Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

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 for the Therapy of Uterine Adhesion

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03346317
• Other study ID #: No.5-20171111
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: November 17, 2017
• Start date: November 16, 2017
• Est. completion date: May 20, 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. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon with amniotic products or estrogen can 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: May 20, 2018
• Est. primary completion date: May 16, 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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

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 amnion membrane 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	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	The 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