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Multi-center, randomized trial for evaluation of the efficacy of GnRHa in reducing the recurrence rate of multiple uterine fibroids after myomectomy

GnRHa vs. expectant management in the treatment for multiple leiomyomas after myomectomy: a multicenter, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012992
Enrollment
Unknown
Registered
2017-10-15
Start date
2018-01-08
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple uterine fibroids

Interventions

Group A:None
Group B:Monthly injection of 3.75mg GnRHa for 6 months

Sponsors

Tongji Medical College Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Clinical diagnosis of multiple uterine fibroids (imaging-confirmed); 2.Conservative surgical treatment with pathological diagnosis confirming uterine leiomyoma; 3.Postoperative ultrasound confirming no residual fibroids or fibroid size < 2 cm; 4.Age 18–45 years; 5.First-time treatment (no use of steroid hormones within 3 months prior to treatment); 6.No significant past medical history; 7.Ability to comply with follow-up and good adherence; 8.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Concurrent participation in other drug clinical trials; 2.Patients who are pregnant; 3.Patients with a history of cardiovascular or cerebrovascular accidents, hepatic or renal dysfunction, reproductive tract malformations, breast masses of undetermined nature, or other malignancies; 4.Patients who cannot tolerate surgery; 5.Patients with intolerance or allergy to the drug components.

Design outcomes

Primary

MeasureTime frame
The recurrence time and recurrence rate of uterine fibroids ;

Secondary

MeasureTime frame
Health-related quality of life;Sex hormone test;anti-Müllerian hormone, AMH;CA125;

Countries

China

Contacts

Public ContactWang Shixuan

Tongji Medical College Huazhong University of Science and Technology

SWWANG@TJH.TJMU.EDU.CN+86 27 8366 5614

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026