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临床试验/NCT04196036
NCT04196036已完成不适用

Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5

Sophie Debrock2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年1月15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
150
试验地点
2
主要终点
cumulative pregnancy rate

研究概览

简要总结

This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.

The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.

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
18 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
  • who are older than 18 and less than 38 years old
  • who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels

排除标准

  • treatment with donor oocytes or donor embryos
  • patients planned for Pre-implantation Genetic Diagnosis (PGD)
  • Patients with BMI>30
  • patients with endometriosis grade III-IV

结局指标

主要结局

cumulative pregnancy rate

时间窗: Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year

The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)

次要结局

  • cost analysis(Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year)

研究者

发起方
Sophie Debrock
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sophie Debrock

Professor, PhD

KU Leuven

研究点 (2)

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