The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03351205
• Other study ID #: No.6-20171120
• 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
• 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.

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 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