Effectiveness of PGT-A: IVF Versus ICSI
Condition: Genetic Condition
Study type: Observational [Patient Registry]

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): IVF combined with PGT-A; ICSI combined with PGT-A
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): trophectoderm biopsy to test the ploidy state of the IVF embryos; trophectoderm biopsy to test the ploidy state of the ICSI embryos
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population is defined by all couples seeking a fertility treatment due to primary
        or secondary infertility in IVI RMA Abu Dhabi, for non-male factor infertility in
        combination with a PGT-A request.
      
Biospecimen description: 
      Trophectoderm biopsies from human blastocysts to determine the ploidy state
    
Keywords: IVF; ICSI