In a nutshell
This review looked at how often artificial gonadotropin hormones such as human follitropin alpha (Gonal-F) caused ovarian hyperstimulation syndrome (OHSS) or blood clots. It found that these conditions are infrequent side effects of using gonadotropins to stimulate the ovaries.
In a natural menstrual cycle, follicle-stimulating hormone (FSH) causes the ovarian follicles to develop. During ovulation, an oocyte (egg) is released from the follicle. FSH is part of a group of hormones known as gonadotropins.
Gonadotropins are used during infertility treatment including in vitro fertilization (IVF). These hormones can be purified from the urine of menopausal women (Menopur). However, genetic engineering technology also allows for the production of gonadotropins. Recombinant FSH (r-FSH; Gonal-F) is a type of gonadotropin produced using hamster cells which is identical to human FSH.
High doses of gonadotropins are used during infertility treatment compared to a natural menstrual cycle, and this can have side effects. The ovaries sometimes respond too strongly to these medications, leading to swelling and discomfort. This condition is known as ovarian hyperstimulation syndrome (OHSS), and it can have serious complications. It is important to examine how often OHSS occurs when using r-FSH.
Methods & findings
This review included 45 studies of 5186 patients receiving r-FSH. The review also examined side effects reported to a German public health agency.
5.19% of r-FSH treatment cycles resulted in OHSS. Most of the studies (73.3%) classified whether the OHSS was severe. There were 10 reported cases of severe OHSS, which was 3.7% of all OHSS cases. There were no cases of blood clots in the studies.
The health agency received reports of 1110 cases of OHSS. This represents approximately 0.007% of r-FSH treatment cycles conducted in Germany during that time. The health agency also received 80 reports of blood clots.
The bottom line
This review found that blood clots and severe OHSS are unusual side effects of r-FSH.
The fine print
Most side effects in clinical practice are never reported to health agencies. However, these reports are useful to identify rare side effects which may not occur during clinical trials, such as blood clots.
Published By :
Advances in therapy
Oct 15, 2020