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

Not Applicable

• Conditions: Intrauterine Adhesion
• Interventions: Device: disposable balloon uterine stent; Procedure: dried biological amnion graft; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets

• Registration Number: NCT03329898
• Lead Sponsor: Beijing Obstetrics and Gynecology Hospital

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. 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

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

Study Timeline

• Study First Submitted: 2017-10-20
• Study Start: 2017-10-31
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17
• Primary Completion: 2018-10-25
• Study Completion: 2018-11-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dried biological amnion graft	dydrogesterone Tablets	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.
dried biological amnion graft	estradiol valerate tablets	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.
disposable balloon uterine stent only	disposable balloon uterine stent	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.
dried biological amnion graft	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.
dried biological amnion graft	disposable balloon uterine stent	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.
disposable balloon uterine stent only	estradiol valerate tablets	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.
disposable balloon uterine stent only	dydrogesterone Tablets	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.

Primary Outcome Measures

Name	Time	Method
second diagnostic hysteroscopy	postoperation three months	American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively

Secondary Outcome Measures

Name	Time	Method
pregnancy	postoperation one year	the number of biochemical pregnancy or clinical pregnancy
Menstruation Pattern	postoperation three months	Amenorrhoea, hypomenorrhea, normal menstrual volume
adhesion reformation	postoperation three months	Adhesion is seen under direct vision by hysteroscopy

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University; 🇨🇳 Beijing, China