10 May, 2004
The publication 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 GONAL F (rFSH, Serono Group) in more than 700 IVF and ICSI patients.
The sub-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 GONAL F group (20%), (p=0.037). (ref 1)
The study analysis also showed that although less oocytes were retrieved in the MENOPUR group vs. GONAL F, MENOPUR appeared to have 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.
To confirm these new results, Ferring is launching a state-of-the-art prospective, multi-national, comparative study powered to demonstrate superiority of MENOPUR vs GONAL F in IVF patients on ongoing pregnancy rate. The study called MERiT will be the largest, international prospective superiority trial comparing MENOPUR vs. GONAL F in IVF.
Included in the state of the art study design and innovative approaches:
- Centralized embryo assessments
- Intrafollicular endocrine environment
- Cryosurvival and frozen embryo cycles
Researchers are confident that the sub-results of EISG will be confirmed with MERiT as MENOPUR provides both FSH activity and LH activity (both of which are important contributors to achieving pregnancy). Several studies conclude that LH activity from either LH or hCG has several positive effects: it stimulates the development of high quality large follicles and it diminishes the number of small follicles which theoretically could reduce the risk of Ovarian Hyperstimulation Syndrome (OHSS). (ref 2)
Interestingly new data also suggests that hCG/LH activity may have a beneficial effect on the blood flow in the endometrium consequently improving the chances of successful egg implantation. (ref3)
According to the sub-analysis, adequate hCG levels during treatment with MENOPUR group appear to have a favourable impact on ongoing pregnancy rates in IVF and ICSI patients, but more markedly in IVF.
The sub-analysis 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 may have real advantages over rFSH (GONAL F) in IVF treatment for infertility,' 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 certain populations. We are confident that our new study MERiT will echo these results. "
EISG Study Details
The EISG1 (European-Israeli Study Group) was an open-label, randomised, multi-center, multinational study to demonstrate non-inferiority of MENOPUR compared to GONAL F on going pregnancy rates
• 727 patients ( HP-hMG:373, rFSH:354)
• Long protocol, down-regulation with GnRH agonist (daily or depot)
• 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
1: The European and Israeli Study Group on Highly Purified menotropin versus Recombinant Follicle-Stimulating Hormone. Fertility and Sterility. 2004 May, 81(5)1401
2: Filicori M et al. Human Reprod Update 2002 Nov-Dec; 8(6): 543-57
3: Licht P. et al. Semin Reprod Med. 2001; 19(1): 37-47.
Ferring is a research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynecology, infertility and urology.
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