Twice weekly injections of the hormone kisspeptin may provide a new treatment to restore fertility in some women. The research is being presented at the Society for Endocrinology BES meeting in Manchester. The findings show that twice-weekly injections of kisspeptin can lead to increases in the levels of sex hormones, which control the menstrual cycle. This is the first study to show this effect can be maintained over the long term and it may lead to new therapies for women whose infertility is due to low sex hormone levels.
Kisspeptin is a product of the KISS-1 gene and is a key regulator of reproductive function. Animals and humans lacking kisspeptin function do not go through puberty and remain sexually immature. A team led by Dr Waljit Dhillo of Imperial College London studied women with a condition called hypothalamic amenorrhoea, where a deficiency in sex hormone levels prevents menstruation, resulting in infertility. This affects several thousand women in the UK each year. Previously, Dr Dhillo's group found that a one-off injection of kisspeptin caused an increase in sex hormone production in these women, but further daily administration was not effective as the system stopped responding. The aim of the present study was to examine kisspeptin's potential as a fertility treatment by finding a dose regimen that would maintain sex hormone production over a sustained period of time.
Over eight weeks, a group of 10 women with hypothalamic amenorrhoea were either given twice-weekly injections of kisspeptin (n=5) or twice-weekly injections of saline as a control (n=5). Blood samples were then taken at regular intervals to measure their levels of luteinising hormone (LH) and follicle stimulating hormone (FSH), two sex hormones essential for ovulation and fertility. Women demonstrated a large increase in circulating sex hormones on day 0 (mean maximal LH increase 21.5IU/l), which was halved to 10.0IU/l on day 14. However, after day 14, their responsiveness to the kisspeptin treatment remained steady. On the last day of the trial, women who had been given kisspeptin injections showed a 16-fold increase in their hormonal response, compared to the saline controls.
This is the first long term clinical study to examine the effectiveness of kisspeptin treatment. Twice-weekly injections of kisspeptin, administered over a two month period, can successfully stimulate the release of sex hormones in women with infertility due to hypothalamic amenorrhoea and this treatment does not cause any side-effects. These findings now need to be confirmed in large-scale randomised trials, before any treatments can be brought into clinical practice.
Researcher Dr Waljit Dhillo said:
"Infertility is a highly distressing condition and affects up to one in seven couples in the UK. The results of our study are exciting as they show that kisspeptin may be a novel method for restoring fertility to women with certain types of infertility. Our findings show that an injection of kisspeptin given twice-weekly can reinvigorate the reproductive hormone system in women and raise their levels of luteinising hormone and follicle stimulating hormone, both of which are essential for fertility.
"It is important to emphasise that this is only a small study and we need to carry out further work before our findings can be brought into clinical practice. Our next step is to perform a much bigger clinical study with a larger number of participants to see if kisspeptin administration can enable women with hypothalamic amenorrhoea to regain fertility."
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