Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 289
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).
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 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-42 years
- •infertility status
- •Day 3 serum FSH > 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation
排除标准
- •contraindications to infertility treatments or pregnancy
研究组 & 干预措施
High doses
Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
干预措施: GnRH analog and recombinant human FSH (Drug)
Clomid
Administration of Clomiphene Citrate to obtain ovarian follicular growth
干预措施: Clomifene Citrate (Drug)
结局指标
主要结局
live birth rate
时间窗: end of the study (28 months)
general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment. Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy.
次要结局
- ratio pregnancies/costs(end of the study (28 months))