The Effect of Covid-19 Vaccination in Patients Undergoing IVF (Covid-19)

September 30, 2021 updated by: chen zhi qin, Shanghai First Maternity and Infant Hospital

Does Covid-19 Vaccination in Patients Undergoing in Vitro Fertilization Affect the Live Birth Rate of Their First Embryo Transfer Cycle: A Prospective Cohort Study

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

712

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing IVF with and without COVID- 19 vaccination.

Description

Inclusion Criteria:

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate per transfer
Time Frame: 10 month
A baby born alive after 22 weeks gestation was classified as a live birth
10 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai First Maternity and Infant Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 30, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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