Ramipril for the Treatment of Oligospermia
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Women's Studies, Infertility |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 4/2/2016 |
| Start Date: | July 2013 |
| End Date: | June 2014 |
| Contact: | Ali A Dabaja, MD |
| Email: | aad9008@med.cornell.edu |
| Phone: | 212 746 5470 |
Ramipril for the Treatment of Oligospermia: A Double-Blind Randomized Control Trial
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.
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.
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.
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
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