Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis.
Mae Wu Healy, Brian Schexnayder, Matthew T Connell...
https://pubmed.ncbi.nlm.nih.gov/27173082Actively Recruiting
Phase Not Applicable
Age: 25Years - 50Years
FEMALE
ID05257213
Intrauterine Adhesions Prevention: Use of Heparin Solution Compared to Anti-adhesion Barrier Gel After Operative Hysteroscopy
Led by Nadezhda Women's Health Hospital · Updated on 2025-05-21
100
Participants Needed
2
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of intrauterine heparin solution versus anti-adhesion hyaluronic acid barrier gel in preventing intrauterine adhesions following operative hysteroscopy. The study focuses on women undergoing this procedure for conditions such as infertility, irregular bleeding, or uterine abnormalities. The goal is to understand how these treatments impact post-surgical complications and fertility outcomes. Participants will receive one of two treatments immediately after operative hysteroscopy: either 3 ml of heparin solution containing 5000 IU heparin or 2 ml of a biodegradable anti-adhesion barrier gel. Both treatments are applied directly into the uterine cavity. The study uses a randomized design with single masking to compare these interventions. Women will be followed up with a diagnostic hysteroscopy 4 to 8 weeks after surgery to assess the presence and severity of intrauterine adhesions and determine if further surgical treatment is needed. Data on menstrual patterns and pregnancy success will be collected for up to 12 months. Researchers will monitor outcomes such as adhesion formation, irregular bleeding, and fertility improvement during this period.
CONDITIONS
Brief Title
Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
Who Can Participate
Age: 25Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Female sex
- Indication for operative hysteroscopy including infertility, irregular bleeding, oligo-/amenorrhea, Asherman syndrome, fibroids (G0-G3), or dysmorphic uterus
- Age between 25 and 50 years
You will not qualify if you...
- Ongoing pregnancy
- Genital cancer
- Pelvic inflammatory disease
- Excessive uterine bleeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Immediate post-operative period
Participants receive either a heparin solution or an anti-adhesion barrier gel applied into the uterine cavity immediately after operative hysteroscopy to prevent intrauterine adhesions.
1 treatment visit (in-person)
Diagnostic Evaluation
Duration - 4 to 8 weeks post treatment
At 4 to 8 weeks after surgery, participants undergo a follow-up diagnostic hysteroscopy to assess the presence and extent of intrauterine adhesions and identify the need for any further operative procedures.
1 follow-up visit (in-person)
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored for persistent irregular menstrual bleeding and fertility outcomes for up to 12 months following treatment.
Trial Site Locations
Total: 2 locations
1
Nadezhda Women's Health Hospital
Sofia, Sofia, Bulgaria, 1330
Actively Recruiting
2
Nadezhda Women's Health Hospital
Sofia, Bulgaria, 1373
Actively Recruiting
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Research Team
G
Georgi Stamenov
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome.
R F Valle, J J Sciarra
https://pubmed.ncbi.nlm.nih.gov/3381869Prevention of adhesions in gynaecological endoscopy.
C Nappi, A Di Spiezio Sardo, E Greco...
https://pubmed.ncbi.nlm.nih.gov/17452399Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol.
S van Wessel, T Hamerlynck, V Schutyser...
https://pubmed.ncbi.nlm.nih.gov/33623830Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision.
Wen-Ling Lee, Chia-Hao Liu, Min Cheng...
https://pubmed.ncbi.nlm.nih.gov/34068335