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Application of Triptorelin in Preventing Chemotherapy Induced Ovarian Failure in Breast Cancer

Application of Triptorelin in Preventing Chemotherapy Induced Ovarian Failure in Breast Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000980
Enrollment
Unknown
Registered
2010-08-19
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Breast Cancer

Interventions

Placebo control group:Patients randomized to control group will receive their first injection of saline at 0-14 days before start of chemotherapy. Saline will be given as a intramuscular injection eve
Triptorelin group:Patients randomized to Triptorelin will receive their first injection of 3.75 mg at 0-14 days before start of chemotherapy. Triptorelin will be given as a intramuscular injection eve

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 43 Years

Inclusion criteria

Inclusion criteria: 1. Age of at least 18 and at most 43 years; 2. Stage I, II Breast Cancer; 3. with the need for chemotherapy, and the expected survival time of more than 12 months; 4. Written informed consent must be obtained and patients must be available for and compliant to treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. Prior chemotherapy for any reason; 2. Previously received abdominal/pelvic radiation or have planned to receive abdominal/pelvic radiation; 3. Have clinical or biochemical evidence of diminished ovarian reserve; 4. Prior or concomitant malignancy of reproductive system; 5. Allergic to the GnRHa; 6. Other serious illness of heart, brain, respiratory, liver or kidney; 7. Combined with mental illness or cognitive impairment; 8. Pregnant or lactating patients.

Design outcomes

Primary

MeasureTime frame
Ovarian reserve at the end of 6 months after chemotherapy;

Secondary

MeasureTime frame
The percentage of patients with ovarian failure at 5 years after chemotherapy;The percentage of patients with ovarian failure at 2 years after chemotherapy;

Countries

China

Contacts

Public ContactDongZi Yang
yangdz@mail.sysu.edu.cn+86 020 81332257

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026