Traductor

06 July 2011

New study completes a missing piece of the fertilty treatment jigsaw

New data, presented today at the European Society of Human Reproduction and Embryology (ESHRE) meeting, demonstrated the efficacy and tolerability of MENOPUR® (highly purified menotropin) in the Gonadotropin Hormone Releasing Hormone (GnRH) antagonist setting using the infertility treatment technique known as ICSI (Intracytoplasmic Sperm Injection). Results from the MEGASET1 study reinforce the views of fertility experts and provide additional evidence that MENOPUR is effective in all types of assisted reproduction technology (ART) and fertility treatment protocols, completing a missing piece of the fertility treatment jigsaw.

For some years there has been strong evidence of the efficacy of MENOPUR in IVF using long GnRH agonist protocols, including superior live birth rates compared to recombinant follicle-stimulating hormone (rFSH) treatment. However, until now, limited data has been available on the benefits of MENOPUR in GnRH antagonists and ICSI cycles. Current trends in ART are moving toward ICSI as a preferred technique, which is particularly useful in combating male infertility problems . As such, the new MEGASET data add an additional piece to the fertility treatment puzzle as the study was carried out using ICSI technique for fertilisation and stimulation with a GnRH antagonist protocol.

“These results reinforce clinical opinion about the efficacy and tolerability of MENOPUR, and enhance our understanding of effective fertility treatment options” explained Pr Anders Nyboe Andersen, Head of the Fertility Clinic at Copenhagen University Hospital. He continued, “Previous studies have demonstrated that MENOPUR is a high quality and efficient product when used in IVF, and the results from MEGASET will strengthen these perceptions”.

The MEGASET (MENOPUR in GnRH Antagonist Cycles with Single Embryo Transfer) study was initiated as a randomised, multicentre study, and was designed to demonstrate non-inferiority compared to rFSH with respect to ongoing pregnancy rates. The study demonstrated that controlled ovarian stimulation with MENOPUR in a GnRH antagonist protocol gave ongoing pregnancy rates comparable to those achieved with recombinant follitropin beta.

MEGASET recruited women undergoing fertility treatment and compared the efficacy and safety of two different types of ART: highly purified menotropin (MENOPUR, N=374) and rFSH (Puregon, N=375).

MENOPUR was demonstrated to be non-inferior to rFSH with respect to ongoing pregnancy rate for both the intention to treat (ITT) - participants who were randomised and exposed to the investigational medicinal product - and the per protocol (PP) - all participants except those who were excluded because of a major protocol deviation – populations in a GnRH antagonist protocol. The ongoing pregnancy rate was 30% with MENOPUR and 27% with recombinant FSH for the PP population (95% CI of difference: -3.8; 9.8) and 29% and 27% respectively for the ITT population (95% CI of difference: -4.2; 8.6).

In addition, MEGASET revealed that subcutaneous injections of MENOPUR in a new multi-dose formulation have a good safety profile1, 5 and are associated with good local tolerability in patients undergoing controlled ovarian stimulation.

“Around one in seven couples have fertility problems, and infertility can have a profoundly distressing and devastating impact. However, excellent results can be achieved in treating infertility if patients are rapidly investigated and referred for appropriate treatment” explained Sandra Dill, iCSi international patient coalition. “These data will hopefully provide additional information, clarity and confidence to couples navigating the often confusing assisted conception landscape”

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