Covid-19NCT05212506
Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index
An observational study of Covid-19 and IgG Antibody, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
Trial summary
Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection. Read more about this study
- Who is it for?
- Ages 22 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Covid-19, IgG Antibody, Semen Index
- What is being tested?
- vaccinated and unvaccinated
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2022to May 2022
- 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 22 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The man's semen quality is normal and has been injected covid-19 vaccine
Who may be able to join
- The man's semen quality is normal,
- The couple meets the indications for IVF,
- injected with the covid-19 vaccine
Who cannot join
- In vitro fertilization due to male factors
- Azoospermia
- The quality of the man's semen is abnormal
- unvacced
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai First Maternity and Infant Health Hospital
Shanghai
qiang yan1, 18205184018, 602172356@qq.com
About this study
Official title: Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men
Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection.
Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients
- Conditions
- Covid-19, IgG Antibody, Semen Index
- Being tested
- vaccinated and unvaccinated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaccinated and unvaccinatedBiological
the vaccinated :Male patients who received more than 2 injections of the covid-19 vaccine;the unvaccinated :Male patients who did not receive the covid-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| vaccinated and unvaccinated | Not described Receives: Biological: vaccinated and unvaccinated |
What is being measured
The primary outcome is the main question the study is designed to answer.
semen index
the semen index of the participants
Measured: 2022.01-2022.03
Secondary outcomes (3)
Fertilization rate
The percentage of eggs fertilized
Measured: 2022.01-2022.04
embryo quality
Grading of formed embryos
Measured: 2022.02-2022.05
clinical pregnant rate
after the embryo transplantation, calculate the pregnancy rate
Measured: 2022.03-2022.05
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study startJan 2022 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai First Maternity and Infant Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, chen zhi qin, Shanghai First Maternity and Infant Hospital
- Investigators
- zhiqin chen1, Study director, covid-19 vaccine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212506
- Sponsor's protocol ID
- chen008
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men
- ClinicalTrials.gov ID
- NCT05212506
- Acronym / sponsor ID
- chen008
- Conditions
- Covid-19, IgG Antibody, Semen Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai First Maternity and Infant HospitalUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 28 Jan 2022 (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.
Since December 2019, more and more cases of unexplained pneumonia appeared after exposure to the South China Seafood Market in Wuhan City, Hubei Province. Later, the disease were confirmed to be acute respiratory infectious diseases caused by the 2019 new coronavirus infection.
Even though we have had great victories in the war against this pandemic, there is still a very large number of deaths early on. As research progresses, vaccines for this infectious disease are already being developed. There are currently two vaccines in widespread use worldwide: mRNA vaccines and inactivated vaccines. In China, inactivated vaccines are more commonly used. At present, some studies believe that mRNA vaccine does not affect the pregnancy rate and abortion rate of women, but the study sample size is small, and the conclusions are limited. The effects of inactivated vaccines on fertility are still in the blank. We now hope to conduct prospective studies, mainly to study the effect of inactivated vaccine injection on male semen, and whether it has an effect on the quality of embryos in IVF patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaccinated and unvaccinated | – | Biological: vaccinated and unvaccinated |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The man's semen quality is normal and has been injected covid-19 vaccine
Key inclusion criteria (3 listed)
- The man's semen quality is normal,
- The couple meets the indications for IVF,
- injected with the covid-19 vaccine
Key exclusion criteria (4 listed)
- In vitro fertilization due to male factors
- Azoospermia
- The quality of the man's semen is abnormal
- unvacced
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 |
|---|---|---|
| vaccinated and unvaccinatedthe vaccinated :Male patients who received more than 2 injections of the covid-19 vaccine;the unvaccinated :Male patients who did not receive the covid-19 vaccine | Biological | vaccinated and unvaccinated |
Primary outcome
semen index
Time frame: 2022.01-2022.03
the semen index of the participants
3 secondary outcomes
Fertilization rate
Time frame: 2022.01-2022.04
embryo quality
Time frame: 2022.02-2022.05
clinical pregnant rate
Time frame: 2022.03-2022.05
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Undecided
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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.
zhiqin chen1 study director
covid-19 vaccine
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 Covid-19 and IgG Antibody, run by Shanghai First Maternity and Infant Hospital at 1 site in China.
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 3 inclusion and 4 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 28 Jan 2022. 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 China. 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 qiang yan (18205184018, 602172356@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
semen index (time frame: 2022.01-2022.03). 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 28 Jan 2022.