Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Igenomix
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Ongoing Implantation and Pregnancy Rate
研究概览
简要总结
Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis.
This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).
详细描述
The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility&Sterility 2017).
The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ADVANCED AGE and SEVERE MALE FACTOR:
- •Women's Age: 38- 41 years old (both included)
- •Men's Age: 18-60 years old (both included)
- •Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
- •Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
- •Quality of semen: ≥ 5 millions spermatozoids/ml
排除标准
- •ADVANCED AGE and SEVERE MALE FACTOR:
- •Number of Oocytes metaphase II (MII): <5 oocytes
- •Number of Oocytes obtained: >20
- •Estradiol on the day of human chorionic gonadotrophin (hCG) >3000 pgr/ml administration.
- •Progesterone on the day of hCG >1,5 pmol/l administration
- •≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
- •Any un corrected alteration in a previous study.
- •Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.
结局指标
主要结局
Ongoing Implantation and Pregnancy Rate
时间窗: 9 months
次要结局
未报告次要终点
研究者
Carlos Simon
Director of Clinical Research IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA