NCT03351205

Brief Summary

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2018

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

November 20, 2017

Last Update Submit

November 20, 2017

Conditions

Intrauterine Adhesion

Keywords

Asherman syndromehysteroscopyuterine stentEstrogenAmnionHysteroscopic Adhesiolysis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adhesion information

    Intrauterine adhesions under hysteroscopy

    Within the first 3 months after surgery

Secondary Outcomes (2)

  • Menstruation Pattern

    Within the first 3 months after surgery

  • The change of AFS score

    Within the first 3 months after surgery

Study Arms (2)

Uterine cavity barrier only

EXPERIMENTAL

patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.

Device: disposable balloon uterine stentProcedure: dried biological amnion graft

hormone

EXPERIMENTAL

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

Device: disposable balloon uterine stentProcedure: dried biological amnion graftDrug: estradiol valerate tablets+dydrogesterone tablets

Interventions

disposable balloon uterine stentDEVICE

The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.

Uterine cavity barrier onlyhormone
dried biological amnion graftPROCEDURE

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

Also known as: amnion membrane
Uterine cavity barrier onlyhormone
estradiol valerate tablets+dydrogesterone tabletsDRUG

oral estradiol valerate tablets+dydrogesterone tablets

Also known as: Progynova+dydrogesterone
hormone

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
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, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Duan Hua, MD

    Beijing Obstetrics and Gynecology Hospital

    STUDY CHAIR

Central Study Contacts

Zhu Ru, MD

CONTACT

13966636438zhuru19790202@163.com

Wang Sha, MD

CONTACT

15201556908wangsha1020@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 22, 2017

Study Start

November 21, 2017

Primary Completion

November 21, 2018

Study Completion

November 22, 2018

Last Updated

November 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

CN(1)