Fertinex has been approved as the first highly purified follicle-stimulating hormone (FSH) that can be administered via subcutaneous injection. Fertinex will be marketed for subjects undergoing infertility treatments with Assisted Reproductive Technologies (ART), such as In Vitro Fertilization (IVF), as well as for infertile subjects with polycystic ovary disease (PCO) 1.
Because of its high purity, Fertinex can be self-administered with a very small needle just under the skin (subcutaneous injection), an additional improvement compared to older products which must be injected deep into muscle tissue (intramuscular administration) usually with the aid of the subject's physician, nurse, or partner.
FSH is the primary natural hormone that stimulates development and maturation of follicles, found in the ovaries, which contain oocytes (eggs); during ovulation, egg(s) are released from the follicles. Fertinex stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to affect final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of Fertinex when monitoring of the patient indicates that sufficient follicular development has occurred. There may be a degree of interpatient variability in response to FSH administration.
Infertility affects about 10% of the reproductive-age population in the United States., or about 5.3 million people, according to the American Society for Reproductive Medicine (ASRM). Infertility is commonly defined as the inability to conceive or carry a pregnancy to term, and may be the result of various medical conditions. Infertility affects both the male and female partners equally.