Fertility

A Global Problem

Infertility exists in both male and female reproductive systems, defined by the failure to achieve a pregnancy after at-least 1 year of attempts to become pregnant. According to the World Health Organization, between 48 million couples and 186 million individuals live with infertility, globally.

Leading Approaches for Treating Infertility

Fertilization requires the effectual interactions between a healthy egg (oocyte) and a sperm. In various cases of infertility, numerous assisted reproductive technologies can be employed after other simpler timing, drug administering, and mechanical approaches have been exhausted. Two main methods are used depending on the problem:

IUI – intra-utero-insemination, in which semen is injected into the uterus and fertilization occurs naturally within the woman’s body. High quality semen is needed, i.e., sperm cells with progressive motility and good morphology. Therefore, a technique involving selecting the best sperm cells had been developed.

IVF/ICSI – In-vitro (in the tube) fertilization or intra-cytoplasmatic-sperm injection. In IVF, an oocyte is firstly exposed to multiple motile sperm cells in a petri dish in attempt that a single sperm cell will fertilize the oocyte. In ICSI, the sperm does not have to be motile, and is mechanically injected into the oocyte’s cytoplasm, fertilizing the oocytes. After fertilization occurs at the lab, the embryos are cultured for an additional 2 to 5 days before being transferred into the uterus.

ACC May Aid both Male and Female Fertility

Sperm motility has a calcium ion dependent mechanism. Both sperm and fertilized eggs require physiological pH (a pH that is slightly alkaline) for their optimized performance. However, fertilized eggs and subsequent embryos are exposed to fluctuations in media pH during the culturing period.  ACC provides a controlled stable environment in a slow-release fashion.

In several preclinical trials, ACC added to ram sperm showed increased motility (sperm movement), resulting in more motile sperm available for insemination. The added ACC also improved a critical step, called capacitation, for the ability of the sperm to enter the egg. This is a crucial step, and fertilization will not occur without it.

Hundreds of mice embryos, tested in IVF experiments, exhibited significantly better embryonic development when ACC was added to IVF culture media, and more embryos matured into the blastocysts stage (the last stage before transferring into the uterus). Another set of experiments with female mice demonstrated higher pregnancy rates and a higher number of embryos per mice, after being injected with ACC.

Based on these promising results, Amorphical plans to initiate fertility clinical studies for both males and females, including in-vitro and on-vivo administration approaches.