Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine
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|ClinicalTrials.gov Identifier: NCT04778033|
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : March 2, 2021
|Condition or disease||Intervention/treatment|
|Covid19 Fertility Issues||Other: Sperm collection|
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.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||The Effect of BNT162b2 mRNA COVID-19 Vaccine on Semen Analysis Parameters Among 75 Fertile Men|
|Actual Study Start Date :||February 9, 2021|
|Estimated Primary Completion Date :||April 10, 2021|
|Estimated Study Completion Date :||May 1, 2021|
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) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Semen concentration (10^6/ml)
- Sperm Motility (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Sperm percentage with proper forward progression
- White Blood Cells (10^6/ml) in Semen [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Amount of white blood cells (10^6/ml) in semen
- Sperm Morphology (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Sperm morphology (%)
- Sperm Vitality (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Sperm vitality (%)
- Semen Liquefaction (normal/abnormal) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Macroscopic appearance - Semen liquefaction appearance
- Semen Viscosity (normal/abnormal) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Macroscopic appearance - Semen viscosity appearance
- Semen Color [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Macroscopic appearance - Semen color appearance
- Semen PH [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Semen PH
- Semen Volume (ml) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]Semen Volume (ml)
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778033
|Contact: Jigal Haas, MDfirstname.lastname@example.org|
|Contact: Dror Lifshitz, MDemail@example.com|
|Sheba medical center||Recruiting|
|Ramat Gan, Israel|
|Contact: Jigal Haas, M.D 0972524651054 firstname.lastname@example.org|
|Principal Investigator: Jigal Haas, M.D|