Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT05475756
Eligibility Criteria:
Inclusion Criteria:
* （1）Age, yr20-40 (including boundary value), Female
* （2）Normal ovarian reserve function (FSH\<10U/ml，AMH\>2ng/ml)
* （3）Who suffered from moderate to severe intrauterine adhesions (AFS ≥ 5 points) diagnosed by hysteroscopy, and prepared to be treated by Hysteroscopic adhesiolysis
* （4）Both husband and wife have fertility intention during treatment
* （5）Accept to treatment and follow-up visits, Sign the ICF
Exclusion Criteria:
* （1）Severe systemic diseases, contraindications of surgical and cycle
* （2）Inflammation of reproductive tract, genital tuberculosis, pelvic infection, tumor of reproductive organs
* （3）Systemic diseases cause uterine bleeding
* （4）Allergic to hyaluronic acid or components
* （5）Allergic to swine sources medical device, or refuse to swine sources medical device for religious, ethnic and other reasons
* （6）Insufficient uterine cavity volume after Hysteroscopic adhesiolysis to place Intrauterine Biological Barrier or inject Intrauterine Adhesion Barrier Gel
* （7）Involved other clinical trial before Hysteroscopic adhesiolysis in 3 months or during the trail
* （8）Unable to tolerate anesthesia
* （9）Estrogen medicine was taken within 30 days of Hysteroscopic adhesiolysis
* （10）Other inadequacy patient assessed by the researchers
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT05475756
Study Brief:
Protocol Section:
NCT05475756