Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy

NCT07065214 | Recruiting

• 1 other identifier: OVAPLAS
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis

Keywords

ovarian endometriosis

Outcome Measures

Primary Outcomes (1)

• Concentration of AMH (Anti-Müller hormone) level

  The comparison of patient AMH changes (ΔAMH) before and after surgery (Follow up Visit after 3 and 6 months) with either APC or standard cystectomy (ΔAMH Group 1 versus ΔAMH Group 2).

  Screening Visit 1 (up to -28 days before day 0); Visit 3 (day 0 +3 months +/- 14 days; Visit 4 (day 0 + 6 months +/- 14 days)

Study Arms (2)

Standard cystectomy

OTHER

Investigator uses lap bipolar forceps for endometrioma treatment (standard treatment)

Device: Lap bipolar forceps

APC treatment

EXPERIMENTAL

Investigator uses APC applicator for endometrioma treatment. This is a CE approved device

Device: APC

Interventions

APC DEVICE

For the surgical procedure for ovarian endometrioma treatment APCapplicator will be used

Also known as: APC Treatment with APCapplicator

APC treatment

Lap bipolar forceps DEVICE

For ovarian endometrioma treatment the standard of care treatment will be performed.

Standard cystectomy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Erbe Elektromedizin GmbH: lead

Study Sites (1)

Department for Women's Health

Tübingen, Germany, 72076, Germany

RECRUITING

Related Publications (5)

• 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.

  PMID: 34265271 BACKGROUND

• 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.

  PMID: 36881055 BACKGROUND

• 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.

  PMID: 31695857 BACKGROUND

• 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.

  PMID: 29285022 BACKGROUND

• 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.

  PMID: 26682578 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Bernhard Krämer, Prof. Dr. med.

  Department for Women's Health, Tuebingen, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa Steinmetz

CONTACT

+49 70717552850; vanessa.steinmetz@erbe-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 15, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

DE (1)