The Effect of Covid-19 Vaccination in Patients Undergoing IVF

• Conditions: Covid-19 Vaccination

• Registration Number: NCT05063942
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

Since emerging in the last months of 2019, over 127 000 000 individuals have suffered severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and the documented death toll from coronavirus disease 2019 (COVID-19) had reached 2788639 individuals globally by the end of March 2021 (CDC, 2021).It is hoped that widespread vaccination will further limit viral spread and shorten the length of the pandemic and its impact on morbidity and mortality. There are currently two vaccines against the new coronavirus: inactivated vaccines and mRNA vaccines.Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine. By the end of September 2021, 2206.054 million doses (including the first and second doses of the vaccine) of the vaccines have been fulfilled.There is still a lack of real-world data to assist clinicians in counseling their IVF patients regarding the possible impact of recent recovery from COVID infection, or vaccination against it, on the potential for success of ART. We aimed to determine the impact of confirmed COVID-19 immunization on IVF outcomes, by comparing live birth rate of the first transfer cycle in patients undergoing IVF with and without COVID- 19 vaccination.

Detailed Description

Since emerging in the last months of 2019, over 127 000 000 individuals have suffered severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and the documented death toll from coronavirus disease 2019 (COVID-19) had reached 2788639 individuals globally by the end of March 2021 (CDC, 2021).Although a major victory has been achieved in the fight against the epidemic since first case was reported in Wuhan City,, the cumulative death toll is 5,691 by the end of September in China . At the present time, mitigation strategies for controlling the pandemic continue to rely heavily on universal masking, physical distancing, limiting social interactions, and frequent sanitizing measures. It is hoped that widespread vaccination will further limit viral spread and shorten the length of the pandemic and its impact on morbidity and mortality.

There are currently two vaccines against the new coronavirus: inactivated vaccines and mRNA vaccines. Unlike inactivated vaccines, the mRNA vaccine does not use natural pathogens, but artificially synthesizes the gene sequence encoding a specific antigen protein, and then directly injects the mRNA encoding the antigen protein into the human body to induce the immune system to produce antibodies against the new coronavirus. Although some studies have shown that mRNA vaccines do not increase the risk of miscarriage in women, the conclusion is limited due to the lack of non-pregnant women as a control group. At the same time, the impact of inactivated vaccines on female pregnancy is still in a blank state. Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine vaccine. By the end of September 2021, 2206.054 million doses (including the first and second doses of the vaccine) of the vaccines have been fulfilled. We aimed to determine the impact of confirmed COVID-19 immunization on IVF outcomes, by comparing live birth rate of the first transfer cycle in patients undergoing IVF with and without COVID- 19 vaccination.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-09-30
• Last Update Submitted: 2021-09-30
• Study Start: 2021-10-01
• Study First Posted: 2021-10-01
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 712

Inclusion Criteria

Age of women <43 years at the time of ovarian stimulation for IVF

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Exclusion Criteria

1. an abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy,
2. moderate or severe endometriosis,
3. Recipient of oocyte donation and
4. Undergoing preimplantation genetic testing
5. Presence of hydrosalpinx or endometrial polyp which is not surgically treated
6. patients with poor ovarian response (less than 3 mature follicles)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
live birth rate per transfer	10 month	A baby born alive after 22 weeks gestation was classified as a live birth

Secondary Outcome Measures

Name	Time	Method
embryo implantation rate	2month	number of gestational sacs per embryo transferred
clinical pregnancy rate	4 weeks	presence of intrauterine gestational sac on ultrasound
biochemical pregnancy rate	2 weeks	positive urine pregnancy test
number of transferable embryos	2weeks	Number of oocytes retrieved and embryos/blastocysts suitable for freezing and transfer