An interventional study of disposable balloon uterine stent and dried biological amnion graft in Intrauterine Adhesion, sponsored by Beijing Obstetrics and Gynecology Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-11-22.
Sponsored by Beijing Obstetrics and Gynecology Hospital · Not applicable, Interventional, and Prevention
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.
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Beijing Obstetrics and Gynecology Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis.
Device: disposable balloon uterine stent · Procedure: 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.
Device: disposable balloon uterine stent · Procedure: dried biological amnion graft · Drug: estradiol valerate tablets+dydrogesterone tablets
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.
Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
Also known as: amnion membrane
Drug pages: Estradiol · Dydrogesterone
oral estradiol valerate tablets+dydrogesterone tablets
Also known as: Progynova+dydrogesterone
Incidence of adhesion information
Intrauterine adhesions under hysteroscopy
Time frame: Within the first 3 months after surgery
Menstruation Pattern
menstrual volume which was assessed by pictorial blood loss assessment chart
Time frame: Within the first 3 months after surgery
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.
Time frame: Within the first 3 months after surgery
Plan to share: Yes
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Estradiol · Dydrogesterone
Beijing Obstetrics and Gynecology Hospital