UnknownNot Applicable

Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine

Israel75 participantsStarted 2021-02-09

Plain-language summary

In this study the investigators will explore the effect of the BNT162b2 COVID-19 Vaccine on semen analysis parameters among 75 fertile men. Fertile men will be regarded as such if they previously successfully impregnated their partners without the use of artificial reproductive technology, or men who previously had a normal sperm analysis exam by WHO criteria (2010). Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. In addition, the participants will fill a brief questionnaire with information regarding their medical and reproductive history. The investigators will examine the macroscopic and microscopic properties of the semen samples and compare them to the WHO semen analysis reference range in an attempt to ascertain whether the vaccine influences sperm parameters.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Previously impregnated their partner without the use of assisted reproduce technology, or previously had a normal sperm analysis exam by WHO 2010 criteria. * 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine. Exclusion Criteria: * Known abnormal semen parameters. * Age above 45.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sperm Concentration (10^6/ml)

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Motility (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

White Blood Cells (10^6/ml) in Semen

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Morphology (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Vitality (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

Semen Liquefaction (normal/abnormal)

Timeframe: 1-2 months after the second COVID-19 vaccine

Semen Viscosity (normal/abnormal)

Timeframe: 1-2 months after the second COVID-19 vaccine

Trial details

NCT IDNCT04778033

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2021-04-10

Contact for this trial

Jigal Haas, MD

972-54-6975372 jigal.haas@sheba.health.gov.il

View on ClinicalTrials.gov More Covid19 trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Sperm Concentration (10^6/ml)

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Motility (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

White Blood Cells (10^6/ml) in Semen

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Morphology (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

Sperm Vitality (%)

Timeframe: 1-2 months after the second COVID-19 vaccine

Semen Liquefaction (normal/abnormal)

Timeframe: 1-2 months after the second COVID-19 vaccine

Semen Viscosity (normal/abnormal)

Timeframe: 1-2 months after the second COVID-19 vaccine