Table 1

Case studies highlighting issues in some jurisdictions in human reproduction research

Case studyBiosample of interestStakeholders
Case 1: Time lapse imaging and embryo selection
Time-lapse monitoring of embryos versus conventional assessment of embryo morphology for selection for embryo transfer
Principle of study:
Non-invasive monitoring of viable embryos developing in a time-lapse machine unperturbed compared to daily conventional assessment of embryo morphology on reproductive outcomes
Expected outcomes:
Comparison of embryological and clinical data as well as reproductive outcomes from embryos monitored via the time-lapse machine vs conventional morphological assessment using light microscope (done routinely in all IVF labs)
Observing developing embryos continuously using the time lapse machine (already in clinical usage in some countries)
No manipulation of embryos—data gathered are just morphological criteria and demographics of women
IVF team—embryologists, physicians
Patients—comparison of two methods which are done routinely (conventional assessment) and the continuous time lapse monitoring in a machine that has been approved
Case 2: Confirmation of diagnosis of aneuploidy
Confirmation of the karyotype of aneuploid blastocysts (day 5 embryos) identified from trophectoderm biopsy. Aneuploid blastocysts have abnormal no of chromosomes and result in miscarriages and reproductive failure
Principle of study:
Blastocysts tested with preimplantation genetic screening techniques by trophectoderm biopsy to confirm its karyotype by assessing these embryos in totality by disaggregating the embryos—inner cell mass (which gives rise to the embryo) and trophectoderm (gives rise to placenta). This will assess the concordance of analysis of trophectoderm biopsy to the ‘true’ diagnosis of all the cells in these blastocysts
Expected outcomes:
Novel findings in assessing human embryos in totality on the karyotypes of all the cells in these abnormal human embryos. This will reflect on the accuracy of current clinical assessment using trophectoderm biopsy in determining the karyotype of human embryos. It will also suggest novel biological phenomena of embryo division and development.
Abnormal embryos identified as aneuploid, will not be used for any fertility treatments. The embryologists will discard these abnormal embryos in accordance with protocols, applicable legislation and associated provisions.Patients undergoing Assisted Reproductive Therapy (ART)/IVF treatment
Embryologists will perform the procedures and biopsy these embryos
Scientists from the preimplantation genetic diagnostic laboratory will need to analyse the biopsied cells and generate reports to confirm the karyotype of these cells
Clinical coordinators and clinicians would need to follow regulations in counselling and recruiting couples into the study
Case 3: Discarded oocyte research
Understand the mechanisms and biology of immature oocytes as well as unfertilised oocytes of human origins
Principle of study:
This is a ‘futuristic’ study whereby examining these immature and unfertilised oocytes from women undergoing ART allows the in-depth understanding of the plausible mechanisms why oocytes fail to develop during ART and fail to fertilise.
Expected outcomes:
This will allow the discovery of possible causes of failure in oocyte development and ability to fertilise and will identify novel markers for potential therapeutic interventions
Immature oocytes and unfertilised oocytes meant for discarding and never utilised for fertility treatmentWomen who underwent ART and need to perform egg pick ups
Couple must agree together to allow unfertilised oocytes to be donated for research
Embryologists must diagnose immature oocytes and unfertilised oocytes and discard these as per protocols
  • IVF, in vitro fertilisation.