Ramipril for the Treatment of Oligospermia

NCT ID: NCT01856361

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

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.

Conditions

Oligospermia; Teratospermia; Asthenozoospermia; Male Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ramipril

Intervention Type: DRUG

Angiotensin Converting Enzyme Inhibitor

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.

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo pill that will match the treatment pill

Interventions

Ramipril

Angiotensin Converting Enzyme Inhibitor

Intervention Type: DRUG

Placebo

Placebo pill that will match the treatment pill

Intervention Type: DRUG

Other Intervention Names

Altace; Sugar pill

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter N Schlegel, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medical College, Department of Urology

New York, New York, United States

Countries

United States

Related Links

https://www.cornellurology.com

Department of Urology Cornell

Other Identifiers

1301013462

Identifier Type: -

Identifier Source: org_study_id