Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy

Recruiting now · Not applicable

Conditions studied: Endometriosis

In brief

The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment. Seventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization. A pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint. Screening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.

Key facts

Study ID

NCT07065214

Run by

Erbe Elektromedizin GmbH

People needed

72

Starts

2025-11-26

Expected to finish

2027-09-30

Last updated by the study team

2025-11-28

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Indication for surgical endometrioma treatment according to patient symptoms
• Signed informed consent

You may not qualify if…

• 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 it is running

• Department for Women's Health — Tübingen, Germany, Germany (enrolling)

Full record on ClinicalTrials.gov

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