6 Clinical Trials for Various Conditions
The ability of sperm to swim is important for normal fertility. Men with a genetic variation in the gene coding for Choline Dehydrogenase (CHDH) have decreased energy production by sperm, and their sperm do not swim normally. The metabolic product of this gene is a nutrient called betaine (found normally in the diet as a part of many foods such as spinach, beets and grain products). This study tests whether treatment with betaine is safe and whether it can normalize energy production in sperm of these men and restore normal swimming ability.
Objectives: Male factor infertility is poorly understood and our ability to evaluate the male contribution to a couple's infertility is very limited. The overarching goal of this project is to understand at the molecular level what functional activities in human sperm are required for successful fertilization leading to full term development. These findings will allow us to develop new methods to determine the impact of environmental exposures on sperm quality and male fertility. A sperm protein known as phospholipase C zeta (PLC zeta) initiates embryo development at fertilization. The primary objective of this study is to test the hypothesis that human PLC zeta activity correlates directly with the proportion of fertilized eggs that undergo early cleavage during an in vitro fertilization (IVF) cycle. Secondary objectives for the study are to generate preliminary data regarding the variability in sperm PLC zeta activity within and between individuals and to determine if there are clinical or laboratory correlates for sperm PLC zeta activity. Study population: The study population will consist of 178 infertile couples undergoing IVF procedures at Duke Fertility Center (DFC) from which we will obtain 154 evaluable couples for the study. Overall Design: An observational cohort study design will be used to assess the association of PLC zeta activity in the residual sperm from the sample used for an IVF cycle with the proportion of eggs per couple that undergo early cleavage during the same cycle. Infertile couples enrolling in an IVF treatment cycle at DFC will be approached for inclusion in the study. Consent will be obtained from both male and female partners, and historical medical information and information about their IVF cycle will be collected by chart review. Blood for isolation of serum and DNA will be collected only from the male partner for evaluation of hormone levels and genetic analyses related to infertility. On the day of the egg retrieval, residual sperm not needed for clinical purposes will be transported via courier to NIEHS. Sperm PLC zeta activity will be measured in the investigator's laboratory using an experimental bioassay. Sperm PLC zeta protein will be analyzed at the University of Massachusetts. Outcome Parameters: The primary outcome will be the proportion of embryos that undergo early cleavage. Secondary outcomes will include proportion of eggs fertilized, embryo development parameters, and p...
Assess the effect of daily treatment of vardenafil 20mg or sildenafil 100mg and placebo on sperm function
The purposes of this study are to: * Determine the effect of the study drug on sperm and semen of healthy young male subjects. * Determine the effect of age on the amount of study drug in the blood of healthy subjects * Learn about the safety of the study drug. * Learn how subjects tolerate the study drug.
This study compares the effects of omega 3 fats plus folic acid with placebo plus folic acid on sperm quality and sexual function in infertile men. It will also evaluate the effects on sexual fuction of a sub-therapeutic dose of a PDE 5 inhibitor versus placebo in subjects continuing on both omega 3 fats and folic acid.
The purpose of this study is to understand the direct effects of cannabis on male reproductive functions. The investigators plan to conduct a double-blind, placebo-controlled clinical trial to examine both the chronic and acute effects of cannabis use on male reproductive functions. Specifically, the investigators will examine the dose-dependent effects of acute cannabis use on male reproductive parameters, including sperm counts, motility, morphology, and testosterone levels, as well as sperm epimutations. Participants \[cannabis users will be randomly assigned to 1) non-vaping, 2) placebo (vaping without cannabis), and 2 doses of cannabis, 3) 20 and 4) 40mg of THC in cannabis flower obtained from the NIDA drug supply\], and 5) non-cannabis users (naïve control, no cannabis or placebo exposure). Participants will provide surveys (cannabis use and sexual functioning and satisfaction etc.), peripheral blood, and semen.