Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
Primary Purpose
Intrauterine Adhesion
Status
Recruiting
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
Heparin solution
Anti-adhesion barrier gel
Sponsored by
About this trial
This is an interventional prevention trial for Intrauterine Adhesion focused on measuring operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- female sex
- indication for operative hysteroscopy including one or more of the following:
- infertility,
- irregular bleeding,
- oligo-/amenorrhea,
- Asherman syndrome,
- G0-G3 fibroids,
- dysmorphic uterus.
Exclusion Criteria:
- ongoing pregnancy,
- genital cancer,
- pelvic inflammatory disease,
- excessive uterine bleeding.
Sites / Locations
- Nadezhda Women's Health HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Heparin solution
Anti-adhesion barrier gel
Arm Description
Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.
Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.
Outcomes
Primary Outcome Measures
Number of patients with post-operative intrauterine adhesion formation
Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Number of patients with need for subsequent operative hysterectomy
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Number of patients with persistent irregular menstrual bleeding
Recurring abnormal menstrual cycle patterns identified post initial surgery
Secondary Outcome Measures
Number of patients with fertility improvement
Successful pregnancy post surgical procedure
Full Information
NCT ID
NCT05257213
First Posted
February 16, 2022
Last Updated
March 6, 2023
Sponsor
Nadezhda Women's Health Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05257213
Brief Title
Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
Official Title
Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
February 14, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nadezhda Women's Health Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to compare the efficacy of intrauterine application of heparin solution to the use of hyaluronic acid barrier gel for the prevention of intrauterine adhesion formation after operative hysteroscopy.
Detailed Description
In this trial the investigators aim to evaluate and compare the effect of heparin solution to anti-adhesive hyaluronic barrier gel administration immediately after operative hysteroscopy on post-surgical complications (incidence, extent and severity of intrauterine adhesions, abnormal menstrual cycle pattern) and fertility.
Patients undergoing operative hysteroscopy will be identified and invited to participate in the trial. At 4 to 8 weeks after the initial surgery, a follow-up, diagnostic hysteroscopy will be performed to identify indications for subsequent operative procedure and classify intrauterine adhesions according to extent of uterine cavity affected and type of formation found. Data on subsequent persistent irregular menstrual bleeding and pregnancy success up to 12 months following treatment will also be collected.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison between two active intrauterine treatments administered immediately post surgery
Masking
Participant
Masking Description
Patients will be under general anaesthesia during surgical procedure when the allocated treatment will be administered.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heparin solution
Arm Type
Active Comparator
Arm Description
Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy.
Arm Title
Anti-adhesion barrier gel
Arm Type
Active Comparator
Arm Description
Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy.
Intervention Type
Drug
Intervention Name(s)
Heparin solution
Intervention Description
3 ml saline solution containing 5000 IU heparin.
Intervention Type
Drug
Intervention Name(s)
Anti-adhesion barrier gel
Intervention Description
2 ml biodegradable barrier gel containing sodium hyaluronate (10 mg/ml), sodium chloride (8.5 mg/ml), disodium hydrogen phosphate (0.34mg/ml), sodium dihydrogen phosphate (0.14 mg/ml) and water for injection (QS to weight).
Primary Outcome Measure Information:
Title
Number of patients with post-operative intrauterine adhesion formation
Description
Incidence and severity of intrauterine adhesions identified at follow-up diagnostic hysteroscopy as assessed according to Valle and Sciarra's classification of intrauterine synaechia
Time Frame
4 to 8 weeks post treatment
Title
Number of patients with need for subsequent operative hysterectomy
Description
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Time Frame
4 tot 8 weeks post treatment
Title
Number of patients with persistent irregular menstrual bleeding
Description
Recurring abnormal menstrual cycle patterns identified post initial surgery
Time Frame
up to 12 months post treatment
Secondary Outcome Measure Information:
Title
Number of patients with fertility improvement
Description
Successful pregnancy post surgical procedure
Time Frame
up to 12 months post treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
female sex
indication for operative hysteroscopy including one or more of the following:
infertility,
irregular bleeding,
oligo-/amenorrhea,
Asherman syndrome,
G0-G3 fibroids,
dysmorphic uterus.
Exclusion Criteria:
ongoing pregnancy,
genital cancer,
pelvic inflammatory disease,
excessive uterine bleeding.
Facility Information:
Facility Name
Nadezhda Women's Health Hospital
City
Sofia
ZIP/Postal Code
1373
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zornitsa Buteva, MD
Phone
+359895603362
Email
zornitsa@dr.buteva.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27173082
Citation
Healy MW, Schexnayder B, Connell MT, Terry N, DeCherney AH, Csokmay JM, Yauger BJ, Hill MJ. Intrauterine adhesion prevention after hysteroscopy: a systematic review and meta-analysis. Am J Obstet Gynecol. 2016 Sep;215(3):267-275.e7. doi: 10.1016/j.ajog.2016.05.001. Epub 2016 May 10.
Results Reference
background
PubMed Identifier
3381869
Citation
Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. doi: 10.1016/0002-9378(88)90382-1.
Results Reference
background
PubMed Identifier
17452399
Citation
Nappi C, Di Spiezio Sardo A, Greco E, Guida M, Bettocchi S, Bifulco G. Prevention of adhesions in gynaecological endoscopy. Hum Reprod Update. 2007 Jul-Aug;13(4):379-94. doi: 10.1093/humupd/dml061. Epub 2007 Apr 23.
Results Reference
background
PubMed Identifier
33623830
Citation
van Wessel S, Hamerlynck T, Schutyser V, Tomassetti C, Wyns C, Nisolle M, Verguts J, Colman R, Weyers S, Bosteels J. Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol. Hum Reprod Open. 2021 Feb 16;2021(1):hoab001. doi: 10.1093/hropen/hoab001. eCollection 2021.
Results Reference
background
PubMed Identifier
34068335
Citation
Lee WL, Liu CH, Cheng M, Chang WH, Liu WM, Wang PH. Focus on the Primary Prevention of Intrauterine Adhesions: Current Concept and Vision. Int J Mol Sci. 2021 May 13;22(10):5175. doi: 10.3390/ijms22105175.
Results Reference
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Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
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