Genetic Condition Clinical Trial
Official title:
Effectiveness of PGT-A by Using IVF Versus ICSI for Non-male Factor Infertility: a Pilot Study
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03683277 -
IPD in RRMM Characterized With Genomic Abnormalities of Adverse Prognostic
|
Phase 2 |