Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine

NCT04778033 | Unknown

• 1 other identifier: SHEBA - 21 - 8079- JH - CTIL
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Fertility Issues

Outcome Measures

Primary Outcomes (10)

• Sperm Concentration (10^6/ml)

  Semen concentration (10\^6/ml)

  1-2 months after the second COVID-19 vaccine

• Sperm Motility (%)

  Sperm percentage with proper forward progression

  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

  1-2 months after the second COVID-19 vaccine

• Sperm Morphology (%)

  Sperm morphology (%)

  1-2 months after the second COVID-19 vaccine

• Sperm Vitality (%)

  Sperm vitality (%)

  1-2 months after the second COVID-19 vaccine

• Semen Liquefaction (normal/abnormal)

  Macroscopic appearance - Semen liquefaction appearance

  1-2 months after the second COVID-19 vaccine

• Semen Viscosity (normal/abnormal)

  Macroscopic appearance - Semen viscosity appearance

  1-2 months after the second COVID-19 vaccine

• Semen Color

  Macroscopic appearance - Semen color appearance

  1-2 months after the second COVID-19 vaccine

• Semen PH

  Semen PH

  1-2 months after the second COVID-19 vaccine

• Semen Volume (ml)

  Semen Volume (ml)

  1-2 months after the second COVID-19 vaccine

Study Arms (1)

Vaccinated Men

Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine

Other: Sperm collection

Interventions

Sperm collection OTHER

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.

Vaccinated Men

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine

You may qualify if:

• Previously impregnated their partner without the use of assisted reproduce technology, or previously had a normal sperm analysis exam by WHO 2010 criteria.
• months following the second dose of BNT162b2 COVID-19 Vaccine.

You may not qualify if:

• Known abnormal semen parameters.
• Age above 45.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Semen

MeSH Terms

Conditions

COVID-19; Infertility

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Genital Diseases; Urogenital Diseases

Central Study Contacts

Jigal Haas, MD

CONTACT

972-54-6975372; jigal.haas@sheba.health.gov.il

Dror Lifshitz, MD

CONTACT

972-50-4645474; dror_lifshitz@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Gynecologist and Obstetrician

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 2, 2021
• Study Start: February 9, 2021
• Primary Completion: April 10, 2021
• Study Completion: May 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)