To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogu… (NCT05898321) | Clinical Trial Compass
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To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone
China294 participantsStarted 2023-06-01
Plain-language summary
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.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion criteria
✓. Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;
✓. Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;
✓. Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;
✓. A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;
✓. Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;
✓. Participate in this trial and sign the informed consent form voluntarily .
Exclusion criteria
✕. Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;
✕. Have fertility requirements within 3 years after surgery;
✕. Estrogen-dependent diseases such as adenomyosis and endometriosis;
What they're measuring
1
the remaining submucous fibroids volume
Timeframe: one to three years after TCRM
Trial details
NCT IDNCT05898321
SponsorWomen's Hospital School Of Medicine Zhejiang University