An interventional study of Ramipril and Placebo in Oligospermia, Teratospermia and Asthenozoospermia, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
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.
64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.
This study's enrollment of 2 is below the median of 65 across 46 interventional studies indexed under Oligospermia.
Browse Oligospermia studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Angiotensin Converting Enzyme Inhibitor
Also known as: Altace
Placebo pill that will match the treatment pill
Also known as: Sugar pill
Sperm Density in Infertile Men With Documented Oligospermia.
Time frame: 32 weeks
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.
Time frame: 32 weeks
Pregnancy Rate
Time frame: 32 weeks
Hormonal Profile
LH, FSH, serum testosterone, prolactin
Time frame: 32 weeks
Seminal Angiotensin II and Serum Bradykinin Levels
Time frame: 32 weeks
| Milestone | Ramipril | Placebo |
|---|---|---|
| Started | 1 | 1 |
| Completed | 1 | 1 |
| Not completed | 0 | 0 |
No measurements were reported for this outcome.
The efficacy of ramipril in improving total sperm count will be evaluated, as well as, improving sperm motility, and morphology.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
LH, FSH, serum testosterone, prolactin
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ramipril | — | 0/1 (0%) | 0/1 (0%) |
| Placebo | — | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Ramipril | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Ramipril | Placebo | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 1 | 1 | 2 |
Plan to share: Undecided
The record gives a start of Jul 2013, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2017, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ramipril
Weill Medical College of Cornell University →