Clinical Trial: Ramipril for the Treatment of Oligospermia

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Ramipril for the Treatment of Oligospermia: A Double-Blind Randomized Control Trial

Brief Summary: 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.

Detailed Summary: Approximately half of all infertility problems are caused by male factors. These men account for 17% of patients at the primary health care level that seek help for infertility. Oligospermia (Low sperm count) of unknown cause occurs in up to 60% of men with unexplained infertility. Certain group of patients with oligospermia can father children, but those with infertility have long posed a major therapeutic challenge. A variety of empirical non-specific treatments have been used, in attempt to improve their semen characteristics and fertility. In the past, androgens were suggested as a treatment; however, exogenous testosterone was found to exert negative feedback on the pituitary-gonadal axis and thereby suppresses Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) secretion then adversely affects sperm production. Other treatment modalities like clomiphene citrate, tamoxifen, recombinant FSH, zinc, selenium, and L-carnitine have been tried with minimal success. In the present study we are proposing the use of an angiotensin converting enzyme inhibitor (ACEI) for the treatment of oligospermia. A recently published pilot study showed that the use of lisinopril improved sperm quantity and quality in oligospermic men. ACEI are inexpensive, safe, widely available, and, if effective in improving sperm production and quality, could avert couples from undergoing invasive procedures.
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: Sperm density in infertile men with documented oligospermia. [ Time Frame: 32 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total Motile Sperm Count(TMSC), total sperm count, sperm motility, and morphology in the ejaculate. [ Time Frame: 32 weeks ]
    The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.
  • Pregnancy rate [ Time Frame: 32 weeks ]
  • Hormonal profile [ Time Frame: 32 weeks ]
    LH, FSH, serum testosterone, prolactin


Original Secondary Outcome: Same as current

Information By: Weill Medical College of Cornell University

Dates:
Date Received: May 9, 2013
Date Started: July 2013
Date Completion: June 2014
Last Updated: September 5, 2013
Last Verified: September 2013