The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count
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Purpose
This study was conceived in order to explain what the investigators previously observed the suggested 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 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 were only a few previous studies done in humans. Besides, the method of 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 were 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Oligospermia |
Drug: Lisinopril |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 5-year Prospective, Placebo-controlled, Crossover Evaluation of the Efficacy and Tolerability of Low-dose Lisinopril in Normotensives With Idiopathic Oligospermic Infertility |
- Changes from baseline in the seminal fluid characteristics throughout the study [ Time Frame: At weeks 0, 6, 12, 24, 48, 96, 102, 114, 138, 186, 282. ] [ Designated as safety issue: No ]The seminal fluid characteristics were assessed twice before the entry of each patient and both at least two-weeks apart. The two values were averaged and recorded as baseline for week 0 while subsequent changes from the baseline were monitored during each of the scheduled visits at weeks 6, 12, 24, 48, 96, 102, 114, 138, 186 and 282. The two groups swopped treatments at the 96th week. The number of pregnancies achieved was also documented throughout the study period.
- Adverse events monitoring [ Time Frame: At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282 ] [ Designated as safety issue: Yes ]The patients were encouraged to report every event promptly by phone to one of the authors (NOG), no matter however minor.Blood pressure measurements were done with mercury sphygmomanometers fitted with adult-size cuffs (Accoson, England). Serum potassium levels were estimated using the flame photometric method as described by Davidson and Henry
| Enrollment: | 33 |
| Study Start Date: | March 1998 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar pill |
Drug: Lisinopril
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.
Other Name: (Zestril®, AstraZeneca Pharmaceuticals,Washington NC, USA)
|
| Experimental: Lisinopril |
Drug: Lisinopril
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.
Other Name: (Zestril®, AstraZeneca Pharmaceuticals,Washington NC, USA)
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 24 Years to 34 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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 oligo-astheno-teratospermia 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 oligo-astheno-teratospermia at the time of recruitment
- failed to fulfil any of the above inclusion criteria, even if the diagnostic criteria are fulfilled.
Contacts and Locations| Nigeria | |
| University of Nigeria Teaching Hospital, Ituku-Ozalla, | |
| Enugu, Nigeria, 01129 | |
| Principal Investigator: | Anthony U Mbah, MD, FMCP | University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu |
More Information
Publications:
| Responsible Party: | Dr. Mbah Anthony Uche, University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu |
| ClinicalTrials.gov Identifier: | NCT01409837 History of Changes |
| Other Study ID Numbers: | GHF/GrS/99/S.3 |
| Study First Received: | August 2, 2011 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Nigeria: The National Agency for Food and Drug Administration and Control |
Keywords provided by University Of Nigeria Teaching Hospital:
|
Oligospermia Male infertility Lisinopril |
Additional relevant MeSH terms:
|
Infertility Oligospermia Genital Diseases, Male Genital Diseases, Female Infertility, Male Lisinopril Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Cardiotonic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013