The Efficacy and Safety of the Dried Biological Amnion Graft in Patients With Intrauterine Adhesions

Beijing Obstetrics and Gynecology Hospital

Status: Unknown

Conditions: Intrauterine Adhesions

Treatments: Procedure: dried biological amnion graft; Drug: estradiol valerate tablets+dydrogesterone Tablets; Device: Foley balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02496052

zylx201406 (Other Grant/Funding Number)

NO.1-20140601

2014-1-2112 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

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: Single Blind

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300 participants in 2 patient groups

dried biological amnion graft

Experimental group

Description:

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

Treatment:

Device: Foley balloon

Drug: estradiol valerate tablets+dydrogesterone Tablets

Procedure: dried biological amnion graft

Foley catheter balloon only

Sham Comparator group

Description:

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

Treatment:

Device: Foley balloon

Drug: estradiol valerate tablets+dydrogesterone Tablets