Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dried biological amnion graft | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent + amnion membrane following hysteroscopic adhesiolysis. |
|
| estrogen | Experimental | patients, who are with IUA, treated by uterine application of disposable balloon uterine stent+ hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable balloon uterine stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adhesion information | Intrauterine adhesions under hysteroscopy | Within the first 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Menstruation pattern | menstrual volume which was assessed by pictorial blood loss assessment chart | Within the first 3 months after surgery |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhu Ru, MD | Contact | 13966636438 | zhuru19790202@163.com | |
| Wang Sha, MD | Contact | 15201556908 | wangsha1020@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Duan Hua, PhD | Beijing Obstetrics and Gynecology Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| dried biological amnion graft | Procedure | Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane |
|
| estradiol valerate tablets+dydrogesterone tablets | Drug | oral estradiol valerate tablets+dydrogesterone tablets |
|
|
| Within the first 3 months after surgery |
| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
Not provided
Not provided