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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05212506
• Other study ID #: chen008
• Status: Recruiting
• Start date: January 2022
• Est. completion date: May 2022

Study information

• Verified date: January 2022
• Source: Shanghai First Maternity and Infant Hospital
• Contact: qiang yan
• Phone: 18205184018
• Email: 602172356[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 22 Years to 50 Years

Eligibility

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

Exclusion Criteria:

1. In vitro fertilization due to male factors

2. Azoospermia

3. The quality of the man's semen is abnormal

4. unvacced

Related Conditions & MeSH terms

• Covid-19

Intervention

Biological:
• vaccinated and unvaccinated
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

Locations

Country	Name	City	State
China	Shanghai First Maternity and Infant Health Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	semen index	the semen index of the participants	2022.01-2022.03
Secondary	Fertilization rate	The percentage of eggs fertilized	2022.01-2022.04
Secondary	embryo quality	Grading of formed embryos	2022.02-2022.05
Secondary	clinical pregnant rate	after the embryo transplantation, calculate the pregnancy rate	2022.03-2022.05