A Phase IV, Prospective, Observational, Open Label, Single Centre Cohort Trial to be Conducted in Norway During One Year to Assess the Cumulative Pregnancy Rate in a New Series of In-vitro Fertilization (IVF) Treatment Cycles Following Three or More Previous IVF Treatment Cycles Without Live Birth.

Since IVF processes were established in 1978, there has been a dramatic increase in the numbers of IVF treatment cycles performed worldwide. In 2003, the total numbers of reported IVF cycles were 132,932 from 725 clinics in 28 European countries, 7,535 IVF/intra cytoplasmic sperm injection (ICSI) cycles from 24 centres in Canada, and over 100,000 IVF cycles from 399 centres in the U.S.

Of all the assisted reproductive technology (ART) procedures available, IVF leads to the highest pregnancy rate per cycle. The degree to which governments reimburse subjects for IVF treatment varies widely among countries in Europe and North America. In Norway, infertile subjects are offered a maximum of three IVF-cycles reimbursed by the government. If three cycles are unsuccessful, subjects must pay for further treatments. This policy might lead subjects to believe that the probability of achieving pregnancy after four or more cycles is very low and, therefore, not worth the cost or effort.

However, a number of published studies show evidence of successful outcomes for additional IVF-cycles after three (or more) cycles with negative results. Many studies show only a modest decline of success with repeated IVF cycles. In addition, a preliminary retrospective analysis of the clinical pregnancy rate in subjects treated at the trial centre during 2007 showed that subjects, who underwent additional one to three IVF-treatment cycles, had a cumulative success rate of 52% (based on clinical experience from 62 subjects at the Hausken clinic in 2007). Thus, these studies indicate that there is a reasonable chance of achieving a healthy pregnancy and live birth after three previous IVF-treatment failures.

In fact, age is likely to be a more important factor than the number of previous IVF treatment failures in determining a successful outcome. Several studies have demonstrated that older women have lower rates of conception and live births, and higher rates of pregnancy failure.

Treatment of subfertility and infertility by ART such as IVF and embryo transfer (ET) requires multiple follicular development to increase the number of female gametes, and the chances of a successful treatment outcome. Ovarian stimulation in IVF/ICSI currently includes suppression of endogenous luteinising hormone (LH) secretion by administration of a gonadotropin releasing hormone (GnRH) analogue, followed by stimulation of multiple follicular development by exogenous follicular stimulating hormone (FSH) administration. When adequate follicular development is achieved, a single dose of human chorionic gonadotropin (hCG) or LH is administered to mimic the endogenous LH surge and induce oocyte maturation.