Great progress has been made in the management of female infertility since the introduction of assisted reproductive technology, predominantly in vitro fertilisation (IVF). However, despite the improvements made in the space, challenges associated with the treatment remain. The development of non-injectable fertility medications represents a significant unmet need, according to key opinion leaders (KOLs) interviewed by GlobalData.
Dr Shireen Mohammad, Senior Cardiovascular & Metabolic Disorders Analyst at GlobalData, comments, “KOLs have described the level of unmet need in this market as moderate. While injectable gonadotropins are commonly used in IVF, they require subcutaneous or intramuscular injections, which can be inconvenient, painful, and stressful for patients. Therefore, the development of non-injectable alternatives could offer significant benefits in terms of patient convenience, compliance, and the overall treatment experience.”
Linzagolix choline, developed by Kissei Pharmaceutical, is an orally administered gonadotropin-releasing hormone (GnRH) receptor antagonist currently in Phase III clinical trials in the US, France, and Spain. It is promising as a non-injectable alternative for female infertility. Patient-friendlier progesterone administration for luteal phase support is another unmet need in the female infertility market.
Intramuscular progesterone is associated with considerable pain and local reactions at the site of injection, whereas patients often experience undesirable side effects with vaginal forms such as vaginal leakage. Subcutaneous progesterone, developed by IBSA Institut Biochemique and marketed as Prolutex, offers a significant advantage over traditional intramuscular progesterone injections by addressing the common issue of injection-related pain.
Mohammad continues, “Treating poor responders is another unmet need in female infertility, as poor responders are women who have a reduced ovarian response to ovarian stimulation during IVF treatment. These patients often face lower success rates and higher treatment dropouts compared to normal responders.
“Novel treatments targeting poor responders are crucial to improving their chances of achieving a successful pregnancy. Furthermore, while IVF has advanced significantly, there are still areas for improvement. This includes improving embryo selection methods and increasing success rates in older women and those with diminished ovarian reserve (DOR).”
There is a need for more affordable and accessible fertility treatments, as well as expanded insurance coverage and financial support programs to help alleviate the financial burden associated with infertility treatment.
“Addressing these unmet needs could significantly improve the success rates of infertility treatments, enhancing the chances of successful pregnancies and improving the overall health and quality of life for women struggling with infertility,” concludes Mohammad.

https://www.clinicaltrialsarena.com/analyst-comment/2024-kicks-off-with-a-surge-in-clinical-trials-tackling-womens-infertility/