Advances in delivery systems for gonadotropins, and specifically the pen/cartridge delivery system for FSH (follicle-stimulating hormone), were the focus of "Managing Great Expectations," a recent program on infertility held in New York City. Sponsored by Organon USA, a division of Akzo Nobel, the event included presentations by Steven D. Spandorfer, M.D., a reproductive endocrinologist affiliated with Cornell University, and Judy Kuriansky, Ph.D., a clinical psychologist.
Pen/cartridge delivery systems, the audience learned, while relatively new to fertility treatment, have been around since the 1980s for treating diabetes and other chronic illnesses. Two prefilled pen/cartridge devices for the injection of FSH are currently marketed: the Follistim AQ Cartridge (follitropin beta injection) from Organon, and Serono's Gonal-f RFF Pen (follitropin alfa injection). Prior to approval of the prefilled versions of FSH, the options for gonadotropin delivery were non-prefilled pens, syringes, ampules, and multidose vials.
When surgery is not an effective option, infertile couples (or individuals) have a variety of pharmacotherapeutic options available. One possible stepwise approach is indicated in the chart below.
Prefilled pens/cartridges offer the following advantages: Fewer number of steps to learn; minimal preparation time, flexible dosing, and self-monitoring of the actual dose.
Recombinant FSH administered by prefilled devices can help induce ovulation prior to natural or artificial insemination and overstimulate the follicles to provide multiple eggs for extraction. Prefilled recombinant FSH devices are not indicated for infertility due to primary ovarian failure, and patients with tubal obstruction should be given these agents only if enrolled in an IVF program.
According to Spandorfer, about six million American couples are affected by infertility, representing about 10% of the reproductive-age population. Forty percent of infertility may be attributed to the woman, 40% to the man, and 10% to both. And in approximately 10% of cases, the exact cause is not known. A variety of factors in the female (including tubal blockage) and in the male (mainly relating to semen motility and viability issues and to erectile dysfunction), as well as unexplained causes in both, can result in infertility.
There were almost 110,000 cycles of assisted reproductive technology in 2001-a 66% increase since 1966. Spandorfer indicated that "a human female fetus will have a peak of six million immature eggs in her ovaries, dropping to about one million at birth, then to 300,000 to 400,000 at puberty and ultimately to zero at menopause."
Said Kuriansky, "The stress associated with the process of conception can have deleterious effects not only on the process but on the couple's relationship." Physiologically, stress impacts the outcome directly due to the negative influence of stress hormones on fertility. Anything that minimizes stress, including a more convenient dosage form for FSH as represented by the pre-filled pen delivery systems, benefits the desired outcome. Industry insiders agree that pre-filled pen/cartridge delivery devices represent a welcome advance and have filled an unmet need for convenience and stress reduction in FSH fertility control therapy.
The author is a clinical writer who resides in northern New Jersey.