January 22, 2004
The new data was based on a sub-analysis of the landmark trial EISG (European-Israeli Study Group) which was designed to demonstrate non-inferiority of MENOPUR* (HP-hMG) when compared with rFSH * in nearly 700 IVF and ICSI patients.
Further analysis showed impressive results: the ongoing pregnancy rate in the 233 women who underwent IVF was significantly higher in the MENOPUR group (31%) compared with the rFSH group (20%), (p=0.037) . - a difference of 50%.
The results from the study which were published in an abstract at the American Society for Reproductive Medicine in October 2003, were presented in more depth today at the Updates in Infertility Congress in Marco Island, Florida. The study analysis also showed that although fewer oocytes were retrieved in the MENOPUR group vs. rFSH group, MENOPUR had a clear beneficial effect on the pregnancy rates in women undergoing IVF.
IVF procedures make up more than 60 percent of all ART (assisted reproduction treatment) procedures.
The conclusions from this analysis will be confirmed in a state-of-the-art prospective, multi-national, comparative study powered to demonstrate superiority of MENOPUR vs rFSH in IVF patients. The trial will be launched next month.
Researchers are confident that the results of EISG will be confirmed as MENOPUR and that LH activity will be an important contributor to pregnancy. Several studies conclude that the LH activity/hCG has several positive effects: it stimulates the development of high quality large follicles and it diminishes the number of small follicles which hypothetically could reduce the risk of Ovarian Hyperstimulation Syndrome (OHSS).
Interestingly new data also suggests that LH/HhCG activity may have a beneficial effect on the blood flow in the endometrium consequently improving the chances of successful egg implementation.
Adequate hCG levels during treatment with MENOPUR appear to have a favourable impact on ongoing pregnancy rates in IVF and ICSI patients, but more markedly in IVF.
The authors suggest that the beneficial effect of the LH activity in MENOPUR seen in IVF patients could also be mediated by "cumulus oophorus" cells which are present during the IVF and not during the ICSI procedure.
"It is becoming increasingly evident that MENOPUR will challenge and will likely replace rFSH in the treatment of infertility with IVF,' said Dr. Pascal Danglas, vice-president of Clinical and Product Development at Ferring. ''Studies like this are important because they provide evidence to identify the gonadotropin most likely to work best in which procedure. With the result of the new study, MENOPUR must be considered one of the most effective treatments in IVF therapy today. "
"And from a patient's perspective this is also big news. What this means is that with MENOPUR, you have a higher chance of pregnancy if your procedure is IVF, he said.
EISG Study Details
The EISG (European-Israeli Study Group) was an open-label, randomised, multi-center, multinational study to demonstrate non-inferiority of HP-hMG compared to rFSH on going pregnancy rates
• Patient's: In this study, 727 women were exposed to gonadotrophin treatment, of whom 691 had either IVF (n = 233) or ICSI (n = 458) performed.
• Intervention: Three-hundred and seventy-three women received HP-hMG (Menopur®, Ferring Pharmaceuticals A/S) and 354 received rFSH (Gonal-F®, Serono) according to a long protocol with a GnRH agonist.
• HP-hMG (MENOPUR) vs rFSH (GONAL-F), subcutaneous route
• IVF/ICSI and embryo transfer procedures according to center practice. Transfer of 1-3 developed embryos.
• Luteal support according to center practice
Infertility on the Rise
Globally, 14% of couples are facing problems with infertility and the number is increasing, mainly because many women are opting to postpone motherhood. In the group of 30-35 year olds, the infertility rate increases to 25%. One third of births are by women above 30 years of age.
Today, reproductive medicine offers a variety of procedures to assist couples in achieving pregnancy, but more than half of the couples with more than two years of infertility still fail to achieve pregnancy. With advances in infertility research and wider availability of newer techniques, the success rate of infertility treatment is rising but there is a continuous need for new and more effective treatments.
• MENOPUR is a registered trademark of Ferring BV and/or one of its affiliates.
• GONAL-F is a registered trademark of Serono.
Ferring is a research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynecology, infertility and urology. In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.
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