Covid19NCT04778033
Semen Analysis Parameters Following Pfizer's COVID-19 Vaccine
An observational study of Covid19 and Fertility Issues, run by Sheba Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid19, Fertility Issues
- What is being tested?
- Sperm collection
- Type of treatment
- Vaccines
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Feb 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine
Who may be able to join
- 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.
Who cannot join
- Known abnormal semen parameters.
- Age above 45.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba medical center
Ramat Gan
Jigal Haas, M.D, 0972524651054, jigalh@hotmail.com
Jigal Haas, M.D
About this study
Official title: The Effect of BNT162b2 mRNA COVID-19 Vaccine on Semen Analysis Parameters Among 75 Fertile Men
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.
Read the 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.
- Conditions
- Covid19, Fertility Issues
- Being tested
- Sperm collection
- Medical subject headings
- COVID-19, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm collectionOther
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 group | Role | What they receive |
|---|---|---|
| Vaccinated Men | Fertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine Receives: Other: Sperm collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm Concentration (10^6/ml)
Semen concentration (10^6/ml)
Measured: 1-2 months after the second COVID-19 vaccine
Sperm Motility (%)
Sperm percentage with proper forward progression
Measured: 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
Measured: 1-2 months after the second COVID-19 vaccine
Sperm Morphology (%)
Sperm morphology (%)
Measured: 1-2 months after the second COVID-19 vaccine
Sperm Vitality (%)
Sperm vitality (%)
Measured: 1-2 months after the second COVID-19 vaccine
Semen Liquefaction (normal/abnormal)
Macroscopic appearance - Semen liquefaction appearance
Measured: 1-2 months after the second COVID-19 vaccine
Semen Viscosity (normal/abnormal)
Macroscopic appearance - Semen viscosity appearance
Measured: 1-2 months after the second COVID-19 vaccine
Semen Color
Macroscopic appearance - Semen color appearance
Measured: 1-2 months after the second COVID-19 vaccine
Semen PH
Semen PH
Measured: 1-2 months after the second COVID-19 vaccine
Semen Volume (ml)
Semen Volume (ml)
Measured: 1-2 months after the second COVID-19 vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start9 Feb 2021
- Primary completion10 Apr 2021 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Jigal Haas MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778033
- Sponsor's protocol ID
- SHEBA - 21 - 8079- JH - CTIL
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BNT162b2 mRNA COVID-19 Vaccine on Semen Analysis Parameters Among 75 Fertile Men
- ClinicalTrials.gov ID
- NCT04778033
- Acronym / sponsor ID
- SHEBA - 21 - 8079- JH - CTIL
- Conditions
- Covid19, Fertility Issues
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 10 Apr 2021 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccinated Men | – | Other: Sperm collectionFertile men who were vaccinated with the BNT162b2 COVID-19 Vaccine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Fertile men 1-2 months following the second dose of BNT162b2 COVID-19 Vaccine
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Known abnormal semen parameters.
- Age above 45.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm collectionThose 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. | Other | Vaccinated Men |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Fertility Issues, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jigal Haas, MD (972-54-6975372, jigal.haas@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm Concentration (10^6/ml) (time frame: 1-2 months after the second COVID-19 vaccine). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.