UnknownNot Applicable

Benefit of Hemostatic Sealant in Preservation of Ovarian Reserve

France100 participantsStarted 2023-09-30

Plain-language summary

Introduction : The most common technique used for ovarian cystectomy is the stripping technique. After stripping the cyst wall, the subsequent bleeding of the ovarian stromal wound is usually controlled by bipolar coagulation or/and by suturing. However, hemostasis achieved with bipolar coagulation could result in damage to the ovarian reserve. To avoid damage to healthy ovarian tissue, hemostasis using various topical hemostatic agents has been introduced to control post- cystectomy ovarian wound bleeding. Among these, FloSeal (Baxter Healthcare Corporation, Deer- field, IL, USA) is a hemostatic sealant composed of a gelatin-based matrix and thrombin solution. Aim: The aim of the study is to evaluate the impact of topical hemostatic sealants and bipolar coagulation during laparoscopic ovarian benign cyst resection on ovarian reserve by comparing the rates of decrease in anti- Müllerian hormone (AMH). Methods: A randomized prospective data collection was made on women aged 18-45 years who planned to have laparoscopic ovarian cystectomy at one of two institutions (n = 80), Montpellier University Hospital and Nimes University Hospital, France. Patients were randomly divided into two groups treated with either a topical hemostatic sealant (Floseal) or bipolar coagulation for hemostasis. Preoperative, 3-month and 6-month postoperative AMH levels were checked and the rates of decrease of AMH were compared.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cyst diameter between 3 and 10cm * Preoperative AMH level \>0,5ng/ml * Understanding and acceptance of the protocol Exclusion Criteria: * Post-menopausal status * Any suspicious finding of malignant ovarian disease * Change of contraception method leading to AMH variation * Allergy to bovine products found before inclusion * Pregnancy * Patient who has already participated in the protocol * Person deprived of liberty by judicial or administrative decision * Person protected by law, under tutorship or curatorship * Patient participating in another interventional research on the human person in progress * Refusal of participation after a period of reflection * Patient not affiliated or beneficiary of a national health insurance system

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum anti-Mullerian hormone (AMH) level preoperative

Timeframe: Between 2 and 17 days before cystectomy

Serum anti-Mullerian hormone (AMH) level at 3 months

Timeframe: 3 months after the cystectomy

Serum anti-Mullerian hormone (AMH) level at 6 months

Timeframe: 6 months after the cystectomy

Trial details

NCT IDNCT05037552

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

Contact for this trial

Martha DURAES, MD

+334 67 33 65 32 m-duraes@chu-montpellier.fr

View on ClinicalTrials.gov More Benign Ovarian Cyst trials