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The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count

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ClinicalTrials.gov Identifier: NCT01409837
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Oligospermia
Intervention: Drug: Lisinopril

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
As per protocol the recruitment of patients took place from March 1998 to September 2001 while the actual investigation took place from January 2002 to December 2006.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the recruitment period a total of 131 male patients being treated for low sperm count of unknown cause volunteered to participate. They were screened based on the criteria for eligibility as per protocol. Only 33 (25.2%) satisfied the inclusion criteria and were randomized such that 16 were in group A while 17 were in group B.

Reporting Groups
Group B (Lisinopril First, Then Placebo) Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
Group A (Placebo First, Then Lisinopril) Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.

Participant Flow:   Overall Study
    Group B (Lisinopril First, Then Placebo)   Group A (Placebo First, Then Lisinopril)
STARTED   17   16 
6th Week   17   16 
12th Week   16 [1]   16 
24th Week   16   15 [2] 
48th Week   15 [3]   15 
96th Week   15   15 
102nd Week   15   14 [4] 
114th Week   15   14 
138th Week   15   14 
186th Week   14 [1]   14 
282nd Week   14   14 
COMPLETED   14   14 
Withdrawal by Subject                2                1 
Lost to Follow-up                1                0 
Physician Decision                0                1 
[1] Moved away to another location
[2] Diagnosed with Lymphocytic Lymphoma and withdrawn
[3] Lost to follow-up
[4] Married another wife

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Group B (Lisinopril First, Then Placebo) Started with Lisinopril, crossed over to Placebo
Group A (Placebo First, Then Lisinopril) Started with Sugar Pill, crossed over to Lisinopril
Total Total of all reporting groups

Baseline Measures
   Group B (Lisinopril First, Then Placebo)   Group A (Placebo First, Then Lisinopril)   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
[Units: Years]
Mean (Standard Deviation)
Between 18 and 65 years   30.86  (8.8)   26.93  (7.3)   28.895  (8.05) 
[Units: Participants]
Female   0   0   0 
Male   17   16   33 
Region of Enrollment 
[Units: Participants]
Nigeria   17   16   33 
[Units: Metres]
Mean (Standard Deviation)
 1.51  (0.4)   1.48  (0.5)   1.495  (0.45) 
[Units: Kg]
Mean (Standard Deviation)
 66.19  (11.2)   64.26  (10.3)   65.225  (10.75) 
Duration of infertility 
[Units: Years]
Mean (Standard Deviation)
 8.20  (4.3)   7.77  (3.1)   7.789  (3.7) 
Ejaculate volume 
[Units: Ml]
Geometric Mean (Standard Deviation)
 3.09  (0.34)   3.01  (0.23)   3.05  (0.29) 
Sperm cell count 
[Units: Millions/ml]
Geometric Mean (Standard Deviation)
 5.29  (2.6)   7.43  (3.97)   6.36  (3.29) 
Sperm cell motility (%) 
[Units: Per cent]
Geometric Mean (Standard Deviation)
 17.33  (3.2)   22.12  (4.4)   19.73  (3.8) 
Sperm cells with abnormal morphology (%) 
[Units: Per cent]
Geometric Mean (Standard Deviation)
 42.91  (5.1)   44.12  (2.6)   43.52  (3.85) 

  Outcome Measures

1.  Primary:   Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study   [ Time Frame: Week 96. ]

2.  Primary:   Total Sperm Cell Count Per Milliliter of Seminal Fluid.   [ Time Frame: Week 96 ]

3.  Primary:   Proportion of Sperm Cells With Normal Motility (%)   [ Time Frame: Week 96 ]

4.  Primary:   Proportion of Sperm Cells With Abnormal Morphology (%)   [ Time Frame: Week 96 ]

5.  Primary:   Ejaculate Volume   [ Time Frame: Week 282 ]

6.  Primary:   Total Sperm Cell Count   [ Time Frame: Week 282 ]

7.  Primary:   Proportion of Sperm Cells With Normal Motility (%)   [ Time Frame: Week 282 ]

8.  Primary:   Proportion of Sperm Cells With Abnormal Morphology (%)   [ Time Frame: Week 282 ]

9.  Secondary:   Adverse Events Monitoring   [ Time Frame: At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The sample size of the study is small thereby limiting the reliability of generalizing the findings. In addition, three subjects who started the study terminated prematurely and it is difficult to assess how this fact has affected the study results.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Anthony Mbah, Principal investigator
Organization: University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu
phone: 2348051519065
e-mail: cmd_unth@yahoo.com

Mbah AU. Normogonadotrophic, non-obstructive azoospermia: successful treatment of two cases using low-dose lisinopril (Abstract): 24th Annual Scientific Conference of the Association of Physicians of Nigeria. Port Harcourt, 1999.
World Health Organization, WHO Laboratory Manual for the Examination of Human Semen and Sperm-Cervical Mucus Interactions. 4th ed. Cambridge, United Kingdom: Cambridge University Press; 1999.
Clinical diagnosis by laboratory method. Davidson I, Henry JB (eds), ELBS, NewYork, 1979), pp. 340-500.
SPSS Reference Guide. SPSS Inc. Chicago, IL, U.S.A. 1990

Responsible Party: Dr. Mbah Anthony Uche, University Of Nigeria Teaching Hospital
ClinicalTrials.gov Identifier: NCT01409837     History of Changes
Other Study ID Numbers: GHF/GrS/99/S.3
First Submitted: August 2, 2011
First Posted: August 4, 2011
Results First Submitted: June 22, 2013
Results First Posted: November 25, 2013
Last Update Posted: November 25, 2013