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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
Sponsor:
Information provided by (Responsible Party):
Dr. Jigal Haas MD, Sheba Medical Center

Brief 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.

Condition or disease Intervention/treatment
Covid19 Fertility Issues Other: Sperm collection

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort Intervention/treatment
Vaccinated Men
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.




Primary Outcome Measures :
  1. Sperm Concentration (10^6/ml) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Semen concentration (10^6/ml)

  2. Sperm Motility (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Sperm percentage with proper forward progression

  3. 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

  4. Sperm Morphology (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Sperm morphology (%)

  5. Sperm Vitality (%) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Sperm vitality (%)

  6. Semen Liquefaction (normal/abnormal) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Macroscopic appearance - Semen liquefaction appearance

  7. Semen Viscosity (normal/abnormal) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Macroscopic appearance - Semen viscosity appearance

  8. Semen Color [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Macroscopic appearance - Semen color appearance

  9. Semen PH [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Semen PH

  10. Semen Volume (ml) [ Time Frame: 1-2 months after the second COVID-19 vaccine ]
    Semen Volume (ml)


Biospecimen Retention:   Samples Without DNA
Semen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jigal Haas, MD 972-54-6975372 jigal.haas@sheba.health.gov.il
Contact: Dror Lifshitz, MD 972-50-4645474 dror_lifshitz@hotmail.com

Locations
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Israel
Sheba medical center Recruiting
Ramat Gan, Israel
Contact: Jigal Haas, M.D    0972524651054    jigalh@hotmail.com   
Principal Investigator: Jigal Haas, M.D         
Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Dr. Jigal Haas MD, Senior Gynecologist and Obstetrician, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04778033    
Other Study ID Numbers: SHEBA - 21 - 8079- JH - CTIL
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: March 2, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infertility
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases