跳至主要内容
临床试验/NCT06261671
NCT06261671招募中不适用

Antioxidants-enriched Single-step Vs Global Total Single-step Embryo Culture Media: Effect on Blastocyst Euploidy Rates.

ART Fertility Clinics LLC1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic

研究概览

简要总结

One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

详细描述

Improvements in culture conditions is an ongoing process in IVF due to, on one hand, the still lack of knowledge on human embryonic development, and, on the other hand, the frequent need for repeated IVF cycles to achieve an 'implantable' embryo. The main factor for optimizing conditions of an embryo to develop is its microenvironment, mainly the culture media used. One of the most sensible factors in IVF culture conditions is the susceptibility of gametes and embryos to an induced increase in reactive oxidative species (ROS) caused by the artificial environment, as it has been extensively shown in animal models and to a certain extent in humans.

A primordial step for improvement is to alleviate an increase in ROS during embryo development. This can be manipulated by means of utilizing a culture media with supplements that can serve as scavengers, leading to an equilibrium between oxidation and reduction of ROS during the culture period. So far, the produced culture media contain low concentrations of limited additives involved in anti-oxidative stress. Recently, a culture medium containing an implementation in higher doses of distinctive elements known to clearly serve as cellular scavengers has been formulated. However, very few human IVF studies have been performed up to date. Our research intends to investigate the incorporation of antioxidant-rich culture media into IVF practices with the primary objective of analyzing its impact on embryo euploidy, as well as the previous culture steps including fertilization and blastocyst developmental rates. This study aims to evaluate the impact of using antioxidant-supplemented media during culture to evaluate embryo ploidy rates in a prospective randomized trial using sibling oocytes.

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 43 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing assisted reproductive technology cycles when ICSI is indicated.
  • Patients when Iin vitto fertilization (IVF) is also performed will be included as far as there are enough oocytes for ICSI randomization. However, IVF oocytes will not be used for the study.
  • Maternal age 18-43 years old.
  • PGT-A cycles with only trophectoderm biopsies on day 5/6/
  • Patients with more than 6 COCs expected for ICSI.
  • Body mass index <
  • Fresh and frozen ejaculated sperm.

排除标准

  • PGT-M cycles
  • Fresh and frozen testicular sperm.

研究组 & 干预措施

Group 1: antioxidants-enriched culture medium (Gx)

Active Comparator

Blastocyst exposed to antioxidants-enriched culture medium (Gx) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.

干预措施: antioxidants-enriched culture medium (Gx) (Drug)

Group 2: Global total one step media (GT)

Active Comparator

Blastocyst exposed to Global total one step media (GT) in continuous culture conditions, without refreshment on day 3. A refreshment of the media will be done on D5 in both groups.

干预措施: antioxidants-enriched culture medium (Gx) (Drug)

结局指标

主要结局

Blastocyst ploidy is determined after a biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. The following outcomes are possible: • Normal • Abnormal • No result/Inconclusive • Low or high Mosaic

时间窗: 1 year

Ploidy rate is calculated by dividing the number of normal embryos by the number of blastocysts biopsied in the group.

次要结局

  • Cycle ploidy rate: the number of euploid embryos in the group Blastocyst quality at the time of biopsy based on modified Gardner's criteria. Usable blastocyst rate per group and per day of biopsy (day 5, 6, 7)(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of Antioxydant-enriched Media on Blastocyst... | 临床试验