Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine
NCT ID: NCT04778033
Last Updated: 2021-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
75 participants
OBSERVATIONAL
2021-02-09
2021-05-01
Brief Summary
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Detailed Description
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The newly available mRNA COVID 19 vaccine by Pfizer was recently evaluated in a large multicenter placebo controlled RCT. The vaccine is comprised of BNT162b2, a lipid nanoparticle formulated nucleoside-modified RNA (modRNA) encoding the SARS-CoV2 full length spike protein, modified by two Proline mutations. The two 20 µg doses were shown to elicit high SARS-COV2 neutralizing antibody titers alongside high antigen specific CD8+ and Th1 type CD4+ T cell response. It was subsequently shown to be 95% effective in preventing COVID-19 infection a week following the second dose with a favorable safety profile in a 2-month median following up time.
Unfounded claims in the popular media linked a possible correlation between the COVID-19 vaccine and potential female\\male infertility. Currently. there is no information in the medical literature which examined semen analysis parameters following the COVD-19 vaccine.
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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vaccinated Men
Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine
Sperm collection
Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. The sample will be analyzed for macroscopic and microscopic features in the IVF laboratory and will be discarded immediately afterwards.
Interventions
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Sperm collection
Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. The sample will be analyzed for macroscopic and microscopic features in the IVF laboratory and will be discarded immediately afterwards.
Eligibility Criteria
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Inclusion Criteria
* 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine.
Exclusion Criteria
* Age above 45.
18 Years
45 Years
MALE
Yes
Sponsors
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Sheba Medical Center
OTHER_GOV
Responsible Party
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Dr. Jigal Haas MD
Senior Gynecologist and Obstetrician
Locations
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Sheba medical center
Ramat Gan, , Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHEBA - 21 - 8079- JH - CTIL
Identifier Type: -
Identifier Source: org_study_id
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