Ramipril for the Treatment of Oligospermia

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01856361
• Other study ID #: 1301013462
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2013
• Last updated: September 5, 2013
• Start date: July 2013
• Est. completion date: June 2014

Study information

• Verified date: September 2013
• Source: Weill Medical College of Cornell University
• Contact: Ali A Dabaja, MD
• Phone: 212 746 5470
• Email: aad9008[@]med.cornell.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthenozoospermia
• Infertility
• Infertility, Male
• Male Infertility
• Oligospermia
• Teratospermia

Intervention

Drug:
• Ramipril
Angiotensin Converting Enzyme Inhibitor
• Placebo
Placebo pill that will match the treatment pill

Locations

Country	Name	City	State
United States	Weill Cornell Medical College, Department of Urology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Seminal Angiotensin II and serum bradykinin levels		32 weeks	No
Primary	Sperm density in infertile men with documented oligospermia.		32 weeks	No
Secondary	Total Motile Sperm Count(TMSC), total sperm count, sperm motility, and morphology in the ejaculate.	The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.	32 weeks	No
Secondary	Pregnancy rate		32 weeks	No
Secondary	Hormonal profile	LH, FSH, serum testosterone, prolactin	32 weeks	No

External Links

•   Department of Urology Cornell