The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count
Condition: Oligospermia
MeSH terms: Infertility; Oligospermia
Intervention: Lisinopril
Intervention description: The two groups of patients, A and B, were randomly allocated treatments in a double-blind fashion. Group A was started on the coded drug "DY1" while group B was started on the coded drug "DZ2". Both "DY1" and "DZ2" were very identical in appearance. At week 96 the drugs were swopped between the groups such that group A changed to drug "DZ2" while group B changed to drug "DY1". There was no intervening washout period. The codes were concealed until after the data analysis.
Intervention MeSH terms: Lisinopril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: Male
Minimum age: 24 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: Oligospermia; Male infertility; Lisinopril

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.
    

Eligibility 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.