NCT05739019CompletedNot Applicable
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 enrollmentStarted: February 23, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 820
- Locations
- 1
- Primary Endpoint
- live birth rate
Study 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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)
Investigators
Study Sites (1)
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