NCT02496052

Brief Summary

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

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2013

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 17, 2015

Status Verified

July 1, 2015

Enrollment Period

4 years

First QC Date

July 6, 2015

Last Update Submit

July 15, 2015

Conditions

Intrauterine Adhesions

Keywords

amnion graftNew biological barrier system

Outcome Measures

Primary Outcomes (1)

  • second diagnostic hysteroscopy

    postoperation three to four months

Study Arms (2)

dried biological amnion graft

EXPERIMENTAL

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 graftDevice: Foley balloonDrug: estradiol valerate tablets+dydrogesterone Tablets

Foley catheter balloon only

SHAM COMPARATOR

patients, who are with IUA, treated by uterine application of Foley balloon only+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Device: Foley balloonDrug: estradiol valerate tablets+dydrogesterone Tablets

Interventions

dried biological amnion graftPROCEDURE

Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane

Also known as: Uterine application of amnion membrane
dried biological amnion graft
Foley balloonDEVICE

Device: Foley balloon Uterine application of Foley balloon

Also known as: Device: Foley balloon Uterine application of Foley balloon
Foley catheter balloon onlydried biological amnion graft
estradiol valerate tablets+dydrogesterone TabletsDRUG

oral estradiol valerate tablets+dydrogesterone Tablets

Also known as: Progynova+dydrogesterone
Foley catheter balloon onlydried biological amnion graft

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital，Capital Medical University

Beijing, Beijing Municipality, 100006, China

RECRUITING

Related Publications (2)

  • 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: 17100817RESULT

  • 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.

    PMID: 28170094DERIVED

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Duan Hua, Ph.D

    Beijing Obstetrics and Gynecology Hospital

    STUDY CHAIR

Central Study Contacts

Wang Xin, MD

CONTACT

13681401510wx_0327@126.com

Gan Lu, MD

CONTACT

13552320665gl19880508@163.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
SPONSOR

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 14, 2015

Study Start

January 1, 2013

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

July 17, 2015

Record last verified: 2015-07

Locations

CN(1)