Ramipril for the Treatment of Oligospermia

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01856361
First received: May 9, 2013
Last updated: September 5, 2013
Last verified: September 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Sperm density in infertile men with documented oligospermia. [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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
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.
Drug: Placebo
Placebo pill that will match the treatment pill
Other Name: Sugar pill

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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856361

Contacts
Contact: Ali A Dabaja, MD 212 746 5470 aad9008@med.cornell.edu

Locations
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   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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:
Male infertility
Low sperm count
Poor sperm motility
Poor Sperm shape and morphology

Additional relevant MeSH terms:
Infertility, Male
Infertility
Oligospermia
Asthenozoospermia
Genital Diseases, Male
Genital Diseases, Female
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014