Protocol for Drug Use Investigation of Follistim Injection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 主要终点
- Occurrence of ovulation
研究概览
简要总结
The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent IVF
排除标准
- •Patients with tumors of ovary, breast, uterus, pituitary or hypothalamus
- •Pregnant or possible pregnant women, or lactating women
- •Patients with undiagnosed atypical vaginal bleeding
- •Patients with a history of hypersensitivity to any of the ingredients of this product
- •Patients with ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease
研究组 & 干预措施
1
Patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction (amenorrhea first grade, anovulatory cycle, polycystic ovary syndrome, oligoamenorrhea) who underwent ovulation induction
干预措施: Follitropin beta (Drug)
结局指标
主要结局
Occurrence of ovulation
时间窗: 3 months, from initiation of treatment to confirmation of pregnancy.
次要结局
- Pregnancy outcome(3 months, from initiation of treatment to confirmation of pregnancy.)