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临床试验/NCT01331733
NCT01331733已完成不适用

Comparative Assessment of the Clinical Utility of Ovarian Stimulation With Menotropin Versus Menotropin Plus GnRH Antagonist Following Two Protocols of Ovulation Induction for Intrauterine Insemination

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2006年11月最近更新:
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
131
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

To assess the effectiveness of protocols of ovarian hyperstimulation combining urinary gonadotrophins + GnRH antagonist vs urinary gonadotrophins, to achieve clinical pregnancy in females undergoing intrauterine insemination.

Study hypothesis: protocols combining urinary gonadotrophins + GnRH antagonist 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

年龄范围
18 Years 至 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-36 years
  • Body mass index (BMI) between 18 and 26
  • Prolactin within the laboratory normal range
  • Couples affected by sterility able to treat by IUI (intrauterine insemination)
  • Patients undergoing Menopur® treatment
  • Normal thyroid function
  • Regular menses (21-35 days)
  • Couples willing to participate in the study that have signed the informed consent form
  • Seminal sample REM>3 million

排除标准

  • Two previous ART (assisted reproductive technology) cycles without ongoing pregnancy
  • Policystic ovarian syndrome
  • Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months

研究组 & 干预措施

hMG-HP

Patients with a condition

干预措施: hMG-HP (Drug)

hMG-HP + GnRH antagonist

Patients with a condition

干预措施: hMG + GnRH antagonist (Drug)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 30 days

次要结局

  • Live birth rate(40 weeks)

研究者

申办方类型
Industry

研究点 (1)

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