| NCT ID | NCT04704115 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Endometrioma |
| Study Type | OBSERVATIONAL |
| Enrollment | 62 participants |
| Start Date | 2021-01-21 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 62 participants in total. It began in 2021-01-21 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Endometrioma's prevalence is between 23 and 55%. It causes pelvic pain, decrease fertility and ovarian reserve. Currently, there's no recommendation about large endometrioma's treatment and there's no information on the best treatment to limit recurrences, preserve fertility and ovarian reserve. In Lille university hospital, simple laparoscopic drainage associated with hormonal therapy is practiced to reduce the risk of cystectomy. This protocol will be evaluated with an observational and prospective study, including women of childbearing age having endometrioma measuring 6 cm or above. The aim of this study is to assess if cyst drainage associated with GnRH agonist, could decrease endometrioma recurrences, deleterious effect on ovarian reserve and evaluate impact on anti-mullerian hormone
Eligibility 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
Contact & Investigator
Chrytèle RUBOD, MD,PhD
PRINCIPAL INVESTIGATOR
University Hospital, Lille
Frequently Asked Questions
Who can join the NCT04704115 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Endometrioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04704115 currently recruiting?
Yes, NCT04704115 is actively recruiting participants. Contact the research team at chrystele.rubod@chru-lille.fr for enrollment information.
Where is the NCT04704115 trial being conducted?
This trial is being conducted at Lisle-sur-Tarn, France.
Who is sponsoring the NCT04704115 clinical trial?
NCT04704115 is sponsored by University Hospital, Lille. The principal investigator is Chrytèle RUBOD, MD,PhD at University Hospital, Lille. The trial plans to enroll 62 participants.