From idea to clinical reality

This year marks 40 years since the first IVF baby was born. Since then, 8 million babies have been delivered using this transformational technique.

Looking back on how Dr’s Edwards and Steptoe pursued the quest for a successful pregnancy - despite failing over a hundred times - is courageous and remarkable. Few today would consider contemplating such an undertaking, let alone support the project, with less than 1% chance of success.

This gives me a humbling perspective. I am incredibly honored to be chosen to present a plenary session at the FIGO World Congress in October, on how basic science advances are poised to improve Obstetrics/Gynecology and medicine in general, and how Preimplantation Factor (PIF) evolved from idea to clinical reality. 

PIF is pivotal for reproductive success and immune modulation. We showed that ancestral PIF, a small evolutionarily conserved peptide for hundreds of millions of years, is a driving force for successful reproduction.

The discovery of PIF helps to explain why, at the inception of and during pregnancy, the mother’s immune system does not reject the embryo. Rather than being immune suppressive, this process is immune modulatory. Rather than being maternally initiated, this recognition is an embryo-driven, maternal-responsive event. 

The PIF discovery provided pivotal insight into our understanding of mammalian reproduction. PIF, a prime causal factor, is largely responsible for establishing effective embryo-maternal cross talk from two-cell stage prior to implantation and continuing its regulatory function throughout viable pregnancy.

First, we observed that the embryo-secreted PIF regulates maternal immunity, regulates embryo’s acceptance and leads to initial and continued embryo-maternal recognition and acceptance, throughout viable pregnancy.

Using synthetic PIF outside pregnancy led to clinical trials for immune disorders and promoting transplant acceptance. PIF monoclonal antibody-based assays led to the identification of viable IVF embryos and early assessment of high-risk pregnancies.

Ideas are cheap though; others have tried to identify such governing fundamental forces. My wonderful luck is that - surrounded by a stellar and highly supportive group of scientists - we persevered and after more than 10 years, against all odds and technical limitations, ultimately the novel PIF amino acid sequence and its gene were identified. 

We discovered this paradigm-shift by simply observing nature. Having pinpointed PIF’s seminal role in pregnancy, our research reached First-in-Human clinical trial, was awarded Fast-Track status and received Orphan Drug Designation from the Food and Drug Administration (FDA) to determine PIF’s clinical role in treatment of immune disorders and transplant acceptance.

When ideas make true profound sense, though often a paradigm-shift is difficult to achieve, perseverance pays off.

This research should encourage other obstetricians and gynecologists like me to undertake such arduous journeys - if the strong scientific belief is there.

 

This news item has been contributed by:

Eytan R. Barnea, M.D., FACOG
Obstetrician & Gynecologist / Reproductive Endocrinologist
Founder and Chief Scientific Officer, BioIncept, llc
Founder and Chairman of SIEP, the Society for the Investigation of Early Pregnancy

 

Eytan will present at FIGO's World Congress:
Successful embryo-maternal interface: from nature to clinics
October 16, 12:00 PM - 1:00 PM (Room 101A - Hubert de Watteville)

View the full programme