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

Beijing Obstetrics and Gynecology Hospital

Status: Unknown

Conditions: Intrauterine Adhesion

Treatments: Procedure: dried biological amnion graft; Device: disposable balloon uterine stent; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03329898

No.4-20171020

Details and patient eligibility

About

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.

Full 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

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

dried biological amnion graft

Experimental group

Description:

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.

Treatment:

Drug: dydrogesterone Tablets

Drug: estradiol valerate tablets

Device: disposable balloon uterine stent

Procedure: dried biological amnion graft

disposable balloon uterine stent only

Sham Comparator group

Description:

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.

Treatment:

Drug: dydrogesterone Tablets

Drug: estradiol valerate tablets

Device: disposable balloon uterine stent