Concurrent Goserelin During Chemotherapy for Ovarian Function Preservation in Premenopausal Breast Cancer: An Open-Label Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Anti-mullerian hormone level
研究概览
简要总结
The purpose of this study is to investigate the benefits of gonadotropin-releasing hormone agonist administration during chemotherapy on preserving ovarian function and Fertility in Premenopausal breast cancer patients, as assessed by anti-mullerian hormone levels, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) levels.
详细描述
The annually estimated number of females diagnosed with cancer is about 6.6 million, 10% of whom are premenopausal.
To minimize the risk of ovarian dysfunction and infertility for these patients, ovarian reserve differs widely from one female to another, but it could be assessed by Ultrasound to reveal antral follicle count (AFC). Also, the hormonal levels of anti-Müllerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone FSH are valuable indicators for fertility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal female patients 18-45 years.
- •Female patients with pathologically confirmed breast cancer and receiving a chemotherapy regimen, either adjuvant or neoadjuvant, containing a gonadotoxic agent.
- •Female patients with performance status (PS) ≤ 2.
排除标准
- •All female Patients with metastatic cancer.
- •Patients underwent total abdominal hysterectomy and bilateral salpingo-oophorectomy, or patients received radiotherapy on the pelvis.
- •Patient with end-organ failure.
- •Patients with performance status >
- •Male with breast cancer.
- •Post-menopausal females.
研究组 & 干预措施
Intervention group
Patients received chemotherapy with concurrent Goserelin 3.6 mg subcutaneously every 28 days
干预措施: Gonadotropin-releasing hormone agonist (Drug)
Control group
Patients received chemotherapy alone.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Anti-mullerian hormone level
时间窗: Immediately post-procedure (Up to 1 hour)
Anti-mullerian hormone level was calculated.
次要结局
- Follicle-stimulating hormone level(Immediately post-procedure (Up to 1 hour))
- Estradiol level(Immediately post-procedure (Up to 1 hour))
- Disease-free survival(2 years post-procedure)
- Overall survival(2 years post-procedure)
研究者
Fatma Mohsen Kamal
Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Helwan, Egypt.
Helwan University