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Ramipril for the Treatment of Oligospermia

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ClinicalTrials.gov Identifier: NCT01856361
Recruitment Status : Terminated (We did not accrue as much as anticipated and the PI (Dabaja) is no longer at Weill Cornell.)
First Posted : May 17, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 17, 2013
Results First Submitted Date  ICMJE January 13, 2017
Results First Posted Date  ICMJE June 2, 2017
Last Update Posted Date June 2, 2017
Study Start Date  ICMJE July 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Sperm Density in Infertile Men With Documented Oligospermia. [ Time Frame: 32 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01856361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 16, 2013)
Seminal Angiotensin II and Serum Bradykinin Levels [ Time Frame: 32 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Ramipril for the Treatment of Oligospermia
Official Title  ICMJE 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 Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Oligospermia
  • Teratospermia
  • Asthenozoospermia
  • Male Infertility
Intervention  ICMJE
  • Drug: Ramipril
    Angiotensin Converting Enzyme Inhibitor
    Other Name: Altace
  • Drug: Placebo
    Placebo pill that will match the treatment pill
    Other Name: Sugar pill
Study Arms  ICMJE
  • Experimental: Ramipril
    The 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.
    Intervention: Drug: Ramipril
  • Sham Comparator: Placebo
    The 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 27, 2017)
2
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
60
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01856361
Other Study ID Numbers  ICMJE 1301013462
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter N Schlegel, MD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP