Male InfertilityNCT04158765
The Impact of Lifestyle on Sperm Telomere Length and Telomerase Activity in Men Undergoing IVF Treatments
An observational study of Male Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 20 Nov 2019to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Infertile men attending a university-affiliated IVF Unit at Hillel Yaffe Medical Center
Who may be able to join
- Infertile couple
Who cannot join
- Chronic disease
- Azoospermia
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hille Yaffe Medical Center
Hadera, 3810101
Ofer Limonad, MD, oferlimonad@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Male Infertility
- Being tested
- DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).Other
DNA will be extracted from sperm using the DNeasy Tissue Kit and Telomerase activity in samples will be measured using a PCR- based assay.
| Study group | Role | What they receive |
|---|---|---|
| Infertile men | Men with altered spermograms (isolated teratozoospermia or oligo-astheno-teratozoospermia) Receives: Other: DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telomere length
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start20 Nov 2019
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ofer Limonad, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158765
- Sponsor's protocol ID
- 0120-18-HYMC
- Status last verified
- Jun 2022
- First submitted
- 23 Jul 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Lifestyle on Telomere Length and Telomerase Activity on Sperm Cells Originating From Infertile Men Undergoing IVF Treatment
- ClinicalTrials.gov ID
- NCT04158765
- Acronym / sponsor ID
- 0120-18-HYMC
- Conditions
- Male Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile men | – | Other: DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).Men with altered spermograms (isolated teratozoospermia or oligo-astheno-teratozoospermia) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Infertile men attending a university-affiliated IVF Unit at Hillel Yaffe Medical Center
Key inclusion criteria (1 listed)
- Infertile couple
Key exclusion criteria (2 listed)
- Chronic disease
- Azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Infertile men |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ofer Limonad, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Limonad, MD (972-52-5322972, oferlimonad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Telomere length (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.