Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy
NCT ID: NCT07065214
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2025-11-26
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard cystectomy
Investigator uses lap bipolar forceps for endometrioma treatment (standard treatment)
Lap bipolar forceps
For ovarian endometrioma treatment the standard of care treatment will be performed.
APC treatment
Investigator uses APC applicator for endometrioma treatment. This is a CE approved device
APC
For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used
Interventions
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APC
For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used
Lap bipolar forceps
For ovarian endometrioma treatment the standard of care treatment will be performed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
* 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
18 Years
40 Years
FEMALE
No
Sponsors
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Erbe Elektromedizin GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Bernhard Krämer, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Department for Women's Health, Tuebingen, Germany
Locations
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Department for Women's Health
Tübingen, Germany, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Younis JS, Shapso N, Ben-Sira Y, Nelson SM, Izhaki I. Endometrioma surgery-a systematic review and meta-analysis of the effect on antral follicle count and anti-Mullerian hormone. Am J Obstet Gynecol. 2022 Jan;226(1):33-51.e7. doi: 10.1016/j.ajog.2021.06.102. Epub 2021 Jul 13.
Stefanovic S, Sutterlin M, Gaiser T, Scharff C, Neumann M, Berger L, Froemmel N, Tuschy B, Berlit S. Microscopic, Macroscopic and Thermal Impact of Argon Plasma, Diode Laser, and Electrocoagulation on Ovarian Tissue. In Vivo. 2023 Mar-Apr;37(2):531-538. doi: 10.21873/invivo.13111.
Lockyer EK, Schreurs A, Lier M, Dekker J, Melgers I, Mijatovic V. Treatment of ovarian endometriomas using plasma energy in endometriosis surgery: effect on pelvic pain, return to work, pregnancy and cyst recurrence. Facts Views Vis Obgyn. 2019 Mar;11(1):49-55.
Working group of ESGE, ESHRE, and WES; Saridogan E, Becker CM, Feki A, Grimbizis GF, Hummelshoj L, Keckstein J, Nisolle M, Tanos V, Ulrich UA, Vermeulen N, De Wilde RL. Recommendations for the surgical treatment of endometriosis-part 1: ovarian endometrioma. Gynecol Surg. 2017;14(1):27. doi: 10.1186/s10397-017-1029-x. Epub 2017 Dec 19.
Muzii L, Achilli C, Bergamini V, Candiani M, Garavaglia E, Lazzeri L, Lecce F, Maiorana A, Maneschi F, Marana R, Perandini A, Porpora MG, Seracchioli R, Spagnolo E, Vignali M, Benedetti Panici P. Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentre RCT. Hum Reprod. 2016 Feb;31(2):339-44. doi: 10.1093/humrep/dev313. Epub 2015 Dec 18.
Other Identifiers
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OVAPLAS
Identifier Type: -
Identifier Source: org_study_id
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