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临床试验/NCT02068924
NCT02068924Unknown不适用

Single Embryo Transfer: Comparison of Slow Freezing and Vitrification at Blastocyst Stage

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Cumulative delivery rate after fresh and frozen/thawed embryo transfers

研究概览

简要总结

Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.

However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

详细描述

Improvement in the treatment of infertility by Assisted Reproductive Techniques (ART) allows single embryo transfer to be applied without compromising pregnancy rates after the first in vitro fertilization (IVF) or Intra Cytoplasmic Sperm Injection (ICSI) attempt in women less than 36 years old with good embryo quality. The policy of transferring more than one embryo after IVF or ICSI has been the main reason for the numerous twin or triple pregnancies reported in Europe and United States over the past 15 years. These multiple pregnancies are the main disadvantage of ART because of their negative impact on obstetrical, neonatal and economic outcome. In the past, embryos were replaced in the uterus on either Day-2 or 3 of development at the cleavage stage. With the development of physiologically-based sequential culture media, it has also been suggested that extending embryo culture to Day-5 in order to transfer the embryo at the blastocyst stage would enhance the likelihood of pregnancy. Nevertheless, it has been observed higher pregnancy rate after the transfer of fresh blastocyst but not after the transfer of thawed blastocyst frozen by slow freezing procedure.

However a recent embryo freezing technique (vitrification) seems to show significant higher pregnancy rates when blastocyst are frozen by this method. To our knowledge, no publications have reported the outcome of single embryo transfer at blastocyst stage by a prospective randomized and comparative study including the results of fresh and frozen/thawed blastocyst by these two methods (slow freezing vs. vitrification) in case of single embryo transfer .

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

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 36 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • woman < 36 years old
  • first IVF or ICSI attempt with ejaculated sperm
  • at least 5 ovocytes at the pick up
  • at least 3 top embryos at day-2
  • at least one supernumerary blastocyst with good quality at day-5 or day-6

排除标准

  • - woman : FSH >12UI/l
  • ICSI with epididymal or testicular spermatozoa
  • None supernumerary blastocyst with good quality at day-5 or day-6
  • Refuse by the couple to have an embryo transfer at day-5

研究组 & 干预措施

slow freezing

Experimental

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

干预措施: Slow freezing versus vitrification (Other)

vitrification

Other

Therefore, the aim of our study is to analyze whether extended culture of Day-2 top embryos to blastocyst-stage may improve the cumulative delivery rate in an in vitro fertilization program with Single Embryo Transfer policy in a prospective and randomized study integrating the transfer of fresh and frozen/thawed embryos using a slow freezing versus vitrification procedure.

干预措施: Slow freezing versus vitrification (Other)

结局指标

主要结局

Cumulative delivery rate after fresh and frozen/thawed embryo transfers

时间窗: 9 months after embryo transfer

次要结局

  • Delivery rate after transfer of frozen embryos (slow freezing)(9 months after embryo transfer)
  • Neonatal outcome(9 months after embryo transfer)
  • Delivery rate after transfer of frozen embryos (vitrification)(9 months after embryo transfer)
  • Delivery rate after fresh embryo transfer(9 months after embryo transfer)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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