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临床试验/NCT01980680
NCT01980680已完成4 期

The Exogenous Progesterone Free Luteal Phase After GnRHa Trigger - a Randomized Controlled Pilot Study in Normo-responder IVF Patients

Peter Humaidan1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年12月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Ongoing pregnancy rate per patient

研究概览

简要总结

After hCG trigger a large amount of exogenous progesterone is used for luteal phase support in many countries until 10th week of gestation. Instead we suggest the use of two small doses of hCG after the trigger during the early luteal phase after GnRHa trigger, promoting the endogenous progesterone production from the corpora lutea (CL).

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
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age between 20 and 40
  • Normal menstrual cycles: 25-34 days
  • Oligomenorrhea/amenorrhea or polycystic syndrome (defined according to the Rotterdam criteria 2004)
  • BMI >18 and <35 kg/m2

排除标准

  • Patients with >14 follicles on day of trigger
  • Previous hyperresponse with OHSS development
  • Previous low response (less than 3 oocytes on a high dose of FSH stimulation)
  • Endocrine disorders

研究组 & 干预措施

Agonist trigger

Experimental

Agonist trigger Buserelin 0,5 mg and Pregnyl (hCG)

干预措施: hCG (Drug)

hCG

Active Comparator

hCG trigger Pregnyl (hCG) and Progesterone and Estradiol

干预措施: Progesterone and Estradiol (Drug)

结局指标

主要结局

Ongoing pregnancy rate per patient

时间窗: 10th week of gestation.

次要结局

未报告次要终点

研究者

发起方
Peter Humaidan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Peter Humaidan

Professor

Regionshospitalet Viborg, Skive

研究点 (1)

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