NCT03430609: Endometrioma

Ovarian Function After Use of Various Hemostatic Techniques During Treatment for Endometrioma

Active, enrolled NA Last updated 22 July 2020

What this trial tests

NA trial testing Laparoscopic treatment for endometrioma Astus© in Endometriosis Ovary in 38 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2018

Primary endpoint
1 July 2020

31 August 2020

Quick facts

Lead sponsor	Faculdade de Ciências Médicas da Santa Casa de São Paulo
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	1 April 2018
Primary completion	1 July 2020
Estimated completion	31 August 2020
Sites	1 location across Brazil

Drugs / interventions tested

• Laparoscopic treatment for endometrioma Astus©
• AMH Level
• Transvaginal ultrasound for antral follicle count
• Laparoscopic treatment for endometrioma Vicryl®
• Laparoscopic treatment for endometrioma Surgicel®

Conditions studied

• Endometriosis Ovary — all drugs for Endometriosis Ovary →
• Laparoscopy — all drugs for Laparoscopy →
• Ovary; Functional Disturbance — all drugs for Ovary; Functional Disturbance →
• Hemostasis — all drugs for Hemostasis →

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo — full company profile →

Who can join

Adults 18 to 43, female only, with Endometriosis Ovary or Laparoscopy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Endometriosis is defined by the presence of endometrial tissue outside the uterine cavity due to causes not yet fully elucidated. The disease affects approximately 2% of women of reproductive age and is associated with infertility. Approximately 17% to 44% of women with endometriosis exhibit endometrioma, or ovarian endometriosis. Laparoscopic cystectomy is currently considered the gold standard treatment for this problem, resulting in improvement of symptoms, a lower recurrence rate and a higher pregnancy rate among infertile patients. However, several studies have shown that this treatment is not free from risks because it is associated with reduction of the ovarian reserve due to accidental removal of ovarian cortex during stripping of the capsule or damage caused by the coagulation energy during hemostasis, even when performed by experienced surgeons. There is still controversy in the literature as to the cause of the reduction of the ovarian reserve, as the mere presence of endometrioma reduces ovarian function by itself. 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: Open-label randomized clinical trial to be conducted at Lauro Wanderley University Hospital from September 2017 to 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 measuring serum anti-Mullerian hormone and follicle-stimulating hormone levels and by ultrasound antral follicle counts before surgery and 1, 3 and 6 months after surgery. The study was approved by the research ethics committee at the Medical Sciences Center, Federal University of Paraíba CAAE no. 71621717.9.0000.8069.

Discussion: The present study intends to assess the ovarian function of patients with endometrioma subjected to laparoscopic surgical treatment, comparing different hemostatic techniques like bipolar coagulation versus suture versus hemostatic matrix with objective assessments of bipolar coagulation to avoid bias. Thus, the investigators expect to contribute data likely to dispel doubts on the subject.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ovarian function following use of various hemostatic techniques during treatment for unilateral endometrioma: A randomized controlled trial.
   Araujo RSDC, Maia SB, Baracat CMF, Fernandes CQBA, et al · · 2022 · cited 11× · PMID 34478564 · DOI 10.1002/ijgo.13912