A Prospective Observational Study of the Impact of a Recent Past COVID-19 Infection on the Live Birth Rates of Frozen Embryo Transfer Cycles

ShangHai Ji Ai Genetics & IVF Institute1 site in 1 country820 target enrollmentFebruary 23, 2023

ConditionsCOVID-19 Frozen Embryo Transfer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: ShangHai Ji Ai Genetics & IVF Institute
Enrollment: 820
Locations: 1
Primary Endpoint: live birth rate
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective observational study. In this study, we aim to investigate the effect of a recent past Covid-19 infection on the live birth rate in the frozen embryo transfer cycles

Registry

clinicaltrials.gov

Start Date

February 23, 2023

End Date

February 1, 2025

Last Updated

11 months ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization
•Women have embryos frozen prior to COVID infection.

Exclusion Criteria

•Previous COVID infection before oocyte retrieval
•Recipient of oocyte donation
•Undergoing preimplantation genetic testing
•Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Outcomes

Primary Outcomes

live birth rate

Time Frame: a live birth after 22 weeks gestation

live birth rate of the frozen embryo transfer cycle (\>22 weeks of gestation)

Secondary Outcomes

ectopic pregnancy(ectopic pregnancy during 12 weeks gestation)
serum COVID-19 antibody level(7 days before embryo transfer)
multiple pregnancy(multiple pregnancy beyond gestation 12 weeks)
serum hCG level(a blood pregnancy test is performed 14 days after the embryo transfer)
ongoing pregnancy(viable pregnancy beyond gestation 12 weeks)
biochemical pregnancy(positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation)
miscarriage(the loss of a pregnancy before 22 weeks gestation)
birth weight(a live birth after 22 weeks gestation)
implantation rate(number of gestational sacs per embryo transferred during 4 weeks of pregnancy)
clinical pregnancy(presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy)