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

Intrauterine Adhesion Clinical Trial

Official title:

Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03329898
• Other study ID #: No.4-20171020
• 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
• 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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

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