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New Drug Found to Improve Fertility in Women with Reproductive Health Issues
Details about a new drug therapy that has shown promise in treating women with reproductive health issues.
June 4, 2021
A new drug therapy has been found and studied to show promising results in treating women with reproductive health issues. The therapy involved injection of a drug called MVT-602 which targets the kisspeptin system to stimulate reproductive hormones that have effects on fertility, sexual development, and menstruation. Kisspeptin is a naturally occurring hormone in the hypothalamus that encourages reproductive health.
What is Kisspeptin?
Kisspeptin is a naturally occurring hormone that impacts the levels of other reproductive hormones in the body and also plays a crucial role in fertility, reproductive health and the regulation of a woman’s menstrual cycle. Studies from the past have shown that kisspeptin can be used to safely encourage the proper function of reproductive hormones in women undergoing IVF treatment without causing OHSS. The research team on this study wanted to see whether MVT-602 could stimulate the kisspeptin pathway and encourage a longer hormonal release than that from the naturally occurring form of kisspeptin.
Two dozen women were injected with a drug called MVT-602 designed to target their kisspeptin system. The naturally occurring form of kisspeptin called kisspeptin-54 (KP54) has been being researched for a long time to treat reproductive disorders, but in this new study, MVT-602 was able to provoke a more potent stimulation of the kisspeptin system over a longer period of time than KP54.
The researchers behind the study believe that MVT-602 could be used in treatment of a wide range of reproductive issues that affect fertility in women. Some examples of those conditions include polycystic ovary syndrome (PCOS), which is a very common condition that affects the function of a woman's ovaries, and hypothalamic amenorrhea (HA) which is a condition where a woman's periods stop for seemingly no reason.
The researchers hypothesize that because of MVT-602's extended duration of action, it can be injected less frequently than the naturally occurring form of kisspeptin, while still being able to maintain the degree of action in reproductive hormone levels that are required to restore or better reproductive health.
The study was published in the Journal of Clinical Investigation, and was led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust.
Professor Waljit Dhillo, lead author on the study, NIHR Research Professor in Endocrinology and Metabolism at Imperial College London and Consultant in Endocrinology at Imperial College Healthcare NHS Trust said:
"Reproductive health issues are common for women around the world. Infertility as a result of these conditions can cause a lot of distress. Although we have made great strides in developing treatments for infertility and other reproductive disorders there is a need to find more effective treatments. Our previous work showed that kisspeptin can be used to stimulate ovulation in women undergoing in vitro fertilisation (IVF) treatment, but there are some limitations on using the naturally occurring kisspeptin hormone as its effectiveness wears off after a few hours. This study suggests that MVT-602 can stimulate kisspeptin over a longer period of time with no side effects, which means we could potentially use it to treat a wider range of reproductive disorders. This is an early stage study and more research needs to be carried out to fully determine the effects of MVT-602 on more patients."
Dr Ali Abbara, NIHR Clinician Scientist at Imperial College London and Consultant in Endocrinology at Imperial College Healthcare NHS Trust, who co-led the study said: "This is the first study to show that a single dose of MVT-602 can induce a longer duration of hormonal stimulation in women than naturally occurring kisspeptin. Therefore, it reveals exciting potential to treat a range of reproductive health conditions using MVT-602 and offer women improved treatment options. However, further research is needed to fully characterise its effects in specific disorders that affect reproductive health."
Studies show that one in ten women in the United Kingdom are diagnosed with PCOS or HA. The current treatments for these conditions can include making dietary changes, administering medicines that treat infertility by restoring ovulation, and IVF treatment for those who are still unable to conceive after other interventions. It is important to note, however, that women with PCOS who undergo IVF treatment are at a higher risk of 'ovarian hyperstimulation syndrome' (OHSS) which is a potentially life-threatening side-effect of IVF treatment.
The researchers performed the study and trial at Hammersmith Hospital, which is part of Imperial College Healthcare NHS Trust. The trial was carried out on 24 women aged between the ages of 18 and 35 between 2017 and 2019. Twelve of the women involved were healthy, reproductively normal volunteers and the other 12 had either PCOS or HA. All of the women were injected with the same MVT-602.
Additionally for all the healthy volunteers, they were injected with the naturally occurring kisspeptin and a saline placebo for the sake of comparison. From this, the researchers compared the women's reproductive hormone levels after receiving MVT-602 to the naturally occurring kisspeptin. They additionally compared the reproductive hormone levels after MVT-602 between healthy women, women with HA and women with PCOS.
The researchers found that all of the women given MVT-602 had an extended duration of highered reproductive hormones, specifically the luteinising hormone and follicle stimulating hormone. This was compared to the results of the women who received naturally occurring kisspeptin. Luteinising hormone levels were at their highest at 21-22 hours after MVT-602 and remained raised for 48 hours. With the natural kisspeptin, the luteinising hormone levels were at their highest at 4.7 hours and remained raised for 12-14 hours.
Clearly, the duration of luteinising hormone elevation was much higher using MVT-602. Luteinising hormone increases after the MVT-602 injection were similar in women with PCOS and healthy women, but elevated faster in women with HA. Researchers believe that this could be because women with HA have more kisspeptin receptors in the hypothalamus of the brain where kisspeptin acts as a direct consequence of their condition.
The researchers will now take their findings and hope to carry out subsequent studies using MVT-602 in women with reproductive disorders. The study was funded by NIHR Imperial Biomedical Research Centre (BRC) and an NIHR Professorship & Clinician Scientist Awards.
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