Safety and Efficacy of Intrauterine Biological Barrier on Postoperative Adhesion After Hysteroscopic Adhesiolysis
NCT ID: NCT05475756
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
264 participants
INTERVENTIONAL
2022-02-25
2025-05-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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
Intrauterine Biological Barrier
after Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity
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
Intrauterine Adhesion Barrier Gel
after Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* （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
* （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
20 Years
40 Years
FEMALE
No
Sponsors
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Zhangzhou Municipal Hospital of Fujian Province
OTHER
Guangzhou First People's Hospital
OTHER
Tang-Du Hospital
OTHER
Suzhou Municipal Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
Beijing Tiantan Hospital
OTHER
Responsible Party
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Limin Feng
Director of Obstetrics and Gynecology
Principal Investigators
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Limin Feng
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Anhui Provincial Hosptial
Hefei, Anhui, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Guangzhou First people's Hospital
Guangzhou, Guangdong, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Tangdu Hospital
Xi’an, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Ting Gao
Role: primary
Qi Zhang
Role: primary
Feifeng Shi
Role: primary
Hao Zhang
Role: primary
Shunyu Hou
Role: primary
Xifeng Xiao
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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RKM-GPSIS-CTP202201
Identifier Type: -
Identifier Source: org_study_id
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