Efficiency of Amnion Graft to Prevent Intrauterine Adhesions After Hysteroscopic Surgery

NCT02132104 | Unknown DMC

• 1 other identifier: CMU-FXH-14-06
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to evaluate whether human amnion graft reduces the reformation of severe intrauterine adhesions (IUA) following hysteroscopic adhesiolysis.

Conditions

Intrauterine Adhesions

Keywords

Intrauterine adhesions; Asherman Syndrome; Amnion graft

Outcome Measures

Primary Outcomes (1)

• safety of intrauterine application of amnion membrane

  patients treated by amnion membrane following their hysteroscopic procedure were followed for immediate and late adverse effect: fever, abnormal vaginal discharge, pelvic pain, increased intrauterine adhesion formation upon follow up and changes in menstrual pattern.

  3 months

Secondary Outcomes (1)

• efficacy of intrauterine application of amnion graft in reducing adhesion formation following hysteroscopic adhesiolysis.

  3 months

Study Arms (2)

amnion graft in severe IUA

EXPERIMENTAL

patients, who are with severe IUA, treated by uterine application of amnion membrane + Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.

Procedure: Uterine application of amnion membrane; Device: Foley balloon; Drug: Femoston

non-amnion graft in severe IUA

SHAM COMPARATOR

patients, who are with severe IUA, treated by Foley balloon+ hormones (Femoston) following hysteroscopic adhesiolysis.

Device: Foley balloon; Drug: Femoston

Interventions

Uterine application of amnion membrane PROCEDURE

Uterine application of amnion membrane following hysteroscopic adhesiolysis.

Also known as: Human amnion membrane

amnion graft in severe IUA

Foley balloon DEVICE

Uterine application of Foley balloon

amnion graft in severe IUA; non-amnion graft in severe IUA

Femoston DRUG

Hormones treatment after surgery.

Also known as: Hormones

amnion graft in severe IUA; non-amnion graft in severe IUA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients scheduled for adhesiolysis of intrauterine adhesions
• patients willing to undergo followed hysteroscopy about 4 and 12 weeks after the surgery to assess the reformation of intrauterine adhesions.
• Written, informed consent obtained.

You may not qualify if:

• ongoing pregnancy
• Peroperative fever or infections
• Malignancy
• Precious pelvic inflammatory disease
• Uterine fibroid (\>3cm size)
• endometriosis
• Contraindications for anesthesia
• Not able to read and/or understand informed consent.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (2)

Fu Xing Hospital, Capital Medical University

Beijing, 100038, China

Location

Fu Xing Hospital, Capital Medical University

Beijing, 100038, China

Location

Related Publications (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.

  PMID: 18406834 BACKGROUND

• 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: 20576472 BACKGROUND

• 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.

  PMID: 17100817 BACKGROUND

• 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: 3371491 BACKGROUND

MeSH Terms

Conditions

Gynatresia

Interventions

femoston; Hormones

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• TC Li, PhD

  Hysteroscopic Center, Fu Xing Hospital

  STUDY DIRECTOR

• Xuebing Peng, MD

  Hysteroscopic Center, Fu Xing Hospital

  PRINCIPAL INVESTIGATOR

• Enlan Xia, MD

  Hysteroscopic Center, Fu Xing Hospital

  STUDY CHAIR

Central Study Contacts

Xuebing Peng, MD

CONTACT

008613901297392; peng_xue_bing@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 7, 2014
• Study Start: November 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 21, 2014

Record last verified: 2014-10

Locations

CN (2)