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The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158765
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
This aim of this study is to determine the impact of lifestyle on telomere length and telomerase enzyme activity on sperm cells of men undergoing IVF treatments.

Condition or disease Intervention/treatment
Male Infertility Other: DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).

Detailed Description:
Following approval of the study by the Hospital Ethical Committee (Helsinki), semen samples and blood will be collected from infertile individuals referred to our IVF unit at Hillel Yaffe Medical Center. Informed written consent will be obtained from each participant. Standard semen analysis will be carried out according to World Health Organization protocol. An aliquot of semen sample will be used for assessment of sperm motility, concentration, and morphology by using computer-aided sperm analysis (CASA) and the remaining sample will be used for assessment of sperm telomere lengths and telomerase activity. Genomic DNA will be extracted from the remaining washed sperm and peripheral blood. Sperm telomere length will be determined by real-time polymerase chain reaction (qRT-PCR) and telomerase activity will be determined by TRAP assay (Telomeric Repeat Amplification Protocol).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Impact of Lifestyle on Telomere Length and Telomerase Activity on Sperm Cells Originating From Infertile Men Undergoing IVF Treatment
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021


Group/Cohort Intervention/treatment
Infertile men
Men with altered spermograms (isolated teratozoospermia or oligo-astheno-teratozoospermia)
Other: DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).
DNA will be extracted from sperm using the DNeasy Tissue Kit and Telomerase activity in samples will be measured using a PCR- based assay.




Primary Outcome Measures :
  1. Telomere length [ Time Frame: Two years ]
    After laboratory determination of telomere length, results will be compared to lifestyle of subject to see whether smoking or other lifestyle behaviors have an effect


Biospecimen Retention:   Samples With DNA
Frozen sperm and whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infertile men attending a university-affiliated IVF Unit at Hillel Yaffe Medical Center
Criteria

Inclusion Criteria:

  • Infertile couple

Exclusion Criteria:

  • Chronic disease
  • Azoospermia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158765


Contacts
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Contact: Ofer Limonad, MD 972-52-5322972 oferlimonad@gmail.com

Locations
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Israel
Hille Yaffe Medical Center Recruiting
Hadera, Israel, 3810101
Contact: Ofer Limonad, MD       oferlimonad@gmail.com   
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
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Principal Investigator: Ofer Limonad, MD Hillel Yaffe Medical Center
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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT04158765    
Other Study ID Numbers: 0120-18-HYMC
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female