Intrauterine AdhesionNCT05257213
Heparin Solution Versus Anti-adhesion Barrier Gel for Intrauterine Adhesions Prevention After Operative Hysteroscopy
A study testing Heparin solution and Anti-adhesion barrier gel in people with Intrauterine Adhesion, run by Nadezhda Women's Health Hospital at 2 sites in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Heparin solution and Anti-adhesion barrier gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesBulgaria
- Study dates
- 14 Feb 2022to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- ongoing pregnancy,
- genital cancer,
- pelvic inflammatory disease,
- excessive uterine bleeding.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria2 sites, 2 recruiting
- Recruiting
Nadezhda Women's Health Hospital
Sofia, Sofia, 1330
Georgi Stamenov, MD, 888269839 ext. 359, g.stamenov@abv.bg
Margarita Ruseva, MSc, 889150267 ext. 359, margarita.ruseva@gmail.com
- Recruiting
Nadezhda Women's Health Hospital
Sofia, 1373
Zornitsa Buteva, MD, +359895603362, zornitsa@dr.buteva.com
About this study
Official title: Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy
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.
Read the 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.
- Conditions
- Intrauterine Adhesion
- Being tested
- Heparin solution, Anti-adhesion barrier gel
- Keywords
- operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin solutionDrug
Also called HEP
3 ml saline solution containing 5000 IU heparin.
Anti-adhesion barrier gelDrug
Also called AAB
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).
| Study group | Role | What they receive |
|---|---|---|
| Heparin solution | Active comparator | Administration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy. Receives: Drug: Heparin solution |
| Anti-adhesion barrier gel | Active comparator | Intrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy. Receives: Drug: Anti-adhesion barrier gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 to 8 weeks post treatment
Number of patients with need for subsequent operative hysterectomy
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Measured: 4 tot 8 weeks post treatment
Number of patients with persistent irregular menstrual bleeding
Recurring abnormal menstrual cycle patterns identified post initial surgery
Measured: up to 12 months post treatment
Secondary outcomes (1)
Number of patients with fertility improvement
Successful pregnancy post surgical procedure
Measured: up to 12 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start14 Feb 2022
- Primary completion14 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison between two active intrauterine treatments administered immediately post surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadezhda Women's Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257213
- Sponsor's protocol ID
- 3/11022022
- Status last verified
- May 2025
- First submitted
- 16 Feb 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27173082Valle 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.
PubMed 3381869Nappi 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.
PubMed 17452399van 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.
PubMed 33623830Lee 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.
PubMed 34068335
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Adhesions Prevention: the Use of Heparin Solution Compared to Application of Anti-adhesion Barrier Gel After Operative Hysteroscopy
- ClinicalTrials.gov ID
- NCT05257213
- Acronym / sponsor ID
- 3/11022022
- Conditions
- Intrauterine Adhesion
- Keywords
- operative hysteroscopy, heparin, anti-adhesion barrier gel, intrauterine adhesion, hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nadezhda Women's Health HospitalUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 14 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparison between two active intrauterine treatments administered immediately post surgery
| Arm | Type | Receives |
|---|---|---|
| Heparin solution | Active comparator | Drug: Heparin solutionAdministration of 3 ml heparin solution into the uterine cavity via a syringe immediately post operative hysteroscopy. |
| Anti-adhesion barrier gel | Active comparator | Drug: Anti-adhesion barrier gelIntrauterine application of 2 ml biodegradable anti-adhesion barrier gel immediately post operative hysteroscopy. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- female sex
- indication for operative hysteroscopy including one or more of the following:
- infertility,
- irregular bleeding,
- oligo-/amenorrhea,
Key exclusion criteria (4 listed)
- ongoing pregnancy,
- genital cancer,
- pelvic inflammatory disease,
- excessive uterine bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin solutionAlso: HEP3 ml saline solution containing 5000 IU heparin. | Drug | Heparin solution |
| Anti-adhesion barrier gelAlso: AAB2 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). | Drug | Anti-adhesion barrier gel |
Primary outcome
Number of patients with post-operative intrauterine adhesion formation
Time frame: 4 to 8 weeks post treatment
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
Time frame: 4 tot 8 weeks post treatment
Pathological findings at second-look hysteroscopy taken as indication for successive uterine surgery
Number of patients with persistent irregular menstrual bleeding
Time frame: up to 12 months post treatment
Recurring abnormal menstrual cycle patterns identified post initial surgery
1 secondary outcome
Number of patients with fertility improvement
Time frame: up to 12 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Background: PubMed 27173082Healy 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.
- Background: PubMed 3381869Valle 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.
- Background: PubMed 17452399Nappi 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.
- Background: PubMed 33623830van 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.
- Background: PubMed 34068335Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin solution and Anti-adhesion barrier gel in people with Intrauterine Adhesion, run by Nadezhda Women's Health Hospital at 2 sites in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgi Stamenov (+359888269839, g.stamenov1@abv.bg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with post-operative intrauterine adhesion formation (time frame: 4 to 8 weeks post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05257213, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.