Correlation Analysis of Covid-19 IgG Antibody Level in Seminal Plasma and Semen Index

• Conditions: Semen Index; IgG Antibody; Covid-19
• Interventions: Biological: vaccinated and unvaccinated

• Registration Number: NCT05212506
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-01
• Study Start: 2022-01
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Primary Completion: 2022-03-31
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

1. In vitro fertilization due to male factors
2. Azoospermia
3. The quality of the man's semen is abnormal
4. unvacced

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
vaccinated and unvaccinated	vaccinated and unvaccinated	-

Primary Outcome Measures

Name	Time	Method
semen index	2022.01-2022.03	the semen index of the participants

Secondary Outcome Measures

Name	Time	Method
embryo quality	2022.02-2022.05	Grading of formed embryos
clinical pregnant rate	2022.03-2022.05	after the embryo transplantation, calculate the pregnancy rate
Fertilization rate	2022.01-2022.04	The percentage of eggs fertilized

Trial Locations

Locations (1)

Shanghai First Maternity and Infant Health Hospital; 🇨🇳 Shanghai, China