NCT05475756

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

June 7, 2022

Last Update Submit

July 23, 2022

Conditions

Intrauterine Adhesion

Keywords

EndometriumAdhesionPostoperative adhesionHysteroscopyBiological BarrierAdhesion preventionInfertilityHysteroscopic Adhesiolysis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Recurrence rate of adhesions

    Day 73±12

  • Extent of uterine adhesions

    Day 73±12

  • Endometrial improvement

    Day -7 to day 1, Day 100±10

  • Time of menstrual recovery

    Day 73±12

  • Duration of Menstrual recovery

    Day 73±12, Day 100±10 , Day 180±30, Day 360±30

  • +2 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Device: Intrauterine Biological Barrier

Control Group

ACTIVE COMPARATOR

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

Device: Intrauterine Adhesion Barrier Gel

Interventions

Intrauterine Biological BarrierDEVICE

after Hysteroscopic adhesiolysis，use of Intrauterine Biological Barrier to repair uterine cavity

Experimental Group
Intrauterine Adhesion Barrier GelDEVICE

after Hysteroscopic adhesiolysis，use of Intrauterine Adhesion Barrier Gel to repair uterine cavity

Control Group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • （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

You may not qualify if:

  • （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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Anhui Provincial Hosptial

Hefei, Anhui, China

NOT YET RECRUITING

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Zhangzhou Municipal Hospital of Fujian Province

Zhangzhou, Fujian, China

NOT YET RECRUITING

Guangzhou First people's Hospital

Guangzhou, Guangdong, China

NOT YET RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

NOT YET RECRUITING

Tangdu Hospital

Xi’an, Shanxi, China

NOT YET RECRUITING

Related Publications (10)

  • 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.

    PMID: 21549641BACKGROUND

  • 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.

    PMID: 18406834BACKGROUND

  • 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.

    PMID: 3371491BACKGROUND

  • 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.

    PMID: 20014360BACKGROUND

  • 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.

    PMID: 2400752BACKGROUND

  • 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.

    PMID: 28603474BACKGROUND

  • 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.

    PMID: 28723687RESULT

  • 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.

    PMID: 32192600RESULT

  • 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.

    PMID: 23932377RESULT

  • 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.

    PMID: 20576472RESULT

MeSH Terms

Conditions

GynatresiaTissue AdhesionsInfertility

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Limin Feng

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Limin Feng

CONTACT

18911281961Lucyfeng1966@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 7, 2022

First Posted

July 27, 2022

Study Start

February 25, 2022

Primary Completion

May 24, 2024

Study Completion

May 23, 2025

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

No data sharing, only data collection and filling into paper CRF by each site

Locations

CN(6)