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临床试验/NCT03428165
NCT03428165已完成不适用

Transfer of Frozen Embryos in NATural Cycle: Evaluation of Impact of Spontaneous Versus HCG-triggered Ovulation on Pregnancy Rate - Bicentric Prospective Open Randomized Controlled Trial

Centre Hospitalier Universitaire de Nīmes4 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2018年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
4
主要终点
Pregnancy rate after transfer of frozen embryos at day 14 between groups

研究概览

简要总结

The purpose of the study is to evaluated whether there is a difference in pregnancy rate when transferring frozen embryos between patietns having spontaneously ovulated versus those triggered to voulate with HCG.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is aged between 18 and 40
  • Patient has regular cycles and classified as 'easy' for transfer of a frozen embryo at blastocyste stage (vitrification day 5)

排除标准

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient using donated oocytes
  • Necessity of pre-implantation diagnosis
  • Patients with stage 3 or 4 endometriosis or adenomyosis

结局指标

主要结局

Pregnancy rate after transfer of frozen embryos at day 14 between groups

时间窗: Day 14

Yes/no; Blood ßHCG \> 100UI/L

次要结局

  • Pregnancy rate at week 12(Week 12)
  • Miscarriage rate within first 12 weeks(Week 12)
  • Cancellation of transfer due to premature ovulation (progesterone >3ng/ml and/or Luteinizing hormone > 3-fold base level)(Day 0)
  • Number of visits for endometrial preparation until attaining LH peak(Day 0)
  • Pregnancy term(At delivery, maximum week 42)
  • Birth weight(At delivery, maximum week 42)
  • Live birth(At delivery, maximum week 42)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (4)

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