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/34265271Actively Recruiting
Phase Not Applicable
Age: 18Years - 40Years
FEMALE
ID07065214
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study
Led by Erbe Elektromedizin GmbH · Updated on 2025-11-28
72
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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-Müller hormone (AMH) levels after surgery. The study is conducted as a prospective, randomized controlled trial at the Department for Women's 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
Brief Title
Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
Who Can Participate
Age: 18Years - 40Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Indication for surgical endometrioma treatment according to patient symptoms
- Signed informed consent
- Female aged between 18 and 40 years
You will not qualify if you...
- Expected lack of compliance or inability to understand the clinical trial purpose
- Prior procedures at the ovaries
- Recurrent ovarian endometrioma
- Pregnant or breastfeeding patients
- Participation in any other clinical study that could affect AMH level or pregnancy status
- Male gender
- Age below 18 or above 40 years old
- Patients with recurrent endometriosis outside the ovaries only (allowed if no ovarian recurrence)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
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)
Post-operative Follow-up
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)
Trial Site Locations
Total: 1 location
1
Department for Women's Health
Tübingen, Germany, Germany, 72076
Actively Recruiting
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Research Team
V
Vanessa Steinmetz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue.
Stefan Stefanovic, Marc Sütterlin, Timo Gaiser...
https://pubmed.ncbi.nlm.nih.gov/36881055Treatment of ovarian endometriomas using plasma energy in endometriosis surgery: effect on pelvic pain, return to work, pregnancy and cyst recurrence.
E K Lockyer, Amf Schreurs, McI Lier...
https://pubmed.ncbi.nlm.nih.gov/31695857Recommendations for the surgical treatment of endometriosis-part 1: ovarian endometrioma.
Working group of ESGE, ESHRE, and WES, Ertan Saridogan, Christian M Becker...
https://pubmed.ncbi.nlm.nih.gov/29285022Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT.
Ludovico Muzii, Chiara Achilli, Valentino Bergamini...
https://pubmed.ncbi.nlm.nih.gov/26682578