NCT01331720已完成不适用
Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 279
- 试验地点
- 2
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).
Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) between 18 and 30
- •Prolactin within the laboratory normal range
- •Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- •Patients undergoing Menopur® and/or Bravelle® treatment
- •Normal thyroid function
- •Women not receiving clomifen citrate or gonadotrophins within one month prior study start
- •Couples willing to participate in the study that have signed the informed consent form
排除标准
- •Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
- •Policystic ovarian syndrome
- •Seminal samples not apt for IVF-ICSI (according to the criteria of each center)
- •Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
- •Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
- •Important systemic disease
- •Pregnancy or contraindication to pregnancy
研究组 & 干预措施
FSH:LH 1:1 - Treatment Group A
Patients with a condition
LH (luteinizing hormone)
干预措施: hMG-HP (Drug)
FSH:LH 3:2 - Treatment Group B
Patients with a condition
干预措施: hMG-HP (Drug)
FSH:LH 3:1 - Treatment Group C
Patients with a condition
干预措施: hMG-HP (Drug)
FSH:LH 3:0 - Treatment Group D
Patients with a condition
干预措施: hMG-HP (Drug)
Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E
Patients with a condition
干预措施: hMG-HP (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 0-30 days
次要结局
- Biochemical pregnancy rate(0-16 days)
研究者
研究点 (2)
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