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NCT05475756 Clinical Trial

Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis

Intrauterine Adhesion Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05475756
Other study ID # RKM-GPSIS-CTP202201
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 25, 2022
Est. completion date May 23, 2025

Study information
Verified date July 2022
Source Beijing Tiantan Hospital
Contact Limin Feng
Phone 18911281961
Email Lucyfeng1966@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 264
Est. completion date May 23, 2025
Est. primary completion date May 24, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Intrauterine Biological Barrier
after Hysteroscopic adhesiolysis,use of Intrauterine Biological Barrier to repair uterine cavity
• Intrauterine Adhesion Barrier Gel
after Hysteroscopic adhesiolysis,use of Intrauterine Adhesion Barrier Gel to repair uterine cavity

Locations
Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing
China Guangzhou First people's Hospital Guangzhou Guangdong
China Anhui Provincial Hosptial Hefei Anhui
China Suzhou Municipal Hospital Suzhou Jiangsu
China Tangdu Hospital Xi'an Shanxi
China Zhangzhou Municipal Hospital of Fujian Province Zhangzhou Fujian

Sponsors (6)
Lead Sponsor Collaborator
Beijing Tiantan Hospital Anhui Provincial Hospital, Guangzhou First People's Hospital, Suzhou Municipal Hospital, Tang-Du Hospital, Zhangzhou Municipal Hospital of Fujian Province

Country where clinical trial is conducted

China, 

References & Publications (10)

AAGL Elevating Gynecologic Surgery. AAGL practice report: practice guidelines on intrauterine adhesions developed in collaboration with the European Society of Gynaecological Endoscopy (ESGE). Gynecol Surg. 2017;14(1):6. doi: 10.1186/s10397-017-1007-3. Epub 2017 May 1. — View Citation

Amer MI, Abd-El-Maeboud KH, Abdelfatah I, Salama FA, Abdallah AS. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. J Minim Invasive Gynecol. 2010 Sep-Oct;17(5):605-11. doi: 10.1016/j.jmi — View Citation

Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. — View Citation

Kong D, Zhang L, Xu X, Zhang J, Li Y, Huang X. Small Intestine Submucosa Is a Potential Material for Intrauterine Adhesions Treatment in a Rat Model. Gynecol Obstet Invest. 2018;83(5):499-507. doi: 10.1159/000479086. Epub 2017 Jul 20. — View Citation

Leone FP, Timmerman D, Bourne T, Valentin L, Epstein E, Goldstein SR, Marret H, Parsons AK, Gull B, Istre O, Sepulveda W, Ferrazzi E, Van den Bosch T. Terms, definitions and measurements to describe the sonographic features of the endometrium and intrauterine lesions: a consensus opinion from the International Endometrial Tumor Analysis (IETA) group. Ultrasound Obstet Gynecol. 2010 Jan;35(1):103-12. doi: 10.1002/uog.7487. — View Citation

Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a coho — View Citation

March CM. Management of Asherman's syndrome. Reprod Biomed Online. 2011 Jul;23(1):63-76. doi: 10.1016/j.rbmo.2010.11.018. Epub 2010 Dec 4. Review. — View Citation

The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, müllerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. — View Citation

Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096. Review. — View Citation

Zhang X, Qiu J, Ding Y, Sun L, Hua K. Single port laparoscopy combined with vaginal cervicovaginal reconstruction in a patient with congenital atresia of the cervix. Fertil Steril. 2020 Mar;113(3):681-682. doi: 10.1016/j.fertnstert.2019.11.011. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Effective rate At second-look hysteroscopy after Hysteroscopic adhesiolysis, the effective rate (%) = (number of cured + number of apparent effect)/total number in the group × 100% Day 73±12
Secondary Recurrence rate of adhesions The Presence of adhesions was determined at second-look hysteroscopy after Hysteroscopic adhesiolysis, and the recurrence rate of adhesions (%) = number of adhesion reoccurrence/total number in the group × 100% Day 73±12
Secondary Extent of uterine adhesions The degree of uterine adhesions was assessed intraoperatively and at the second-look hysteroscopy with reference to the ESGE (European Society for Gynecological Endoscopy) criteria Day 73±12
Secondary Endometrial improvement Endometrial thickness in millimeter and change values in millimeter by Ultrasonic Diagnostic Equipment Transvaginal Ultrasonic Probe Head at screening and visit 4 Day -7 to day 1, Day 100±10
Secondary Time of menstrual recovery Time to first menstruation after Hysteroscopic adhesiolysis Day 73±12
Secondary Duration of Menstrual recovery Days of menstrual duration Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Secondary Menstrual blood volume Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC) Day 73±12, Day 100±10 , Day 180±30, Day 360±30
Secondary Pregnancy rate after operation 1year Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100% Day 360±30
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