Infertility

Infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. Infertility affects approximately 48 million couples worldwide trying to conceive. Estimates suggest that approximately one in every six people of reproductive age worldwide experience infertility in their lifetime. Many factors cause infertility including hormones, structure-physiology of the ovaries, testes, ovulation disorders, low sperm count, endometrioses, polycystic ovary syndrome, diminished ovarian reserve (DOR), and unexplained causes.

The current standard fertility treatment

The current standard of care for infertile women is Controlled ovarian stimulation (COS). COS involves administering hormonal medications to stimulate a woman's ovaries to produce multiple mature eggs during a single menstrual cycle. This process typically starts with the suppression of natural hormonal fluctuations through medications like birth control pills, followed by the use of follicle-stimulating hormone (FSH) and sometimes luteinizing hormone (LH) to encourage the growth and maturation of multiple ovarian follicles. Monitoring via blood tests and ultrasound helps determine the optimal timing for egg retrieval. Once the follicles reach the desired size, a trigger shot of human chorionic gonadotropin (hCG) is administered to induce final maturation, after which the eggs are harvested for use in assisted reproductive techniques like in vitro fertilization (IVF), increasing the chances of successful fertilization and pregnancy.

The need for a new approach

Critical problems in current fertility treatment is they all make use of hormones, and for infertile women to benefit from hormonebased therapies, it is a prerequisite that ovarian follicles have entered the hormone-dependent phase and initiated the maturation process already, as COS treatment is helping secondary follicles to mature into eggs, ready for IVF. For this to happen, it is a prerequisite that enough secondary follicles can mature into high quality eggs, for successful IVF and embryo formation, and ultimately leading to high quality embryo transfer, and a successful pregnancy.

For a large fraction of infertile women, the problem is that the ovarian reserve is limited and thus, these patients do not develop ovarian follicles that would benefit from a COS treatment. Moreover, many infertile patients today undergo numerous IVF treatments, before reaching their goal to become pregnant. The use of COS in IVF adds a lot of physical stress on the body and is associated with numerous side effects, such as changes of ovarian hyperstimulation syndrome, which causes the ovaries to swell and become painful, causing fluids to run into the system, and in severe cases, causes blood clots, shortness of breath, abdominal pain, dehydration, and vomiting are possible. Rare deaths are reported. Moreover, COS/IVF treatment can cause mood depressions and sick leave for the patients.