Ovarian function after the use of various hemostatic techniques during treatment for endometrioma: protocol for a randomized clinical trial

Raquel Silveira da Cunha Araújo, Sabina Bastos Maia, Clara Micalli Ferruzzi Baracat, Moisés Diôgo de Lima, Moisés Diogo Lima, Eduardo Sérgio Sousa Soares, Helizabet Salomão Abdalla Ayroza Ribeiro, Paulo Augusto Ayroza Galvão Ribeiro, Paulo Ayroza Ribeiro
Trials · 2019 · vol. 20(1) , pp. 410 · doi:10.1186/s13063-019-3524-z · PMID:31288827 · PMC6617678 · W2958310395
article OA: gold CC0 ⤵ 9 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This randomized clinical trial will compare bipolar coagulation, laparoscopic suture, and hemostatic matrix for ovarian function after endometrioma surgery by measuring anti-Müllerian hormone and antral follicle count.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-10 ⓘ

This open-label randomized clinical trial protocol aims to compare how different hemostatic techniques used during laparoscopic surgery for unilateral ovarian endometrioma affect ovarian function, using serum anti-Müllerian hormone (AMH) and ultrasound antral follicle count (AFC) measured before surgery and at 1, 3, and 6 months after. Eighty-four women will be randomized to bipolar coagulation, laparoscopic suturing, or placement of an absorbable hemostatic matrix, with bipolar energy application described in detail by counting coagulated points and measuring coagulation time. The protocol acknowledges existing controversies that ovarian reserve may be reduced either by thermal coagulation injury or by the surgical procedure and that prior studies have been inconclusive, including limited details about bipolar energy use. This paper is centrally about endometriosis — specifically an ovarian endometrioma trial protocol evaluating whether bipolar coagulation versus suturing versus a hemostatic matrix differentially impacts post-surgical ovarian reserve.

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Abstract

BACKGROUND: Laparoscopic cystectomy is currently considered the gold standard for the treatment of ovarian endometrioma, resulting in an improvement in symptoms, a lower recurrence rate, and a higher pregnancy rate among infertile patients. However, this treatment is not free from risk, since it is associated with a reduction in ovarian reserve. There is still controversy in the literature regarding whether the cause of the reduction in ovarian reserve is due to damage caused by the coagulation energy during hemostasis or whether the procedure itself is the cause of the damage irrespective of the hemostatic method used. The aim of this study is to compare the effects of different hemostatic methods on the ovarian function of women subjected to laparoscopic surgery for ovarian endometrioma. METHODS: An open-label randomized clinical trial to be conducted at the Lauro Wanderley University Hospital between December 2017 and August 2020. Eighty-four patients will be randomly allocated to three groups according to the hemostatic technique used during laparoscopic surgery for ovarian endometrioma: bipolar coagulation; laparoscopic suture; and hemostatic matrix. Ovarian function will be assessed by serum anti-Müllerian hormone measurement and by performing an antral follicle count using ultrasound before surgery and one, three, and six months after surgery. The internal review board of the Medical Sciences Center, Federal University of Paraíba approved the study protocol under reference CAAE 71621717.9.0000.8069. DISCUSSION: Bearing in mind the need for more randomized clinical trials to clarify this issue, we hope to contribute with data that will determine whether there is any difference between hemostatic methods despite the rational use of bipolar energy or whether the procedure itself explains the ovarian damage irrespective of the hemostatic technique used. TRIAL REGISTRATION: ClinicalTrials.gov, NTC03430609 . Registered on XX.10/31/2017. ISRCTN Registry, ISRCTN11469394 . Registered on XX.17/12/2017. Unique Protocol ID: U1111-1203-2508.

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Condition tags

endometriosisendometrioma

MeSH descriptors

Blood Loss, Surgical Endometriosis Gynecologic Surgical Procedures Gynecologic Surgical Procedures Hemostatic Techniques Hemostatic Techniques Laparoscopy Laparoscopy Ovarian Cysts Ovarian Reserve Anti-Mullerian Hormone Anti-Mullerian Hormone Biomarkers Biomarkers Blood Loss, Surgical Brazil Endometriosis Endometriosis Endometriosis Female

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