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Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

NCT ID: NCT03329898

Last Updated: 2017-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-31

Study Completion Date

2018-11-25

Brief Summary

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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. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.

Detailed Description

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The diaposable balloon uterine(a special intrauterine balloon) is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery. Another group, the diaposable balloon uterin and dried biological amnion will be inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 7th day after surgery.Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

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

Conditions

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Intrauterine Adhesion

Keywords

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Asherman syndrome uterine stent hysteroscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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dried biological amnion graft

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

Group Type EXPERIMENTAL

dried biological amnion graft

Intervention Type PROCEDURE

dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .

disposable balloon uterine stent

Intervention Type DEVICE

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.

estradiol valerate tablets

Intervention Type DRUG

oral estradiol valerate tablets, which can promote endometrial growth after operation.

dydrogesterone Tablets

Intervention Type DRUG

oral dydrogesterone Tablets

disposable balloon uterine stent only

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

Group Type SHAM_COMPARATOR

disposable balloon uterine stent

Intervention Type DEVICE

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.

estradiol valerate tablets

Intervention Type DRUG

oral estradiol valerate tablets, which can promote endometrial growth after operation.

dydrogesterone Tablets

Intervention Type DRUG

oral dydrogesterone Tablets

Interventions

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dried biological amnion graft

dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .

Intervention Type PROCEDURE

disposable balloon uterine stent

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.

Intervention Type DEVICE

estradiol valerate tablets

oral estradiol valerate tablets, which can promote endometrial growth after operation.

Intervention Type DRUG

dydrogesterone Tablets

oral dydrogesterone Tablets

Intervention Type DRUG

Other Intervention Names

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uterine application of amnion membrance Progynova Duphaston

Eligibility Criteria

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Inclusion Criteria

* age 20-45 years.
* previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS).
* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duan Hua, PhD

Role: STUDY_CHAIR

Beijing Obstetrics and Gynecology Hospital

Locations

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Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhu Ru, MD

Role: CONTACT

Phone: 13966636438

Email: [email protected]

Wang Sha, PhD

Role: CONTACT

Phone: 15201556908

Email: [email protected]

Facility Contacts

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Liu Zhen, MD

Role: primary

Other Identifiers

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No.4-20171020

Identifier Type: -

Identifier Source: org_study_id