Things we don’t know yet

(a partial listing)

open issues

FertiGen^®

ungelöste themen

1. If I respond to this ‘ovarian reboot’ how long will the effects last? This probably varies by patient, and it is not known how long the improvement in organ function can be sustained after injection. Patient age or baseline AMH doesn’t seem to predict it. However if patients do attain significant improvement in serum AMH we encourage moving to IVF promptly, to take maximum advantage of the measured response.

2. Can any tests forecast the serum AMH “bounce” after FertiGen? Like all aspects of medical practice, there will always be refractory cases showing no response after treatment. But why? One aspect of PRP failure noted by some patients who had PRP elsewhere is that proper counseling & sample processing was either deficient or missing entirely. Our working hypothesis here is that baseline platelet count is the most predictive factor in AMH response.

3. How does FertiGen differ from other ways to attempt ‘ovarian rejuvenation’? Because publications explaining how other clinics perform PRP are so limited, comparisons are impossible for now. When more shared experience becomes available, it will be easier to analyze varied treatment techniques and advance the field. Clinics need to learn from each other, that’s how we improve. 

4. Regarding the registered clinical study on ovarian PRP, any regrets? Yes. The RCT was not designed to include a control group, so no age-matched patients were randomized to receive placebo only. So while our data were descriptively solid, the findings would have been more powerful with this comparison group. Many things have entered standard IVF practice without prospective, placebo-controlled RCT support, however.

5. When enriched platelet factors (EPFs) are considered vs. FertiGen, how do they compare? There are some key similarities, but also important differences. Additional data are needed to differentiate which patients may perform better with each as a first-line intervention. When FertiGen first launched, the number of papers on cell-free EPFs for ovaries was zero. We hope to correct this deficiency soon based on experience with both.

6. Is it known how often to check serum AMH after FertiGen ? No, but it is probably best to evaluate AMH at least monthly following injection. More frequent testing can be considered, but this does add additional cost and hassle for patients. Greater testing frequency would provide closer surveillance on growth factor response, but a statistical comparison has not been carried out on how to optimize this.

7. Could FertiGen help with other reproductive challenges? Maybe. The puzzle of tubal (ectopic) pregnancy has been dangerously unsolved since antiquity. Many deaths still occur worldwide from unrecognized tubal pregnancy, and this cannot be “treated” without ending the pregnancy (to save the mother’s life). But FertiGen might be repurposed to salvage & transpose some of these pregnancies using an immunosurgical technique with platelet-derived growth factors.

Sills & Wood “Figure Five” as published in Journal of Surgery & Transplantation Science 2020;7(1):1072

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