NL-OMON51854尚未招募不适用
on-invasive preimplantation genetic testing (niPGT) - haplotyping by sequencing embryo spent culture medium - non-invasive preimplantation genetic testing (niPGT)
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 317 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 317
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •Group inclusion criteria:
- •To be eligible to participate in this study, a couple must meet all of the
- •following criteria:
- •Couples that have or are carrier of a known severe genetic disorder that choose
- •to do in vitro fertilization (IVF) following preimplantation genetic testing
- •(PGT-IVF). Inclusion criteria of couples are similar to inclusion criteria from
- •PGT that are the following:
- •o The offspring have a high risk on inheriting a severe genetic disorder (as
- •nationally determined by national indication committee); PGT-M.
- •o There is a high risk of miscarriage due to an unbalanced translocation or a
- •high risk of an ongoing pregnancy of a child with an unbalanced translocation
- •Couples meet the requirements for IVF.
- •The comprehensive, sequencing-based haplotyping analysis will be used for
- •analysis of PGT-M
- •The VeriSeq PGS analysis method is used for PGT-SR.
- •Sample inclusion criteria:
- •Oocytes are successfully fertilized and develop into d3 embryos or
- •blastocysts (d5/6/7 embryos).
- •Embryos are successfully biopsied and the conventional PGT result is
- •conclusive.
- •Spent culture medium samples from the PGT-IVF embryos could be collected and
排除标准
- •Group exclusion criteria:
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study.
- •Couples unable to give informed consent to any of the study aspects or unable
- •to comply with the protocol
- •o When participants are < 18 years
- •o Couples that do not speak Dutch will be excluded from participation in this
- •IVF/PGD treatment for a mitochondrial disorder (linked to mtDNA).
- •The analysis of the embryos is done using a day 3 biopsy and subsequent
- •fluorescence in situ hybridization (FISH) analysis.
- •The analysis of the embryo is done using the PCR-based STR marker analysis
- •It is technically not possible to test the preimplantation embryo for the
- •genetic disorder, as determined by the preparation tests for PGT.
- •Sample exclusion criteria:
- •A potential sample who meets any of the following criteria will be excluded
- •from participation in this study.
- •A specific sample will be excluded for analysis when not enough (< 10 µl) or
- •no spent culture medium of the embryo could be collected. In case of no spent
- •culture medium, the other SCM samples from the same PGT couple will still be
研究者
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