Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
NCT05683041

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Led by University Hospital, Ghent · Updated on 2025-01-27

30

Participants Needed

1

Research Sites

253 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

N

Nordic Pharma SAS

Collaborating Sponsor

AI-Summary

What this Trial Is About

Clinical study on the prevention of intrauterine adhesions after laparoscopic or laparotomic myomectomy. Myomas are common in women of reproductive age and myomectomy can lead to intra-uterine adhesions, which can be detrimental to fertility. This study investigates whether the use of an intrauterine gel can prevent the development of these adhesions.

CONDITIONS

Official Title

Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged between 18 and 45 years
  • Diagnosis of intramural and/or subserosal myoma (FIGO 3-6) or hybrid myoma (FIGO 2-5) scheduled for laparoscopic or laparotomic myomectomy
  • No intra-uterine adhesions confirmed by preoperative diagnostic hysteroscopy
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Laparoscopic or laparotomic myomectomy combined with operative hysteroscopy
  • Presence of endometritis
  • Use of other antiadhesion methods

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Ghent

Ghent, Belgium

Actively Recruiting

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Research Team

S

Steffi Van Wessel, Dr.

CONTACT

S

Steven Weyers, Prof. dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy | DecenTrialz