The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
This study was conceived in order to explain what the investigators previously observed
suggesting that lisinopril, a drug normally used to treat patients with high blood pressure
and heart failure, may be effective in treating infertile men with low sperm count. The
investigators hypothesized, therefore, that the drug will not only improve sperm quantity and
quality but also increase the fertility in such patients. The investigators first of all
reviewed the results of previously published investigations and found out that there was only
a few previous studies done in humans.with this class of drugs. Besides, the methods used in
conducting most of those studies have been so faulted that the results cannot be trusted to
be showing the true picture. The investigators looked at the various faults pointed out with
respect to the their design and conduct and took care of them while designing the
investigators own study. This was an attempt to provide more credible answers to the question
of whether lisinopril, and possibly other drugs of similar mode of action, can be useful in
rectifying the problem of infertility caused by low sperm count and , if so, whether it will
be safe to use it in people who do not have high blood pressure or heart failure. In order to
achieve this the investigators studied 33 patients with sperm of low cell concentration, low
percentage of motile cells and high percentage of abnormal cells from no known cause. The
patients were randomly allocated to receive either lisinopril 2.5mg daily (17 patients) or
daily placebo (16 patients)and their sperm characteristics were examined at intervals,
starting from the beginning of the study until when it ended 282 weeks later. The patients
were also monitored for adverse events throughout the period. The data form all the patients
that took part in the random allocation of treatments at the beginning of the study were
included in the analysis that followed, irrespective of whether they completed the study or
not.