Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysterosco… (NCT05475756) | Clinical Trial Compass
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Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
China264 participantsStarted 2022-02-25
Plain-language summary
To evaluate the safety and efficacy of Intrauterine Biological Barrier developed and produced by Chengdu TopRegMed Medical Technology Co., Ltd on postoperative adhesion after Hysteroscopic Adhesiolysis.
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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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