An interventional study of dried biological amnion graft and disposable balloon uterine stent 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 45 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
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. 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.
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
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 200 is above 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.
dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Procedure: dried biological amnion graft · Device: disposable balloon uterine stent · Drug: estradiol valerate tablets · Drug: dydrogesterone Tablets
disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.
Device: disposable balloon uterine stent · Drug: estradiol valerate tablets · Drug: dydrogesterone Tablets
dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
Also known as: uterine application of amnion membrance
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.
oral estradiol valerate tablets, which can promote endometrial growth after operation.
Also known as: Progynova
oral dydrogesterone Tablets
Also known as: Duphaston
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
Time frame: postoperation three months
pregnancy
the number of biochemical pregnancy or clinical pregnancy
Time frame: postoperation one year
Menstruation Pattern
Amenorrhoea, hypomenorrhea, normal menstrual volume
Time frame: postoperation three months
adhesion reformation
Adhesion is seen under direct vision by hysteroscopy
Time frame: postoperation three months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Oct 2017 (actual). Primary completion is estimated for Oct 2018, 11 months after the start.
Of 46 interventional studies with no phase under Gynatresia, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 77. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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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Beijing Obstetrics and Gynecology Hospital