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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

Tracking Information
First Submitted Date February 8, 2021
First Posted Date March 2, 2021
Last Update Posted Date March 2, 2021
Actual Study Start Date February 9, 2021
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 27, 2021)
  • 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)
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine
Official Title The Effect of BNT162b2 mRNA COVID-19 Vaccine on Semen Analysis Parameters Among 75 Fertile Men
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Semen
Sampling Method Non-Probability Sample
Study Population Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine
Condition
  • Covid19
  • Fertility Issues
Intervention 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.
Study Groups/Cohorts Vaccinated Men
Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine
Intervention: Other: Sperm collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 27, 2021)
75
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date April 10, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jigal Haas, MD 972-54-6975372 jigal.haas@sheba.health.gov.il
Contact: Dror Lifshitz, MD 972-50-4645474 dror_lifshitz@hotmail.com
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04778033
Other Study ID Numbers SHEBA - 21 - 8079- JH - CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dr. Jigal Haas MD, Sheba Medical Center
Study Sponsor Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Sheba Medical Center
Verification Date February 2021