- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05475756
Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Limin Feng
- Phone Number: 18911281961
- Email: Lucyfeng1966@163.com
Study Locations
-
-
Anhui
-
Hefei, Anhui, China
- Not yet recruiting
- Anhui Provincial Hosptial
-
Contact:
- Ting Gao
-
Principal Investigator:
- Ting Gao
-
-
Beijing
-
Beijing, Beijing, China
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Qi Zhang
-
Sub-Investigator:
- Qi Zhang
-
Principal Investigator:
- Limin Feng
-
-
Fujian
-
Zhangzhou, Fujian, China
- Not yet recruiting
- Zhangzhou Municipal Hospital of Fujian Province
-
Contact:
- Feifeng Shi
-
Principal Investigator:
- Feifeng Shi
-
Sub-Investigator:
- Caixia Hong
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Not yet recruiting
- Guangzhou First People's Hospital
-
Principal Investigator:
- Hao Zhang
-
Contact:
- Hao Zhang
-
Sub-Investigator:
- Xiaofeng Zeng
-
-
Jiangsu
-
Suzhou, Jiangsu, China
- Not yet recruiting
- Suzhou Municipal Hospital
-
Contact:
- Shunyu Hou
-
Principal Investigator:
- Shunyu Hou
-
-
Shanxi
-
Xi'an, Shanxi, China
- Not yet recruiting
- Tangdu Hospital
-
Contact:
- Xifeng Xiao
-
Principal Investigator:
- Xifeng Xiao
-
Sub-Investigator:
- Wanlin Zhang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group
Material:Small intestinal submucosa Specifications:A、B、C、D、E Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency:one time after the operation Duration:Single-use
|
after Hysteroscopic adhesiolysis,use of Intrauterine Biological Barrier to repair uterine cavity
|
Active Comparator: Control Group
Material: auto-crosslinked HA gel Specifications: 1 ml, 1.25 ml, 1.5 ml, 1.75 ml, 2 ml, 2.25 ml, 2.5 ml, 2.75 ml, 3 ml, 3.25 ml, 3.75 ml, 4 ml, 4.25 ml, 4.5 ml, 5 ml, 6 ml, 8ml Dosage: investigator selects the specification and quantity(dosage) according to the postoperative uterine cavity volume Frequency:one time after the operation Duration:Single-use
|
after Hysteroscopic adhesiolysis,use of Intrauterine Adhesion Barrier Gel to repair uterine cavity
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effective rate
Time Frame: Day 73±12
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence rate of adhesions
Time Frame: Day 73±12
|
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
|
Extent of uterine adhesions
Time Frame: Day 73±12
|
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
|
Endometrial improvement
Time Frame: Day -7 to day 1, Day 100±10
|
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
|
Time of menstrual recovery
Time Frame: Day 73±12
|
Time to first menstruation after Hysteroscopic adhesiolysis
|
Day 73±12
|
Duration of Menstrual recovery
Time Frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
|
Days of menstrual duration
|
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
|
Menstrual blood volume
Time Frame: Day 73±12, Day 100±10 , Day 180±30, Day 360±30
|
Record and evaluate by Pictorial Blood Loss Assessment Chart (PBAC)
|
Day 73±12, Day 100±10 , Day 180±30, Day 360±30
|
Pregnancy rate after operation 1year
Time Frame: Day 360±30
|
Pregnancy rate (%) = number of pregnancies in the group/total number in the group × 100%
|
Day 360±30
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Limin Feng, Beijing Tiantan Hospital
Publications and helpful links
General Publications
- 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.
- The American Fertility Society classifications of adnexal adhesions, distal tubal occlusion, tubal occlusion secondary to tubal ligation, tubal pregnancies, mullerian anomalies and intrauterine adhesions. Fertil Steril. 1988 Jun;49(6):944-55. doi: 10.1016/s0015-0282(16)59942-7. No abstract available.
- 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. doi: 10.1111/j.1471-0528.1990.tb16249.x.
- 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.
- 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.
- 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. No abstract available.
- 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.
- 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.
- 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 cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
- 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.jmig.2010.03.019. Epub 2010 Jun 23.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RKM-GPSIS-CTP202201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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