Clinical trial NCT05257213: 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
Overall status: RECRUITING
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: operative hysteroscopy
heparin
anti-adhesion barrier gel
intrauterine adhesion
hyaluronic acid
Lead sponsor: Nadezhda Women's Health Hospital
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between two active intrauterine treatments administered immediately post surgery
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of patients with post-operative intrauterine adhesion formation
timeFrame: 4 to 8 weeks post treatment
measure: Number of patients with need for subsequent operative hysterectomy
timeFrame: 4 tot 8 weeks post treatment
measure: Number of patients with persistent irregular menstrual bleeding
timeFrame: up to 12 months post treatment
Secondary outcomes:
measure: Number of patients with fertility improvement
timeFrame: up to 12 months post treatment
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Nadezhda Women's Health Hospital
city: Sofia
country: Bulgaria
facility: Nadezhda Women's Health Hospital
Study officials:
References:
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.
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.
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.
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.
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.