跳至主要内容
临床试验/NCT03806153
NCT03806153招募中不适用

Do the Morphokinetic Parameters of Early Embryonic Development Have an Interest in the Choice of the Embryo to be Transferred and Improve Birth Rates in Vitro Fertilization

University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2020年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
520
试验地点
2
主要终点
The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).

研究概览

简要总结

In France, nearly 3% of children are conceived by the technique of Assisted Reproductive Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical pregnancy by oocyte retrieval or embryo transfer have not changed much. The use of mono-embryo transfer reduces the risk of multiple pregnancies and associated obstetric complications. The choice of embryo to transfer or freeze is a key element in improving the chances of success of IVF. It is usually based on conventional morphological criteria (reference method) that are punctual, qualitative and subjective. However, embryo morphology at early stages has little predictive value for obtaining a late-stage embryo and its chances of implantation. The recent use of time-lapse technology during embryonic culture makes it possible to associate morphological criteria with continuous monitoring of the kinetics of embryonic development. The choice of the embryo to be transferred is then made according to morphokinetic criteria (conventional morphological criteria to which are added the data of the kinetics of embryonic development).

Two recent retrospective studies give contradictory results, the first shows higher birth rates in the group of embryos selected according to conventional morphological criteria, the second concludes that morphokinetic analysis is superior. Morphokinetic criteria would also be more objective and reproducible. However, the use of morphokinetic parameters remains controversial in the literature.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For the couple:
  • Couple whose two members are 18 years old and over,
  • Couple whose two members are affiliated to a social security scheme,
  • Couple whose two members read and understood the newsletter and signed the consent form for their participation in this research.
  • For the conditions of realization of the ICSI attempt:
  • Couple supported for a 1st or 2nd attempt at in vitro fertilization with sperm microinjection (ICSI) for male infertility,
  • In vitro fertilization attempt performed with micro-injection of fresh ejaculated spermatozoa.
  • For the man:
  • Couple whose man has an alteration of at least one of the sperm parameters according to the WHO (WHO, 2010) for the number, concentration, vitality, mobility or morphology according to the modified David classification (Auger and Eustache, 2000).

排除标准

  • For the couple:
  • Couple whose wife is under 18 and over 42 and / or the male is under 18 and over 59
  • Couple already included in the protocol "EMCIMO" for a previous attempt,
  • Couple of which one or both members is deprived by an administrative or judicial decision or subject to a legal measure of protection of the majors (safeguard of justice or tutelage or curatorship),
  • Couple where one or both members do not speak or understand French.
  • For the conditions of realization of the ICSI attempt:
  • - In vitro fertilization attempt with the micro-injection of testicular spermatozoa, epididymal, previously frozen or resulting from a retrograde ejaculation.
  • For the man:
  • Severe oligozoospermia (<100,000 spermatozoa / ejaculate).

研究组 & 干预措施

Conventional morphology arm (reference method)

Active Comparator

干预措施: Morphokinetic (Other)

Morphokinetic arm

Experimental

干预措施: Morphokinetic (Other)

结局指标

主要结局

The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).

时间窗: 36 months

次要结局

未报告次要终点

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (2)

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