FITMI is an abbreviation for First in Treating Male Infertility and is a research project carried out on Rigshospitalet’s department for Growth and Reproduction.
The purpose of FITMI is to investigate whether it is possible to improve the sperm production of men with lowered sperm count, and thereby improve the fertility of men with lowered sperm count. Over time that would make it possible to treat men in fertility treatment - and not just women.
Concretely the men in the study will be treated with Prolia (Denosumab). Prolia is a drug for osteoporosis and is also given to men in anti-hormo treatment.
The study is approved by all appropriate authorities.
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Participants must be over the age of 18 years old and have a lowered sperm count with a sperm concentration between D1-20 million per mL.
Besides this requirement participants cannot suffer from any other significant diseases.
On the day of the screening the reproductive hormone AMH will be measured and must be above 38 pmol/L.
You get the chance to be treated for lowered sperm count and to be part of ensuring better treatment for men with lowered sperm count in the future.
The participation in the project is voluntary and you can step out of the study at any time.
You will have to meet up at the hospital 3 times and deliver a sperm sample, blood sample and to take the medication.
The researchers behind FITMI have found the indication of a special protein called RANKL in the testicles of men. That indicated that this protein has a direct effect on the production of sperm cells. That is interesting as there is a drug (Denosumab), which can block RANKL.The first step in the research was to inhibit RANKL in various animal and human models. Here it was shown that Denosumab increased the amount of sperm creating cells. That indicated that the drug could potentially stimulate sperm cell production. As we know from other patient groups that Denosumab is safe and effective, we will through FITMI investigate whether treatment with Denosumab can increase the total number of men’s motile sperm cells and in that way increase sperm quality.