An observational study in Covid19 and Fertility Issues, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Sheba Medical Center · Observational
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.
The 2019 novel coronavirus disease (COVID-19) is a highly infectious respiratory tract disease which was first reported in Wuhan, Hubei Province, China in Dec 2019, but has since spread globally. By march 2020 it was declared by WHO as a public health emergency pandemic and has thus far affected tens of millions worldwide. The implications of COVID 19 infection on male fertility were examined in a previous study, which found decreased sperm concentration in recovering patients compared with controls.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 75 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine
Exclusion Criteria:
Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine
Other: 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.
Sperm Concentration (10^6/ml)
Semen concentration (10\^6/ml)
Time frame: 1-2 months after the second COVID-19 vaccine
Sperm Motility (%)
Sperm percentage with proper forward progression
Time frame: 1-2 months after the second COVID-19 vaccine
White Blood Cells (10^6/ml) in Semen
Amount of white blood cells (10\^6/ml) in semen
Time frame: 1-2 months after the second COVID-19 vaccine
Sperm Morphology (%)
Sperm morphology (%)
Time frame: 1-2 months after the second COVID-19 vaccine
Sperm Vitality (%)
Sperm vitality (%)
Time frame: 1-2 months after the second COVID-19 vaccine
Semen Liquefaction (normal/abnormal)
Macroscopic appearance - Semen liquefaction appearance
Time frame: 1-2 months after the second COVID-19 vaccine
Semen Viscosity (normal/abnormal)
Macroscopic appearance - Semen viscosity appearance
Time frame: 1-2 months after the second COVID-19 vaccine
Semen Color
Macroscopic appearance - Semen color appearance
Time frame: 1-2 months after the second COVID-19 vaccine
Semen PH
Semen PH
Time frame: 1-2 months after the second COVID-19 vaccine
Semen Volume (ml)
Semen Volume (ml)
Time frame: 1-2 months after the second COVID-19 vaccine
Plan to share: No
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This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center