Argon plasma coagulation versus standard cystectomy for ovarian endometrioma
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study
This trial will test whether argon plasma coagulation preserves ovarian reserve better than standard cystectomy for people having surgery for ovarian endometriomas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Erbe Elektromedizin GmbH Industry-sponsored |
| Locations | 1 site (Tübingen, Germany) |
| Trial ID | NCT07065214 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, randomized controlled pilot trial enrolling 72 patients with symptomatic ovarian endometriomas who are scheduled for surgery. Participants are randomized 1:1 to receive either standard cystectomy or argon plasma coagulation (APC) during laparoscopy. The main outcome compares changes in serum AMH from before surgery to follow-up at 6 months, with a pre-specified primary endpoint analysis after the last patient completes Visit 4. The trial is conducted at the Department for Women's Health in Tübingen, Germany, under a post-market evaluation framework.
Who should consider this trial
Good fit: People with symptomatic ovarian endometriomas who are scheduled for surgical treatment, can give informed consent, and meet the study's eligibility criteria are ideal candidates.
Not a fit: Patients who have had prior ovarian surgery, recurrent ovarian endometrioma, are pregnant or breastfeeding, cannot comply with follow-up, or are enrolled in other studies affecting AMH are not eligible and likely would not benefit from this trial.
Why it matters
Potential benefit: If successful, APC could better preserve ovarian reserve and reduce the impact of surgery on future fertility compared with standard cystectomy.
How similar studies have performed: Standard cystectomy is a well-established treatment known to affect ovarian reserve, while APC for ovarian endometrioma is less studied and has only limited preliminary evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Indication for surgical endometrioma treatment according to patient symptoms * Signed informed consent Exclusion Criteria: * Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial * Prior procedures at the ovaries * Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included) * Pregnant or breastfeeding patients * Participation in any other clinical study that could affect the AMH level or pregnancy
Where this trial is running
Tübingen, Germany
- Department for Women's Health — Tübingen, Germany, Germany (Recruiting)
Study contacts
- Principal investigator: Bernhard Krämer, Prof. Dr. med. — Department for Women's Health, Tuebingen, Germany
- Study coordinator: Vanessa Steinmetz
- Email: vanessa.steinmetz@erbe-med.com
- Phone: +49 70717552850
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.