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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03329898
Other study ID # No.4-20171020
Secondary ID
Status Recruiting
Phase N/A
First received October 20, 2017
Last updated November 14, 2017
Start date October 31, 2017
Est. completion date November 25, 2018

Study information

Verified date November 2017
Source Beijing Obstetrics and Gynecology Hospital
Contact Zhu Ru, MD
Phone 13966636438
Email zhuru19790202@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 25, 2018
Est. primary completion date October 25, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 45 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
dried biological amnion graft
dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
Device:
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.
Drug:
estradiol valerate tablets
oral estradiol valerate tablets, which can promote endometrial growth after operation.
dydrogesterone Tablets
oral dydrogesterone Tablets

Locations

Country Name City State
China Beijing Obstetrics and Gynecology Hospital, Capital Medical University Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Obstetrics and Gynecology Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary second diagnostic hysteroscopy American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively postoperation three months
Secondary pregnancy the number of biochemical pregnancy or clinical pregnancy postoperation one year
Secondary Menstruation Pattern Amenorrhoea, hypomenorrhea, normal menstrual volume postoperation three months
Secondary adhesion reformation Adhesion is seen under direct vision by hysteroscopy postoperation three months
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