The Future of Research and Regulation for Infertility Treatments

PS: What about treatments other than drugs—are they regulated?



KH: Adding sperm and eggs together in any way is not regulated. The procedure most commonly used is intercytoplasmic sperm injection (ICSI), which is injecting a single sperm into a single egg. That procedure, to my knowledge, does not fall under any regulatory system. So ICSI's sort of sitting out there not being regulated.

PS: So is no one overseeing ART?



KH: Not necessarily. If the work is being done at an institution that receives a lot of federal funds, then that research must follow human subject regulations. So, for example, at infertility clinics in major universities like Cornell, experimental ART procedures go through Institutional Review Boards.



PS: But IVF and ICSI and other common practices are standard practice now. Are they considered experimental?



KH: I think there's a fuzzy boundary between research and treatment. IVF was successful in humans before it was successful in animals; ICSI was successful in humans before it was successful in animals.



PS: Despite questions about ART's safety, there seems to be a lot of pressure coming from patients to move forward with research without regulations.



KH: Absolutely. And a number of practitioners and researchers in this field have said, Hey listen, you may say that we need more data, but meanwhile, people are longing for a healthy child. Their biological clocks are going off.



PS: We interviewed a lot of infertile people for this story. None of them knew studies had shown a connection between ART and birth defects. How is that possible? What happened to informed consent?



KH: It's hard to generate a consent form that adequately represents the risks involved given the huge amount of unknowns surrounding those risks. Some might say there's a disincentive for highlighting the risks, because it might mean fewer would use ART.



PS: Do you think informing patients of this risk would change their decision?



KH: It's hard to say. There's data showing that when people are so single-mindedly focused on a goal -- in this case having a child -- risk information doesn't sink in.