The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count
|ClinicalTrials.gov Identifier: NCT01409837|
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Oligospermia||Drug: Lisinopril||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||March 1998|
|Primary Completion Date :||December 2006|
|Study Completion Date :||December 2006|
Placebo Comparator: Sugar pill
Started with Placebo until the crossover.
Started with Lisinopril until the crossover
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)
- Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study [ Time Frame: Week 96. ]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.
- Total Sperm Cell Count Per Milliliter of Seminal Fluid. [ Time Frame: Week 96 ]the number of sperm cells counted per milliliter volume of seminal fluid
- Proportion of Sperm Cells With Normal Motility (%) [ Time Frame: Week 96 ]This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.
- Proportion of Sperm Cells With Abnormal Morphology (%) [ Time Frame: Week 96 ]Proportion (per cent) of sperm cells with abnormal appearance
- Ejaculate Volume [ Time Frame: Week 282 ]The volume in milliliters of seminal fluid produced per ejaculation.
- Total Sperm Cell Count [ Time Frame: Week 282 ]The total number of sperm cells found in each milliliter of seminal fluid.
- Proportion of Sperm Cells With Normal Motility (%) [ Time Frame: Week 282 ]The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.
- Proportion of Sperm Cells With Abnormal Morphology (%) [ Time Frame: Week 282 ]The proportion (per cent) of the total number of sperm cell with abnormal appearance.
- Adverse Events Monitoring [ Time Frame: At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409837
|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|