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

June 22, 2022 updated by: Hillel Yaffe Medical Center

Investigating the Impact of Lifestyle on Telomere Length and Telomerase Activity on Sperm Cells Originating From Infertile Men Undergoing IVF Treatment

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Infertile men attending a university-affiliated IVF Unit at Hillel Yaffe Medical Center

Description

Inclusion Criteria:

  • Infertile couple

Exclusion Criteria:

  • Chronic disease
  • Azoospermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Ofer Limonad, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2019

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 22, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0120-18-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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