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临床试验/NCT02145819
NCT02145819已完成4 期

Optimal Planning of a Day 3 Cryopreserved(Frozen)-Thawed Embryo Transfer in a Natural Cycle With hCG Administration or After Spontaneous LH Peak?

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
240
试验地点
1
主要终点
clinical pregnancy rate

研究概览

简要总结

The aim of the study is to determine whether spontaneous LH peak is superior to human chorionic gonadotropin before a transfer of a day 3 frozen embryo.

详细描述

For surplus embryos after fresh IVF-cycles, cryopreservation has become common medical practice. These frozen embryos are mostly replaced in an artificial cycle with exogenous estrogen and progesterone or in a natural cycle. Often, hCG is administered as an ovulation induction agent for scheduling purposes.

Successful implantation requires a co-ordinated series of events allowing a timely dialogue between a receptive endometrium and the intrusive blastocyst . The period of receptivity is thought to be 3 days in human. It is suggested that blastocyst apposition begins about day LH+6 and is completed by day LH+10

In general, the aim is to transfer the embryo during the 'window of implantation', what is defined as the period during which the uterus is receptive for implantation of the free-lying blastocyst. This has been a subject of debate since many years.

A prospective study by Fatemi et al. (2010) revealed a significantly higher ongoing pregnancy rate after transferring frozen-thawed embryos in natural cycles with a spontaneous LH peak compared with natural cycles controlled by hCG for final oocyte maturation and ovulation (31.1% vs. 14.3%, respectively). In this trial, FrET (frozen embryo transfer) was planned 5 days after the LH surge or 5 days after the administration of 5000IU of hCG.

In order to optimize the synchronization in the hCG group, and therefore enhance the pregnancy rates, the aim is to plan a FrET 6 days after hCG administration instead of 5 days. The rationale behind is that day 3 frozen embryos are thawed the day before embryo transfer, which means they are already at day 4 of the embryonic development.

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Natural cycles, in which a frozen-thawed day 3 embryo is replaced.
  • •Signed informed consent.
  • •Regular cycle (i.e. between 26 and 35 days)
  • •Normal transvaginal ultrasound at screening, without evidence of clinically significant abnormality consistent with finding adequate for ART with respect to uterus and adnexa.
  • •Embryos frozen by vitrification.
  • •Single or dual embryo transfer.

排除标准

  • •Known allergic reactions to progesterone products.
  • •Intake of experimental drug within 30 days prior to study start.
  • •Contraindication for pregnancy.
  • •Embryos of women above 39 years of age at the time of embryo freezing.
  • •Recipients of oocyte donation cycles

研究组 & 干预措施

A: spontaneous LH peak

Placebo Comparator

In group A, embryos are thawed 4 days after LH surge, with a re-evaluation and transfer 5 days after LH surge.

干预措施: LH peak (Other)

B: hCG

Active Comparator

In group B, embryos are thawed 5 days after hCG administration, with a re-evaluation and transfer 6 days after hCG.

干预措施: hCG (Drug)

结局指标

主要结局

clinical pregnancy rate

时间窗: 7 weeks

We evaluate the pregnancy, at 7 weeks amenorrhoea. Outcome is clinical pregnancy rate

次要结局

  • number of monitoring visits at the clinic per cycle(7 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arne van de Vijver

Medical Doctor

Universitair Ziekenhuis Brussel

研究点 (1)

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