Evaluation of Chemotherapy Influence on Clinical and Biological Markers of Ovarian Reserve.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- AMH level and antral follicle count
研究概览
简要总结
The objective is to evaluate the influence of chemotherapy, either for auto-immune disease, either for carcinologic disease, on clinical and biological markers of ovarian reserve, for young patients, with normal reproductive functions.
详细描述
The study will enrol patients between 18 and 35 years, treated with neoadjuvant or adjuvant chemotherapy for systemic lupus erythematosus (Group 1), breast cancer (Group 2) or Hodgkin disease (Group 3)to evaluate the clinical and biological markers of ovarian reserve. The follow-up will last 24 months for each patients with a visit before treatment, and at 3 months, 6 months, one year and two years after treatment.
During this period, we will collect pre and post treatment clinical data,and biological data and ultrasonographic data such as antral follicle count which is a marker of ovarian follicle reserve.These data were not observed in current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women volunteers treated by chemotherapy,
- •≥ 18 and ≤ 35 years old
- •Regular menstrual cyclicity, between 25 and 35 days
- •Social security affiliation
- •Signed informed consent
排除标准
- •Women < 18 and > 35 years old
- •Pregnancy
- •Emergent treatment necessity
- •No social security affiliation
- •Virgin patients
结局指标
主要结局
AMH level and antral follicle count
时间窗: one year after the chemotherapy treatment
次要结局
- AMH level and antral follicle count at each visit(3 months, 6 months, and two years after the chemotherapy treatment)
- Hormonal status (Estradiol, LH, FSH and progesterone levels)(3 months, 6 months, and two years after the chemotherapy treatment)
- Menstrual cyclicity(3 months, 6 months, and two years after the chemotherapy treatment)
- pregnancy(3 months, 6 months, and two years after the chemotherapy treatment)
- infertility treatment if required(3 months, 6 months, and two years after the chemotherapy treatment)