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

Intrauterine Adhesions Clinical Trial

Official title:

The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496052
• Other study ID #: NO.1-20140601
• Secondary ID: 2014-1-2112zylx2
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2015
• Last updated: July 15, 2015
• Start date: January 2013
• Est. completion date: June 2017

Study information

• Verified date: July 2015
• Source: Beijing Obstetrics and Gynecology Hospital
• Contact: Wang Xin, MD
• Phone: 13681401510
• Email: wx_0327[@]126.com
• Is FDA regulated: No
• Health authority: Chile: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Intrauterine Adhesions
• Tissue Adhesions

Intervention

Procedure:
• dried biological amnion graft
Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane

Device:
• Foley balloon
Device: Foley balloon Uterine application of Foley balloon

Drug:
• estradiol valerate tablets+dydrogesterone Tablets
oral estradiol valerate tablets+dydrogesterone Tablets

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Obstetrics and Gynecology Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	second diagnostic hysteroscopy		postoperation three to four months	No