Oligospermia | Ramipril for the Treatment of Oligospermia
Oligospermia research study
What is the primary objective of this study?
This is a randomized controlled trial to evaluate the effect of ramipril in stimulating and promoting sperm production in men with low sperm count. Ramipril is an Angiotensin Converting Enzyme Inhibitor (ACEI) currently used to treat high blood pressure. However, previous studies have shown that this class of medications can improve sperm parameters. The purpose of this study is to evaluate the efficacy of ramipril compared to placebo (Substance That is not known to have treatment effect), in improving sperm density in infertile men with documented low sperm count. This study will help us identify subjects that might benefit from treatment with this medication, and the effect it will have on sperm count, shape, and motility.
Who is eligible to participate?
Inclusion Criteria: 1. Male partner of a couple presenting for infertility. 2. Moderate abnormalities of semen parameters (Mean sperm density <20 million, but ≥ 3 million/ml), and/or motility < 50%, and/or < 4% abnormal morphology on at least two separate occasions. 3. Age 18-45 years. 4. Normal renal function defined as Glomerular filtration rate > 90 Exclusion Criteria: 1. Patients that are currently taking thiazide, cyclosporin, lithium, and allopurinol or the use of these medications in the last 2 weeks. 2. The frequent use of NSAIDS (3 or more times a week). 3. Vasectomy reversal. 4. Regular use of tobacco products. 5. Mean white blood cell count >1 million/ml in the ejaculate. 6. Inability or unwillingness to participate in evaluations required by the study. 7. Potassium > 5.0. 8. Systolic blood pressure < 90 mmHg. 9. Currently use of ACEI
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RamiprilAngiotensin Converting Enzyme Inhibitor
Drug:PlaceboPlacebo pill that will match the treatment pill
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
RamiprilThe initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.
PlaceboThe placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.
Start Date: July 2013
Completed Date: June 2016
Primary Outcome: Sperm Density in Infertile Men With Documented Oligospermia.
Secondary Outcome: Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.
Study sponsors, principal investigator, and references
Principal Investigator: Peter N Schlegel, MD
Lead Sponsor: Weill Medical College of Cornell University