Laparoscopic drainage plus hormonal therapy for large ovarian endometriomas
Evaluate the Therapy of Large Ovarian Endometrioma
This study will test whether laparoscopic cyst drainage followed by a GnRH agonist helps women of childbearing age with ovarian endometriomas 6 cm or larger have fewer recurrences and preserve ovarian reserve.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 1 site (Lisle-sur-Tarn) |
| Trial ID | NCT04704115 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling women of childbearing age with ovarian endometriomas measuring 6 cm or more. Participants managed at Lille will undergo simple laparoscopic drainage followed by treatment with a GnRH agonist as practiced at the center. The study will track cyst recurrence and ovarian reserve over time, including measurement of anti-Müllerian hormone (AMH) and imaging follow-up. Data will be collected without randomization to compare outcomes of this conservative approach against expected recurrence and reserve patterns.
Who should consider this trial
Good fit: Women of childbearing age with one or bilateral ovarian endometriomas measuring 6 cm or larger on ultrasound or MRI who are eligible for laparoscopy and not pregnant.
Not a fit: Patients with cysts showing radiographic or intraoperative atypia, those who are pregnant, or those with contraindications to GnRH agonists, laparoscopy, or general anesthesia are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce the need for cystectomy and help preserve ovarian reserve and fertility in women with large endometriomas.
How similar studies have performed: Complete cystectomy has been well studied and lowers recurrence but often reduces ovarian reserve, whereas laparoscopic drainage combined with postoperative hormonal suppression is less well studied and has limited supporting data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lisle-sur-Tarn
- Hop Jeanne de Flandre Chu Lille — Lisle-sur-Tarn, France (Recruiting)
Study contacts
- Principal investigator: Chrytèle RUBOD, MD,PhD — University Hospital, Lille
- Study coordinator: Chrytèle RUBOD, MD,PhD
- Email: chrystele.rubod@chru-lille.fr
- Phone: 0320445962
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.