Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Müllerian hormone.
Johnny S Younis, Nora Shapso, Yval Ben-Sira...
https://pubmed.ncbi.nlm.nih.gov/34265271/Actively Recruiting
Led by Erbe Elektromedizin GmbH · Updated on 2025-11-28
72
Participants Needed
1
Research Sites
30 weeks
Total Duration
Researchers are evaluating two surgical methods for treating ovarian endometrioma in women to understand how each method affects ovarian reserve. This pilot study compares the standard cystectomy procedure with argon plasma coagulation APC treatment by monitoring changes in serum Anti-Mller hormone AMH levels after surgery. The study is conducted as a prospective, randomized controlled trial at the Department for Womens Health in Tuebingen, Germany. Participants will be randomly assigned to one of two groups one receiving the standard cystectomy using lap bipolar forceps, and the other undergoing APC treatment with a CE-approved APC applicator device. The surgical treatment will be performed during the second visit. Follow-up visits are scheduled at three, six, and twelve months after the procedure, with AMH levels measured during the three- and six-month visits. The twelve-month follow-up will be conducted through a phone call. Women who qualify will participate in five visits screening, treatment, and three follow-ups. Screening occurs first to confirm eligibility. Blood tests to measure AMH levels will be done at the study site during follow-up visits three and four. The final follow-up will be remote via telemedicine. Safety and treatment effects will be assessed throughout, with the main outcome focused on changes in AMH concentration up to six months post-treatment.
CONDITIONS
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
V
Vanessa Steinmetz
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Erbe Elektromedizin GmbH
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants undergo surgical treatment of ovarian endometrioma using either standard cystectomy or argon plasma coagulation (APC) applicator.
1 surgery visit (in-person)
Duration - 6 months
Participants have follow-up visits to monitor recovery and assess Anti-Müller hormone (AMH) levels after surgery.
2 visits (at 3 months and 6 months post-surgery, in-person)
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29285022/Erbe Elektromedizin GmbH
Lead Sponsor