NCT01856361

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 2, 2017

Completed
Last Updated

June 2, 2017

Status Verified

April 1, 2017

Enrollment Period

2.9 years

First QC Date

May 9, 2013

Results QC Date

January 13, 2017

Last Update Submit

April 27, 2017

Conditions

OligospermiaTeratospermiaAsthenozoospermiaMale Infertility

Keywords

Male infertilityLow sperm countPoor sperm motilityPoor Sperm shape and morphology

Outcome Measures

Primary Outcomes (1)

  • Sperm Density in Infertile Men With Documented Oligospermia.

    32 weeks

Secondary Outcomes (3)

  • Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.

    32 weeks

  • Pregnancy Rate

    32 weeks

  • Hormonal Profile

    32 weeks

Other Outcomes (1)

  • Seminal Angiotensin II and Serum Bradykinin Levels

    32 weeks

Study Arms (2)

Ramipril

EXPERIMENTAL

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

Placebo

SHAM COMPARATOR

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

Interventions

RamiprilDRUG

Angiotensin Converting Enzyme Inhibitor

Also known as: Altace
Ramipril
PlaceboDRUG

Placebo pill that will match the treatment pill

Also known as: Sugar pill
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College, Department of Urology

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

OligospermiaTeratozoospermiaAsthenozoospermiaInfertility, Male

Interventions

RamiprilSugars

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Peter N Schlegel, MD
Organization
Weill Cornell Medical College
pnschleg@med.cornell.edu
2127465491

Study Officials

  • Peter N Schlegel, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 17, 2013

Study Start

July 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 2, 2017

Results First Posted

June 2, 2017

Record last verified: 2017-04

Locations

US(1)