Clinical trial NCT05898321: To Prevent Type I-II Myoma After TCRM Recurrence by Gonadotropin-releasing Hormone (GnRH )Analogues or Mifepristone
Official title: A Multicenter，Prospective Clinical Trial for Reducing Remaining Submucous Fibroids Volume and Preventing Recurrence by Treating With GnRH Analogues or Mifepristone After Transcervical Resection of Type I-II Myoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Submucous Leiomyoma of Uterus
Keywords: Submucous leiomyoma
Transcervical resection of myoma
GnRH analogues
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;
2. Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;
3. Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;
4. A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;
5. Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;
6. Participate in this trial and sign the informed consent form voluntarily .

Exclusion Criteria:

1. Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;
2. Have fertility requirements within 3 years after surgery;
3. Estrogen-dependent diseases such as adenomyosis and endometriosis;
4. Drugs such as mifepristone or GnRHa have been used before surgery;
5. Mifepristone or GnRHa drug treatment is contraindicated or cannot tolerate TCRM surgery.

Primary outcomes:
measure: the remaining submucous fibroids volume
timeFrame: one to three years after TCRM
Secondary outcomes:
measure: the recurrence rate of remaining submucous fibroids and time
timeFrame: one to three years after TCRM
measure: the recurrence time of remaining submucous fibroids
timeFrame: one to three years after TCRM
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Lv weiguo
role: STUDY_DIRECTOR
References: