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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03351205
Other study ID # No.6-20171120
Secondary ID
Status Recruiting
Phase N/A
First received November 20, 2017
Last updated November 20, 2017
Start date November 21, 2017
Est. completion date November 22, 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. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent,which is an innovative intrauterine balloon,is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.


Description:

Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 22, 2018
Est. primary completion date November 21, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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 compare to Foley catheter.
Procedure:
dried biological amnion graft
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Drug:
estradiol valerate tablets+dydrogesterone tablets
oral estradiol valerate tablets+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 Incidence of adhesion information Intrauterine adhesions under hysteroscopy Within the first 3 months after surgery
Secondary Menstruation Pattern menstrual volume which was assessed by pictorial blood loss assessment chart Within the first 3 months after surgery
Secondary The change of AFS score he American Fertility Society ( AFS ) scoring system (1988 version). Scores of 1-4, 5-8, and 9-12 were mild, moderate, and severe adhesions, respectively. Within the first 3 months after surgery
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