A methyl group is a single carbon atom bonded with three hydrogen atoms. The methionine pathway of One Carbon Metabolism (OCM) produces S-adenosylmethionine (SAMe), the universal activated methyl donor in the human body. Methyl groups can be dynamically transferred to and from biological macromolecules such as DNA, RNA and proteins in a process called methylation to influence structure and function. What is homocysteine (HCY)? We aimed to recruit 1200 male participants as a part of an infertile couple, based on the following data and power calculation.

I wanted to post this because I felt devastated after the first analysis. Every single one of my husband’s parameters, including count, has improved drastically in % terms. For anyone who doesn’t know the tablets are usually given to people who are going on holiday but don’t want a period so the tablet delays the period but after stopping them you have a ‘withdrawal bleed’. SUSARs that have arisen in other clinical trials of the same sponsor and with the same medicinal product, and that could have consequences for the safety of the subjects involved in the clinical trial that was assessed by the METC. At least two semen analyses will be performed at two time points in this study: the first semen analysis will be performed during diagnostic workup (standard care and analysis according to WHO criteria 37) and the second one after approximately 3 months of using study medication for participants having the IUI or IVF/ICSI treatment. We decided not to perform a second semen analysis in the EM group due to the fact that they present with normal semen parameters at intake, and we want to avoid the burden of an extra visit.Any other important medical event that did not result in any of the outcomes listed previously due to medical or surgical intervention but could have been based on appropriate judgement by the investigator. The study is designed as a superiority trial. Based on the above mentioned data, we expect a 7.3% increase in ongoing pregnancy number when men are treated with Impryl compared with placebo. However, after randomisation, patients can directly start with both intervention and achieving a pregnancy, either spontaneously or with fertility treatment. In these first months, the effect of the intervention is expected to be suboptimal due to the duration of the spermatogenesis (72 days before whole renewal). Therefore, we adjusted the expected increase of 7.3% to a more realistic effect of 6.5%. We assume an equal increase in all fertility groups (meaning EM, IUI and IVF/ICSI) from 20% to 26.5%. Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as 'idiopathic', except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%-87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate. Impryl is a dietary integration and just like any other meal, the benefits immediately starts at assumption and stop at withdrawal with a minimal remnant effect. However, the longer the treatment, the larger the benefits. OCM is important because it functionally connects the dietary intake of micronutrients with critical biological processes, including homocysteine recycling, DNA/RNA synthesis, cellular energy production, natural antioxidant activity and gene expression. Learn about how Impryl works. Disruption of OCM by diet, environmental exposure or genetic variations is associated with multiple human reproductive health problems, including reduced sperm health and egg quality, infertility and miscarriage, as well as birth defects, including spina bifida. What is a methyl group?

Funding The study is supported by an unrestricted grant from Goodlife Pharma BV. This company has developed and marketed Impryl. The grant is unrestricted in means that the funder did not have any role in the design of the study, collection, analysis and/or interpretation of data. The investigators have full access to the data and have the right to publish these data separate and apart from any sponsor. The adverse reaction must be unexpected, that is to say, the nature and severity of the adverse reaction are not in agreement with the product information as recorded in In addition, a per-protocol analysis will be performed for the primary outcome and the secondary outcomes overall pregnancy number, time to pregnancy, number of miscarriages and live birth rate. Fertility Family is part of Health Medica, a UK healthcare company. Our range of high quality products is recommended by fertility specialists across the UK. Read more about us. I had been diagnosed with asthenozoospermia (not enough motility) and my volume was consistently lower than average.

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In April 2023, he had a semen analysis which showed only 19% progressive, and these were “sluggish progression.” He had ZERO in “excellent progression.”

The protocol and all protocol modifications are approved by the local METC at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects with protocol ID NL61414.091.17. At the appointment we were given a leaflet and recommendation to take Impryl which initially we dismissed as just another tablet to take. However, after taking for 1 MONTH (honestly true!) my wife and I are pregnant and awaiting our 12 week scan in a few weeks. Contributors Study concept and design were conducted by authors RS and KF. Advanced statistical input was given by author JIH. Critical revision of concept and design and intellectual input in the study protocol were done by authors RS, KF, KD'H, JIH and DB. Study supervision and coordination were conducted by authors RS and KF. The consultant recommended to my husband that he take Impryl and we keep trying. He was a bit dubious but thought, why not. I’m 28 and my partner is 30 this year. We changed nothing in our routine accept changing our vitmains to Impryl and inofolic alpha.Impryl is a nutritional supplement mainly consisting of vitamin B, which works on the metabolic system by activating the 1-carbon cycle and recycling of homocysteine without the use of any direct strong antioxidant. Therefore, it could be more effective than other nutritional supplements. The cost of Impryl is €30 for each 30 days of use. Yes, Impryl can be used by individuals who consciously choose to avoid products of animal origin. In addition, none of the ingredients in Impryl are produced using genetically modified organisms (GMO). Does IMPRYL® contain any artificial colors or flavors?

Infertility can be a lonely, all-consuming place to be. It can affect every aspect of your life. You may have been trying to get pregnant for a while, you may need help trying to conceive, you may be going through fertility treatment and want to optimise your fertility or you may have only just decided that you want to get pregnant. Whatever the case, we want to reassure you that you aren’t alone — we provide information and products to support your fertility. Inofolic ® Alpha and Impryl ® are fertility supplements that focus on helping both the sperm and the egg to be of optimal quality to help you enjoy a healthy pregnancy. This study is registered in the American registry for clinical studies and trials ( https://clinicaltrials.gov) and the Dutch Trial registry ( www.trialregister.nl). The investigator obtains written informed consent before study participation from all participants.

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We will analyse all data on an intention-to-treat basis. Data of patients who are lost to follow-up will be included in their randomised group: MTHF and methylcobalamin are methyl donors necessary for the re-methylation of homocysteine to methionine. Carriers of defective genetic variants of methylenetetrahydrofolate reductase (MTHFR) and methionine synthase reductase (MTRR), are weak producers of, respectively, 5-MTHF and methylcobalamin and may be at risk of shortage of these substances. What is the importance of Betaine? Overall number of pregnancies, meaning the cumulative pregnancy number up to 9 months after start of intervention. However, it may happen that multiple genetic variants on the same pathway converge on the same subject generating a critical assembly. In these cases any increased demand or toxic load may generate a metabolic collapse. Such collapse is predicted to occur at time of increased demand, which in the case of the one carbon metabolism is at time to reproduce. How is IMPRYL® manufactured?