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

NCT01409837 | Completed Phase 2 Results DMC

• 1 other identifier: GHF/GrS/99/S.3
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oligospermia

Keywords

Oligospermia; Male infertility; Lisinopril

Outcome Measures

Primary Outcomes (8)

• Changes From Baseline in the Seminal Fluid Characteristics Throughout the Study

  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.

  Week 96.

• Total Sperm Cell Count Per Milliliter of Seminal Fluid.

  the number of sperm cells counted per milliliter volume of seminal fluid

  Week 96

• Proportion of Sperm Cells With Normal Motility (%)

  This was determined as the proportion (percent) of the total sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.

  Week 96

• Proportion of Sperm Cells With Abnormal Morphology (%)

  Proportion (per cent) of sperm cells with abnormal appearance

  Week 96

• Ejaculate Volume

  The volume in milliliters of seminal fluid produced per ejaculation.

  Week 282

• Total Sperm Cell Count

  The total number of sperm cells found in each milliliter of seminal fluid.

  Week 282

• Proportion of Sperm Cells With Normal Motility (%)

  The proportion (per cent) of the sperm cells exhibiting both rhythmic and propulsive movements considered to be of normal intensity.

  Week 282

• Proportion of Sperm Cells With Abnormal Morphology (%)

  The proportion (per cent) of the total number of sperm cell with abnormal appearance.

  Week 282

Secondary Outcomes (1)

• Adverse Events Monitoring

  At weeks 6, 12, 24, 48, 96, 102, 114,138, 186 and 282

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Started with Placebo until the crossover.

Lisinopril

EXPERIMENTAL

Started with Lisinopril until the crossover

Drug: Lisinopril

Interventions

Lisinopril DRUG

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.

Also known as: (Zestril®, AstraZeneca Pharmaceuticals,Washington NC, USA)

Lisinopril

Eligibility Criteria

• Age: 24 Years - 34 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients who did not give their consent to participate
• did not meet the diagnostic criteria for oligospermia at the time of recruitment

Sponsors & Collaborators

• University Of Nigeria Teaching Hospital: lead

Study Sites (1)

University of Nigeria Teaching Hospital, Ituku-Ozalla,

Enugu, Enugu State, 01129, Nigeria

Location

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MeSH Terms

Conditions

Oligospermia; Infertility, Male

Interventions

Lisinopril

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Anthony Mbah, Principal investigator
• Organization: University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu

cmd_unth@yahoo.com

2348051519065

Study Officials

• Anthony U Mbah, MD, FMCP

  University of Nigeria Teaching Hospital, Ituku-Ozalla, Enugu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 4, 2011
• Study Start: March 1, 1998
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: November 25, 2013
• Results First Posted: November 25, 2013

Record last verified: 2013-09

Locations

NG (1)