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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01856361 |
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Date of registration:
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09/05/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Ramipril for the Treatment of Oligospermia
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Scientific title:
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Ramipril for the Treatment of Oligospermia: A Double-Blind Randomized Control Trial |
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Date of first enrolment:
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July 2013 |
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Target sample size:
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2 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01856361 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Peter N Schlegel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Male Infertility
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Teratospermia
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Asthenozoospermia
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Oligospermia
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Intervention(s)
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Drug: Ramipril
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Drug: Placebo
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Primary Outcome(s)
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Sperm Density in Infertile Men With Documented Oligospermia.
[Time Frame: 32 weeks]
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Secondary Outcome(s)
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Total Motile Sperm Count(TMSC), Total Sperm Count, Sperm Motility, and Morphology in the Ejaculate.
[Time Frame: 32 weeks]
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Hormonal Profile
[Time Frame: 32 weeks]
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Pregnancy Rate
[Time Frame: 32 weeks]
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Secondary ID(s)
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1301013462
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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