Meeting #32, May 9, 2002
The principal goals of this BRMAC discussion are:
determine whether there are data supporting both the safety of and rationale for
ooplasm transfer sufficient to justify the risks of clinical trials with this
technique in humans and
∑ To determine what additional data are needed prior to initiation of clinical trials if sufficient data are not presently available.
Risks to the offspring
∑ Might the procedure damage or alter the oocyte? Concerns include the following:
1. mechanical damage to oocyte cytoarchitecture,
2. inadvertent transfer of chromosomes, chromosome fragments, or other cellular constituents,
3. enhanced survival of abnormal embryos, increasing the likelihood of children born with significant birth defects,
4. risks associated with heteroplasmy
Risks to the mother:
∑ Might risks to the mother be different than those incurred with established ART procedures? For example, the possibility exists that ooplasm transfer might enhance survival of abnormal embryos sufficiently late in gestation to incur additional medical risks to the mother (e.g. late term abortion).
∑ Are there risks to the motherís future fertility or ability to engage in subsequent ART procedures?
∑ What model(s)?
∑ How many generations?
∑ How large will studies need to be to generate meaningful conclusions?
for ooplasm transfer as a means of fertility enhancement
∑ What are appropriate suitability criteria for patient selection for ooplasmic transfer?
∑ What issues are critical to appropriate informed consent? In particular, how will risks to the offspring be considered?
∑ Given that ooplasm transfer causes genetic alteration of the germline, what follow-up of human offspring is appropriate?
∑ What controls are appropriate?