The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

Not Applicable

• Conditions: Intrauterine Adhesions
• Interventions: Device: Foley balloon; Procedure: dried biological amnion graft; Drug: estradiol valerate tablets+dydrogesterone Tablets

• Registration Number: NCT02496052
• Lead Sponsor: Beijing Obstetrics and Gynecology Hospital

Brief Summary

To estimate the efficacy and safety of dried biological amnion graft after hysteroscopic lysis of intrauterine adhesions.

Detailed Description

Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention

Study Timeline

• Study Start: 2013-01
• Status Verified: 2015-07
• Study First Submitted: 2015-07-06
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17
• Primary Completion: 2017-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• age 20-40 years；
• previously diagnostic hysteroscopy confirmed adhesion score >5， according to the American Fertility Society （AFS）classification of IUA；
• complains of menstruation disorder and reproductive dysfunction；
• informed consent.

Exclusion Criteria

• premature menopause,
• presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
• presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
• adhesions limited to the lower uterine cavity or the cervical canal.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Foley catheter balloon only	Foley balloon	patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
dried biological amnion graft	dried biological amnion graft	patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
dried biological amnion graft	Foley balloon	patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
dried biological amnion graft	estradiol valerate tablets+dydrogesterone Tablets	patients, who are with IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Foley catheter balloon only	estradiol valerate tablets+dydrogesterone Tablets	patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Primary Outcome Measures

Name	Time	Method
second diagnostic hysteroscopy	postoperation three to four months

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital，Capital Medical University; 🇨🇳 Beijing, Beijing, China