Intrauterine Abnormalities in InfertilitySEMFERTILNCT07160764
Safety and Performance of the Semical Adhesion Barrier Gel for Prevention of Intra-uterine Adhesion
An observational study of Intrauterine Abnormalities in Infertility and Asherman Syndrome, run by Semikal Technology at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Abnormalities in Infertility, Asherman Syndrome, Intra-uterine Adhesions
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients ages 18 years and over who are at risk of postoperative adhesion formation after operative hysteroscopy
Who may be able to join
- Female patients aged 18 and over
- Patients who were treated with operative hysteroscopy for intrauterine pathology (endometrial polips, myomas with uterine cavity deformation, uterine septa, intrauterine adhesion, ovarian cyst, endometrial cyst, etc.)
- Patients who had undergone operative hysteroscopy at least 30 days and at most 6 months ago
- Patients who had second-look office hysteroscopy at least once after an operative hysteroscopy
Who cannot join
- Children and adolescents under 18 years of age
- Having a body weight of more than 100 kg
- Surgeries complicated by excessive bleeding; estimated blood loss of more than 100 cc
- Surgeries complicated with uterine perforation
- Presence of uncontrolled diabetes, coagulation disorders, and other severe chronic disorders
- Presence of malignant tumor or diagnosis of cancer, presence of uterovaginal prolapse
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- Concomitant peritoneal grafting or tubal implantation
- Concomitant intrauterine device implantation
- Patients without second-look hysteroscopy
- According to the GDPR and clinical investigation legislation, written informed consent is not mandatory in retrospective studies as long as the patient's personal information is censored.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital Gynecology and Obstetrics Clinic
Antalya, 07100
Burak Karadağ Prof.Dr, 0090 242 249 44 00
Burak Karadağ Prof. Dr.
About this study
Official title: Evaluation of Performance and Safety of Hyalosem Cross-linked Hyaluronic Acid Adhesion Barrier Gel in Preventing Intra-uterine Adhesion Formation After Operative Hysteroscopy: A Retrospective Study
The aim of this study was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation.
Read the detailed description
This study was designed as a non-interventional (observational), comparative, retrospective and single-center study. The investigational device has the CE mark under 93/42/ EEC Medical Device Directive and is used in accordance with the intended use declared by the manufacturer in the user manual. Therefore, the study is a post-marketing clinical follow-up (PMCF) study.
- Conditions
- Intrauterine Abnormalities in Infertility, Asherman Syndrome, Intra-uterine Adhesions, Postoperative Adhesion of Uterus, Asherman's Syndrome
- Keywords
- intrauterine abnormalities, asherman's syndrome, intrauterine adhesions, postoperative adhesions
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cross-linked hyaluronic acid based adhesion barrier gel | Operative hysteroscopy plus adhesion barrier gel | |
| Control group (none) | Operative hysteroscopy alone as control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy
Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy
Measured: 6 months
Secondary outcomes (2)
Improvement in menstrual pattern
from baseline to second look hysteroscopy
Measured: 6 months
Adverse events
Incidence and severity of the adverse events associated with adhesion barrier use
Measured: through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Abnormalities in InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semikal Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Antalya Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160764
- Sponsor's protocol ID
- SEMFERTIL
- Acronym
- SEMFERTIL
- Status last verified
- Sep 2025
- First submitted
- 15 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by locak regulations
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance and Safety of Hyalosem Cross-linked Hyaluronic Acid Adhesion Barrier Gel in Preventing Intra-uterine Adhesion Formation After Operative Hysteroscopy: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07160764
- Acronym / sponsor ID
- SEMFERTIL / SEMFERTIL
- Conditions
- Intrauterine Abnormalities in Infertility, Asherman Syndrome, Intra-uterine Adhesions, Postoperative Adhesion of Uterus, Asherman's Syndrome
- Keywords
- intrauterine abnormalities, asherman's syndrome, intrauterine adhesions, postoperative adhesions
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Semikal TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Antalya Training and Research Hospital
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Sep 2025 (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 was to obtain short- and long-term performance and safety data of cross-linked hyaluronic acid-based adhesion barrier gel used to prevent intrauterine adhesion formation.
Detailed description
This study was designed as a non-interventional (observational), comparative, retrospective and single-center study. The investigational device has the CE mark under 93/42/ EEC Medical Device Directive and is used in accordance with the intended use declared by the manufacturer in the user manual. Therefore, the study is a post-marketing clinical follow-up (PMCF) study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-linked hyaluronic acid based adhesion barrier gel | – | –Operative hysteroscopy plus adhesion barrier gel |
| Control group (none) | – | –Operative hysteroscopy alone as control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients ages 18 years and over who are at risk of postoperative adhesion formation after operative hysteroscopy
Key inclusion criteria (4 listed)
- Female patients aged 18 and over
- Patients who were treated with operative hysteroscopy for intrauterine pathology (endometrial polips, myomas with uterine cavity deformation, uterine septa, intrauterine adhesion, ovarian cyst, endometrial cyst, etc.)
- Patients who had undergone operative hysteroscopy at least 30 days and at most 6 months ago
- Patients who had second-look office hysteroscopy at least once after an operative hysteroscopy
Key exclusion criteria (10 listed)
- Children and adolescents under 18 years of age
- Having a body weight of more than 100 kg
- Surgeries complicated by excessive bleeding; estimated blood loss of more than 100 cc
- Surgeries complicated with uterine perforation
- Presence of uncontrolled diabetes, coagulation disorders, and other severe chronic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy
Time frame: 6 months
Incidence and severity (according to AFS classification) of intrauterine adhesions after operative hysteroscopy identified at follow-up diagnostic hysteroscopy
2 secondary outcomes
Improvement in menstrual pattern
Time frame: 6 months
Adverse events
Time frame: through study completion
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 8 Sep 2025.
- Individual participant dataSharing planned: No. Not allowed by locak regulations
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Abnormalities in Infertility and Asherman Syndrome, run by Semikal Technology at 1 site in Turkey (Türkiye).
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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 Aslıhan Kara Study Director (+90 246 237 01 01, info@semical.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of post-operative intrauterine adhesions at second look hysteroscopy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2025.