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临床试验/NCT01669291
NCT01669291已完成不适用

Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.

Main Line Fertility Center1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2012年7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
发起方
入组人数
43
试验地点
1
主要终点
To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.

研究概览

简要总结

The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.

详细描述

No detailed description

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ages 21-40 (inclusive up to 41)
  • Day 2-4 FSH < or equal to 10
  • Antimullerian Hormone (AMH) greater than or equal to 1.0
  • Between 5 and 20 antral follicles on day 2-4
  • Body Mass Index (BMI)>or equal to 18 and < or equal to 32

排除标准

  • Polycystic Ovarian Disease
  • Endometriosis greater than Stage I
  • Testicular aspirated sperm

研究组 & 干预措施

Bravelle & Menopur Agonist Long Protocol

Active Comparator

Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.

干预措施: Bravelle and Menopur (Drug)

Bravelle & Menopur Agonist Long Protocol

Active Comparator

Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation.

干预措施: Agonist (Drug)

Bravelle & Menopur Antagonist Protocol

Active Comparator

Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.

干预措施: Bravelle and Menopur (Drug)

Bravelle & Menopur Antagonist Protocol

Active Comparator

Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation.

干预措施: Antagonist (Drug)

结局指标

主要结局

To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.

时间窗: One year

次要结局

  • To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist(One year)
  • To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.(One year)

研究者

发起方
Main Line Fertility Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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