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

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

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

Study Overview

• Status: Unknown
• Conditions: Intrauterine Adhesions
• Intervention / Treatment: Procedure: dried biological amnion graft; Device: Foley balloon; Drug: estradiol valerate tablets+dydrogesterone Tablets

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Xin, MD; Phone Number: 13681401510; Email: wx_0327@126.com
• Study Contact Backup: Name: Gan Lu, MD; Phone Number: 13552320665; Email: gl19880508@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100006
      • Recruiting
      • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
      • Contact: Liu Zhen, M.D; Phone Number: +8613718210767; Email: fcyykyb@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: dried biological amnion graft; Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane; Other Names: Uterine application of amnion membrane; Device: Foley balloon; Device: Foley balloon Uterine application of Foley balloon; Other Names: Device: Foley balloon Uterine application of Foley balloon; Drug: estradiol valerate tablets+dydrogesterone Tablets; oral estradiol valerate tablets+dydrogesterone Tablets; Other Names: Progynova+dydrogesterone
Sham Comparator: Foley catheter balloon only; patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.	Device: Foley balloon; Device: Foley balloon Uterine application of Foley balloon; Other Names: Device: Foley balloon Uterine application of Foley balloon; Drug: estradiol valerate tablets+dydrogesterone Tablets; oral estradiol valerate tablets+dydrogesterone Tablets; Other Names: Progynova+dydrogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
second diagnostic hysteroscopy	postoperation three to four months

Collaborators and Investigators

• Sponsor: Beijing Obstetrics and Gynecology Hospital
• Investigators: Study Chair: Duan Hua, Ph.D, Beijing Obstetrics and Gynecology Hospital

Publications and helpful links

General Publications

• Amer MI, Abd-El-Maeboud KH. Amnion graft following hysteroscopic lysis of intrauterine adhesions. J Obstet Gynaecol Res. 2006 Dec;32(6):559-66. doi: 10.1111/j.1447-0756.2006.00454.x.
• Gan L, Duan H, Sun FQ, Xu Q, Tang YQ, Wang S. Efficacy of freeze-dried amnion graft following hysteroscopic adhesiolysis of severe intrauterine adhesions. Int J Gynaecol Obstet. 2017 May;137(2):116-122. doi: 10.1002/ijgo.12112. Epub 2017 Mar 1.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): July 17, 2015
• Last Update Submitted That Met QC Criteria: July 15, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: amnion graft; New biological barrier system
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Progestins; Estradiol; Dydrogesterone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate
• Other Study ID Numbers: NO.1-20140601; 2014-1-2112 (Other Grant/Funding Number: The capital health research and development of special); zylx201406 (Other Grant/Funding Number: Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support)