Efficiency and Safety Study of Ovarian Stimulation With Letrozole for Fertility Preservation in Breast Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Oocyte maturation rate
研究概览
简要总结
The purpose of this study is to evaluate efficiency and safety of controlled ovarian stimulation (COS) associated with an aromatase inhibitor (letrozole) for fertility preservation in breast cancer patients.
详细描述
Patients enrolled in this study undergo standard or "random start" ovarian stimulation with Gonadotropins using antagonist protocol before the beginning of chemotherapy. Ovulation is triggered in all patients with a GnRH agonist since amendment P2015/091 (Decapeptyl 0,2mg).
At oocyte retrieval, aspirated follicular fluid is separated from the flush medium for hormonal assays, and oocytes are denuded for ICSI(Intra Cytoplasmic Sperm Injection) or vitrification. Cumulus cells are collected for subsequent analysis of oocyte quality gene expression.
A. Primary objective of the study is to evaluate efficiency of letrozole associated ovarian stimulation for fertility preservation in breast cancer patients in terms of oocyte maturation rate.
Patients' results for primary endpoint are prospectively compared to infertile patients undergoing COS without letrozole.
B. Secondary objectives of the study aim to evaluate safety of the protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer female patients of less than 41 years old
- •Addressed to fertility preservation Unit before starting chemotherapy
排除标准
- •Metastatic breast cancer
- •Known premature ovarian failure
- •Basal FSH > 20 IU(International Unit)
- •Surgical contra-indications
研究组 & 干预措施
Letrozole associated COS
Breast cancer patients undergo fertility preservation with letrozole associated COS for oocyte collection.
Letrozole is administered orally (5mg/day) during the entire stimulation protocol until ovulation triggering.
干预措施: Letrozole (Drug)
结局指标
主要结局
Oocyte maturation rate
时间窗: At oocyte collection (48 hours after last administration of letrozole, following COS protocol).
Following letrozole associated COS, oocytes are collected and evaluated for maturation rate (%). These results are prospectively compared to infertile patients undergoing similar COS (GnRH antagonist protocol) without letrozole.
次要结局
- Hormonal levels(during stimulation at ovulation trigger and oocyte retrieval and during luteal phase (days 3 and 8))
- Circulating tumoral DNA(At enrollment (before letrozole associated COS) and at oocyte retrieval (48 hours after last administration of letrozole, following COS protocol))
- Obstetrical outcome: malformation rate(Through study completion: data collection at 2 and 5 years after letrozole associated COS)
- Neonatal outcomes: gestational age at birth(Through study completion: data collection at 2 and 5 years after letrozole associated COS)
- Comparison of breast cancer recurrence rate in patients who underwent letrozole associated COS with an oncological control group(2 and 5 years after letrozole associated COS)
- Ovarian reserve(At enrollment, 2 and 5 years after letrozole associated COS for fertility preservation)
- Neonatal outcomes: delivery procedure(Through study completion: data collection at 2 and 5 years after letrozole associated COS)
- Neonatal outcomes: birth weight(Through study completion: data collection at 2 and 5 years after letrozole associated COS)