The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical Pregnancy Rate
研究概览
简要总结
Basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective of the present study is to explore the relationship between basal serum androgen levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.
详细描述
Design: Single centre, open label, randomized controlled trial.
- Population: Patients with indication of In Vitro Fertilization (IVF) with the following criteria:
- Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te), Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined. All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH + r-LH (225+75 IU/day).
- Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on pregnancy rate (PR) between patients with low and high androgen levels with respect to the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400 patients are to be recruited.
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
- 是
入选标准
- •1st-2nd IVF cycle
- •Regular cycle (25-35 days)
- •Age 18 - 42
- •BMI: 18-29.9
排除标准
- •LH:FSH > 2
- •Low response background (< 5 oocytes)
- •Recurrent pregnancy loss
- •Preimplantational genetic diagnosis indication
- •Any systemic, metabolic or endocrinological disorder.
研究组 & 干预措施
Low androgens FSH+LH
Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
干预措施: FSH+LH (Drug)
High androgens FSH+LH
Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
干预措施: FSH+LH (Drug)
结局指标
主要结局
Clinical Pregnancy Rate
时间窗: 45 days
Use of rec LH supplementation for controlled ovarian stimulation for IVF
次要结局
未报告次要终点
研究者
Ernesto Bosch
Medical Director IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA