Effectiveness of PGT-A by Using IVF Versus ICSI for Non-male Factor Infertility: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Ploidy state: euploid or aneuploid
研究概览
简要总结
The investigators want to investigate if the use of conventional in vitro fertilization (IVF) can generate more euploid embryos as compared to intracytoplasmic sperm injection (ICSI).
To verify this, the investigators will inject half of the oocytes by ICSI and the other half of the oocytes will be inseminated by conventional IVF. The most important aim is to see if IVF is able to generate more euploid embryos.
详细描述
ICSI is commonly used in pre-implantation genetic testing (PGT) cases to eliminate any risk of sperm DNA contamination. With the switch from cleavage stage biopsy to biopsy of the full (hatching) blastocyst, this potential risk of contamination can be neglected and could allow the use of conventional IVF in PGT cases. Especially in cases of non-male factor infertility, the use of conventional IVF can be applied as a more 'natural' insemination method.
The investigators will perform a pilot study on sibling oocytes including participants with non-male factor infertility and requesting PGT-A (PGT for aneuploidy). If at least 10 cumulus oocyte complexes (COCs) are obtained after oocyte retrieval, half of the oocytes will be subjected to ICSI and the other half to conventional IVF. Preimplantation development is followed by time lapse imaging and blastocysts (day 5-7) fulfilling the biopsy criteria will undergo trophectoderm biopsy to detect the ploidy state and the mitochondrial DNA (mtDNA) copy number.
The main objective is to analyse if the use a more physiological insemination method (IVF) has a beneficial impact on the ploidy state of the blastocyst as compared to ICSI within the same participant. As the embryos will be cultured in a time lapse imaging system, annotations can be made and the differences in maturation rate, fertilization rate and embryo development between both insemination methods can be analysed as secondary outcome parameter. On top of this, the PGT-A outcome will also display the mtDNA copy number which can be compared between IVF and ICSI biopsied sibling blastocyst. Euploid blastocysts will be transferred in subsequent frozen embryo transfer (FET) cycles and give an indication on the clinical outcome between IVF and ICSI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sperm parameters Sperm concentration before capacitation: >15*106 per ml (WHO) Total motility (PR+NP,%): >40 (WHO) Progressive motility (PR,%):>32 (WHO) Sperm concentration after capacitation: >0.6*106 per ml (not WHO defined) Progressive motility (PR,%):>65 (WHO)
- •≥10 COCs after oocyte retrieval
- •BMI ≤30 kg/m2
- •Female age 18 to ≤ 40 years
- •All ovarian stimulation protocols
- •Fresh ejaculates
- •Presence or absence of sperm morphology data: as the investigators do not have a diagnostic sperm analysis for all participants, the presence or absence of >4% normal morphology (WHO) will not be taken into account, even with known low (<4%) normal morphology
- •Couples requesting PGT-A
- •Arab population
排除标准
- •If after denudation (ICSI) only 2 mature oocytes are obtained
- •If all time lapse spaces are occupied
- •If the volume to be added after IVF is insufficient to perform IVF on all needed oocytes
- •Presence of >1 *106 per ml round cells in the ejaculate
- •If a couple's previous cycle was included in the study
结局指标
主要结局
Ploidy state: euploid or aneuploid
时间窗: 7 days
trophectoderm biopsy performed between day 5-7 of preimplantation development. These cells will be genetically tested to see if the correct number of chromosomes are present. Euploid embryos can be used for the patient, aneuploid embryos cannot be used for the patient.
次要结局
- Maturation rate(1 day)
- mitoscore value: ranges from 10-1500(1 day)
- Fertilization rate(1 day)
- Blastulation rate(7 days)
- Embryo development up to day 5(7 days)
- Pregnancy outcome(3 months)
- Morphokinetic development(7 days)
- Embryo development up to day 3(3 days)