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Clinical Trials/NCT05212506
NCT05212506UnknownNot Applicable

Association of Seminal Plasma SARS-Cov19 IgG Level With Semen Parameters and Embryological Characteristics in Vaccinated Normozoospermic Men

Shanghai First Maternity and Infant Hospital1 site in 1 country100 target enrollmentStarted: January 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
1
Primary Endpoint
semen index

Study Overview

Brief 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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
22 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •The man's semen quality is normal,
  • •The couple meets the indications for IVF,
  • •injected with the covid-19 vaccine

Exclusion Criteria

  • •In vitro fertilization due to male factors
  • •Azoospermia
  • •The quality of the man's semen is abnormal

Outcomes

Primary Outcomes

semen index

Time Frame: 2022.01-2022.03

the semen index of the participants

Secondary Outcomes

  • embryo quality(2022.02-2022.05)
  • clinical pregnant rate(2022.03-2022.05)
  • Fertilization rate(2022.01-2022.04)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

chen zhi qin

doctor

Shanghai First Maternity and Infant Hospital

Study Sites (1)

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