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To verify the influence of potential confounding variables (female age, rank of trial, baseline FSH, stimulation protocol, the total dose of gonadotrophin, days of stimulation, number of cumulus corona cell oocyte complexes retrieved, number of MII obtained) on primary outcomes, logistic regression analysis was conduced.
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Sponsor: The National Institutes of Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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Although oocyte competence with the vitrification procedure appears to have improved, further studies are needed (designed in a prospective way) to determine the efficacy of this approach in the population of infertile patients.
Additionally, GSK is waiting for a decision from Australian Therapeutics Good Administration regarding the regulatory submission for the drug.
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O'Brien JM, Adair CD, Lewis DF, Hall DR, Defranco EA, Fusey S, Soma-Pillay P, Porter K, How H, Schackis R, Eller D, Trivedi Y, Vanburen G, Khandelwal M, Trofatter K, Vidyadhari D, Vijayaraghavan J, Weeks J, Dattel B, Newton E, Chazotte C, Valenzuela G, Calda P, Bsharat M, Creasy GW (2007).
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Gary Dykstra, a professor at the University of Georgia College of Pharmacy who worked for the FDA for 40 years, said that while pharmaceutical compounding started out with clear intentions, it has grown to be a very commercialized enterprise.
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