Menopur efficacy recognises infertility drug limitations
Menopur, resulted in five more pregnancies per 100 women treated,
compared to current infertility drug treatments, bringing hope to
the 60-80 million couples worldwide affected by infertility.
The news of the latest study results appears to demonstrate better efficacy of the naturally-derived gonadotrophin drug treatment (Menopur) compared to recombinant FSH treatment for controlled ovarian hyperstimulation (COH) in IVF cycles.
Current pharmaceutical treatments for infertility centre around these two methods and demonstrate the positive direction that infertility therapy is taking. However, scientists have acknowledged that much more work needs to be done with this class of drug which has been available and used for decades.
Menopur belongs to a class of drugs known as gonadotrophins and contains both follicle stimulating hormone (FSH) and human chorionic gonadotrophin (HCG) - driven luteinizing activity (LH). It is used to stimulate the development of multiple follicles, especially in women that suffer from anovulation (low-level production of eggs).
At the recent European Society of Human Reproduction and Embryology (ESHRE) in Copenhagen, Denmark, Ferring presented data from its Menotrophin vs. Recombinant FSH in vitro fertilisation Trial (MERiT) that indicated a beneficial influence of LH-activity on ongoing pregnancy rate in IVF cycles (27 per cent with Menopur and 22 per cent with Gonal-F).
According to the World Health Organisation, one in six couples have to seek help to conceive and the problem could be attributed to the rise of infertility to women opting to postpone motherhood until later in life, which often results in age-related infertility.
In the randomised, open-label, assessor-blind, multinational study, a total of 821 women were screened and 731 women were randomised to enter the study. Of these, 363 received Menopur and 368 received recombinant FSH.
Embryo quality was assessed according to rigorous criteria by both the local participating clinic and centrally by a panel of three embryologists blinded to treatment.
According to Dr Johan Smitz from the Follicle Biology Laboratory and Centre for Reproductive Medicine, Free University of Brussels (VUB), Belgium, the human gonadotrophoin (hCG) in Menopur provides a potential breakthrough clue and exciting new science.
"Normal human reproduction depends on the co-ordinated activity of FSH and LH activity. The heightened hCG levels at day six of treatment and the resulting constant LH activity produced by Menopur appears to be an important factor in both embryo quality and pregnancy rates," he said.
Drug treatments for infertility have had the major disadvantage of being horrendously expensive, placing this kind of therapy out of the reach of most people. Clomiphene citrate (commonly called Clomid or Serophene) drugs can cost between $30 (€25) to $75 (€62) per month.
The cost for the injectible drugs (Humegon, Pergonal, Repronex, Fertinex, Follistim and Gonal-F) is high - for one cycle, depending on the drug used, retail pricing and amount prescribed, an injectible cycle can cost between $2,000 (€1660) and $5,000 (€4150). For many infertile couples, taking fertility drugs is a matter of course.
While Clomid works by "tricking" the brain into thinking there is insufficient oestrogen and indirectly stimulating the ovaries, injectibles, which contain FSH (follicle stimulating hormone), directly stimulate the ovaries. Injectables actually contain FSH, so they stimulate the ovaries directly.
Despite the range of infertility drugs available, questions have been asked about which drugs are most effective. Indeed, drug choice and market share may eventually come down to price.
Richard Kennedy, from the Centre for Reproductive Medicine at the University Hospital NHS trust, Coventry, UK told DrugResearcher.com: "From the studies that have investigated infertility drug treatments, there has been no significant efficacy difference between urinary and recombinant FSH drugs."
In the US and the publicly-funded segment of the European market, which are both less sensitive to infertility drug costs, recombinant FSH (follicle stimulating hormone) and recombinant LH (luteinizing hormone) are likely to gain market share at the expense of hMG products and highly purified urinary FSH products.
The two products with the highest sales in the infertility market, Serono's Gonal-F and Organon's Puregon/Follistim, are likely to remain the dominant infertility drugs in the US and much of Europe, although one brands appears to be overtaking the other.
