The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis

Not Applicable

• Conditions: Intrauterine Adhesion
• Interventions: Device: disposable balloon uterine stent; Procedure: dried biological amnion graft; Drug: estradiol valerate tablets+dydrogesterone tablets

• Registration Number: NCT03351205
• Lead Sponsor: Beijing Obstetrics and Gynecology Hospital

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Last Update Submitted: 2017-11-20
• Study Start: 2017-11-21
• Study First Posted: 2017-11-22
• Last Update Posted: 2017-11-22
• Primary Completion: 2018-11-21
• Study Completion: 2018-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hormone	estradiol valerate tablets+dydrogesterone tablets	patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Uterine cavity barrier only	disposable balloon uterine stent	patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
Uterine cavity barrier only	dried biological amnion graft	patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
hormone	dried biological amnion graft	patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
hormone	disposable balloon uterine stent	patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ amnion membrane+hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Primary Outcome Measures

Name	Time	Method
Incidence of adhesion information	Within the first 3 months after surgery	Intrauterine adhesions under hysteroscopy

Secondary Outcome Measures

Name	Time	Method
The change of AFS score	Within the first 3 months after surgery	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.
Menstruation Pattern	Within the first 3 months after surgery	menstrual volume which was assessed by pictorial blood loss assessment chart

Trial Locations

Locations (1)

Beijing Obstetrics and Gynecology Hospital，Capital Medical University; 🇨🇳 Beijing, China