Infertility is defined by the World Health Organization (WHO) as the inability of a couple to achieve conception or bring a pregnancy to term after one year or more of regular, unprotected sexual intercourse. Infertility affects men and women almost equally. The incidence of subfertility in men and women is almost identical. In 30-40% of the cases, infertility is a female problem, and in approximately 30% of the cases it is exclusively a male problem. In 30% of the cases, both a female and a male are the source of infertility. The cause of the fertility problem remains unexplained in roughly 10-15% of the couples, depending on the diagnostic procedures.

Today, the medical community is addressing the problem of infertility primarily through IVF technology, which was initially developed in 1974 in England. Since that time, we have witnessed the birth of the millionth child born through assisted reproduction techniques (ART). Through the years, several improvements have been made including intracytoplasmic sperm injection (ICSI), pre-implantation genetic diagnosis (PGD), cytoplasmic transfer (CT), and prolonged in vitro culture of embryos until the blastocyst stage (5 days). Each of these improvements has contributed to increasing the IVF cycle success rate, but there is still much room for improvement.

The success of infertility treatments using oral or injectable medication depends on a clinician’s diagnosis of the underlying cause. Once the right diagnosis is made, its therapeutic approach can be chosen. Infertility is mainly caused by a failure of a patient's endocrines situation, therefore the paramount goal of treatment is to remedy this failure. The common therapy today is ART, using various IVF methodologies. These techniques require close monitoring of the development of the maturing ovarian follicle and a repeated estimation of the optimal time point for harvesting the oocyte, done by puncture of the ovarian follicle for extra-corporal fertilization.

Between one and three (or more) of the cultured embryos are transferred back into the uterus of the mother. On average, only 25% of the transferred embryos result in a pregnancy. From those who achieve pregnancy, there is a further reduction to only 20% who actually deliver a healthy baby. This unsatisfactory number is due to multiple problems with implantation and post-implantation steps. In particular, the barely known signaling messages of the pre-implantation embryo (which are the core approach for our product line) are very likely to represent the “gap” necessary to be bridged to significantly improve IVF outcome. The undesirable effect: multiple-fetus pregnancies or multiplet deliveries. The babies are typically in poor physical condition, below the norm weight, and their peri-natal mortality is above average. The hospital expenses to take care of these unfortunate newborns are significant and, in the norm, outweigh the total expense anticipated by reducing the number of IVF cycles. >From the parents’ perspective, the newborns create unexpected financial and emotional hardship.

It is a fact that the current quality and safety of the IVF process is far from optimal. Vitateq’s kit will provide the critical step whereby molecular diagnostic markers for the viability of embryos can be identified. Our diagnostic kit will also enable the evaluation of embryos for their “pregnancy potential.” In addition, Vitateq’s kit will identify karyotypic or chromosomal abnormalities of the embryo in the most critical moment, namely prior to the embryo transfer. Vitateq’s kit will avoid the need to do invasive checks, which require biopsies of the embryo, thus causing discomfort to the mother, a disturbance to embryonic development, and an increased risk of the pregnancy failing. With the utilization of Vitateq’s kit, the physiological, psychological, medical, and financial burdens can be alleviated. The ultimate goal is to provide a more precise pregnancy plan by transferring a single embryo with the highest probability of successful implantation. In the current IVF process, the transfer of only one embryo lowers the pregnancy success rate considerably. It is documented that, with the increasing age of the mothers, the failure rate of pregnancy through IVF methods is very unfavorable. Reasons for this phenomenon include chromosomal aberrations and other biochemical and chemical deteriorations in “old” oocytes.