgical approaches — cystectomy, plasma vaporization, or sclerotherapy — performed at Clinique Tivoli in Bordeaux. Researchers will track pregnancies (natural and with fertility treatment), births continuing beyond 12 weeks, recurrence of endometriomas, surgical complications, and changes in pain using follow-up visits at about 3 months and 24 months after the procedure. The primary outcome is pregnancy within 24 months, with secondary outcomes including birth rates, recurrence, complications, and pain scores.
Who should consider this trial
Good fit: Women aged 18–43 with symptomatic endometriosis and at least one endometrioma >20 mm who plan to try to conceive after surgery and can attend follow-up visits are ideal candidates.
Not a fit: Patients who are not planning pregnancy, are pregnant or breastfeeding, have cysts later found not to be endometriomas, are under legal guardianship, or cannot understand French are unlikely to benefit.
Why it matters
Potential benefit: If successful, the results could identify the surgical method that best preserves ovarian function and improves the chance of pregnancy while reducing recurrence and complications.
How similar studies have performed: Previous studies have shown mixed results: cystectomy can reduce recurrence but may reduce ovarian reserve, while sclerotherapy and ablation techniques are less invasive with limited and inconsistent evidence on pregnancy outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Bordeaux
- IFEMEndo - Clinique Tivoli — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Adrien CRESTANI — IFEMEndo - Clinique Tivoli
- Study coordinator: Clotilde HUET
- Email: recherche@ifemendo.fr
- Phone: +33 7 85 30 63 45
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.