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Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM,thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRHa group | Experimental | Patients with fibroid remained will be enrolled and one third of them will be administrated with Zoladex (3.60mg/28 days) for three to six months,. |
|
| mifepristone group | Experimental | Patients with fibroid remained will be enrolled and one third of them will be administrated with mifepristone(10.0mg/d) for three to six months. |
|
| control group | No Intervention | Patients with fibroid remained will be enrolled and the third group was serviced as controls and no drugs will be used. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoladex | Drug | Patients with fibroid remained will be enrolled and divided into three groups. one group wii be administrated with Zoladex (3.60mg/28 days) for three to six months. |
| Measure | Description | Time Frame |
|---|---|---|
| the remaining submucous fibroids volume | The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery; | one to three years after TCRM |
| Measure | Description | Time Frame |
|---|---|---|
| the recurrence rate of remaining submucous fibroids and time | recurrent submucosal fibroids include increased menstrual flow and continued growth of residual submucosal fibroids. | one to three years after TCRM |
| the recurrence time of remaining submucous fibroids |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WU zaigui | Contact | 15957193058 | 411773@zju.edu.cn | |
| RUAN fei | Contact | 057189992125 | 849742095@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Lv weiguo | Women's Hospital School Of Medicine Zhejiang University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| D015735 | Mifepristone |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Mifepristone Oral Tablet | Drug | Patients with fibroid remained will be enrolled and divided into three groups. one group will be administrated with mifepristone(10.0mg/d) for three to six months. |
|
the time interval between recurrent submucosal fibroids and TCRM |
| one to three years after TCRM |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |