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
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Condition or disease | Intervention/treatment | Phase |
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Oligospermia Teratospermia Asthenozoospermia Male Infertility | Drug: Ramipril Drug: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ramipril for the Treatment of Oligospermia: A Double-Blind Randomized Control Trial |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | June 2016 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
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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.
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Drug: Ramipril
Angiotensin Converting Enzyme Inhibitor
Other Name: Altace |
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.
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Drug: Placebo
Placebo pill that will match the treatment pill
Other Name: Sugar pill |
- Sperm Density in Infertile Men With Documented Oligospermia. [ Time Frame: 32 weeks ]
- 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
- Seminal Angiotensin II and Serum Bradykinin Levels [ Time Frame: 32 weeks ]

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male partner of a couple presenting for infertility.
- 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.
- Age 18-45 years.
- Normal renal function defined as Glomerular filtration rate > 90
Exclusion Criteria:
- Patients that are currently taking thiazide, cyclosporin, lithium, and allopurinol or the use of these medications in the last 2 weeks.
- The frequent use of NSAIDS (3 or more times a week).
- Vasectomy reversal.
- Regular use of tobacco products.
- Mean white blood cell count >1 million/ml in the ejaculate.
- Inability or unwillingness to participate in evaluations required by the study.
- Potassium > 5.0.
- Systolic blood pressure < 90 mmHg.
- Currently use of ACEI

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856361
United States, New York | |
Weill Cornell Medical College, Department of Urology | |
New York, New York, United States, 10065 |
Principal Investigator: | Peter N Schlegel, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT01856361 |
Other Study ID Numbers: |
1301013462 |
First Posted: | May 17, 2013 Key Record Dates |
Results First Posted: | June 2, 2017 |
Last Update Posted: | June 2, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Male infertility Low sperm count Poor sperm motility Poor Sperm shape and morphology |
Infertility Infertility, Male Oligospermia Asthenozoospermia Teratozoospermia Ramipril |
Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |