Ramipril for the Treatment of Oligospermia
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Purpose
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.
| Condition | Intervention |
|---|---|
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Oligospermia Teratospermia Asthenozoospermia Male Infertility |
Drug: Ramipril Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Ramipril for the Treatment of Oligospermia: A Double-Blind Randomized Control Trial |
- Sperm density in infertile men with documented oligospermia. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
- Total Motile Sperm Count(TMSC), total sperm count, sperm motility, and morphology in the ejaculate. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Hormonal profile [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]LH, FSH, serum testosterone, prolactin
- Seminal Angiotensin II and serum bradykinin levels [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Drug: Ramipril
Angiotensin Converting Enzyme Inhibitor
Other Name: Altace
|
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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
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01856361
| Contact: Ali A Dabaja, MD | 212 746 5470 | aad9008@med.cornell.edu |
| United States, New York | |
| Weill Cornell Medical College, Department of Urology | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Ali A Dabaja, MD 212-476-5470 aad9008@med.cornell.edu | |
| Contact: Jim B Estil 6469628300 Jie2001@med.cornell.edu | |
| Principal Investigator: | Peter N Schlegel, MD | Weill Medical College of Cornell University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT01856361 History of Changes |
| Other Study ID Numbers: | 1301013462 |
| Study First Received: | May 9, 2013 |
| Last Updated: | September 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Weill Medical College of Cornell University:
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Male infertility Low sperm count Poor sperm motility Poor Sperm shape and morphology |
Additional relevant MeSH terms:
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Infertility, Male Asthenozoospermia Infertility Oligospermia Genital Diseases, Female Genital Diseases, Male Ramipril Angiotensin-Converting Enzyme Inhibitors |
Antihypertensive Agents Cardiovascular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015