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: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Of Nigeria Teaching Hospital
• Treatments: Lisinopril

Criteria

The subjects for this investigation were selected from a volunteer pool of male patients attending the fertility clinic of University of Nigeria Teaching Hospital, Enugu. The criteria for their selection were:

Inclusion criteria:

• regular attendance and on treatment for low sperm count or oligospermia in the fertility clinic for at least 2 years

• total sperm count at selection from 5 million/ml to 10 million/ml,

• white blood cell (WBC) count less than 1 million per ml of the ejaculate

• evidence of undergone comprehensive investigations to exclude secondary causes of low sperm count, (e) evidence of comprehensive investigations to exclude female factor infertility in the spouse

• an assurance of a personal commitment to continue participating in the study until the end-point was reached and (g) normal blood pressure.

Exclusion criteria:

• Patients who did not give their consent to participate

• did not meet the diagnostic criteria for oligospermia at the time of recruitment

• failed to fulfill any of the above inclusion criteria, even if the diagnostic criteria are fulfilled.