Ramipril for the Treatment of Oligospermia - Full Text View

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 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

Resource links provided by NLM:

Genetics Home Reference related topics: CATSPER1-related nonsyndromic male infertility Y chromosome infertility sensorineural deafness and male infertility

MedlinePlus related topics: Infertility

Drug Information available for: Ramipril

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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

Other Outcome Measures:

Seminal Angiotensin II and Serum Bradykinin Levels [ Time Frame: 32 weeks ]


Enrollment:	2
Study Start Date:	July 2013
Study Completion Date:	June 2016
Primary Completion Date:	June 2016 (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 (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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 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

Locations


United States, New York
Weill Cornell Medical College, Department of Urology
New York, New York, United States, 10065

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:

Department of Urology Cornell This link exits the ClinicalTrials.gov site


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
Results First Received:	January 13, 2017
Last Updated:	April 27, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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 Infertility, Male Oligospermia Asthenozoospermia Genital Diseases, Male Genital Diseases, Female	Ramipril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents

ClinicalTrials.gov processed this record on August 18, 2017