Clinical trial NCT05475756: Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
Official title: Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis: a Prospective, Multicentre, Randomized, Positive Parallel Controlled, Non-inferiority, Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Endometrium
Adhesion
Postoperative adhesion
Hysteroscopy
Biological Barrier
Adhesion prevention
Infertility
Hysteroscopic Adhesiolysis
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Zhangzhou Municipal Hospital of Fujian Province
name: Guangzhou First People's Hospital
name: Tang-Du Hospital
name: Suzhou Municipal Hospital
name: Anhui Provincial Hospital
First posted: 2022-07-27
Enrollment: 264
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study is a prospective, multicenter, randomized, parallel positive-control, non-inferior clinical trial, with the purpose to evaluate the efficacy and safety of Intrauterine Biological Barrier for the prevention or reduction of intrauterine adhesions after Hysteroscopic Adhesiolysis.

The trial will be conducted at six clinical centers with 264 subjects who meet all the inclusion/ exclusion criteria. Subjects will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Subjects in the test group were treated with Intrauterine Biological Barrier (IBB) made by Chengdu TopRegMed Medical Technology Co. , Ltd. , while the patients in the positive control group were treated with commercially approved Intrauterine Adhesion Barrier Gel for uterine cavity made by Changzhou Bioregen biopharmaceutical Co. , Ltd. .

Subjects will be followed up for 12 months (360 days ± 30 days) after implantation. 73-days (± 12 days) after operation, the safety and effectiveness of IBB will be evaluated by demonstrating non-inferiority to commercially approved gel. If test group is non-inferiority, further study will be performed to explore whether the safety and effectiveness of the IBB is better than the control group in the aspect of the recurrence rate of intrauterine adhesion, types of intrauterine adhesion, postoperative endometrial repair, menstrual recovery and 1-year pregnancy rate.

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

Primary outcomes:
measure: Effective rate
timeFrame: Day 73±12
Secondary outcomes:
measure: Recurrence rate of adhesions
timeFrame: Day 73±12
measure: Extent of uterine adhesions
timeFrame: Day 73±12
measure: Endometrial improvement
timeFrame: Day -7 to day 1, Day 100±10
measure: Time of menstrual recovery
timeFrame: Day 73±12
measure: Duration of Menstrual recovery
timeFrame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
measure: Menstrual blood volume
timeFrame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
measure: Pregnancy rate after operation 1year
timeFrame: Day 360±30
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hosptial
state: Anhui
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First people's Hospital
state: Guangdong
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shanxi
Study officials:
affiliation: Beijing Tiantan Hospital
name: Limin Feng
role: PRINCIPAL_INVESTIGATOR
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