The Impact of Past Coronavirus Disease 19 (COVID-19) Infection on the Live Birth Rates of Frozen Embryo Transfer Cycles

Study Overview
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Brief Summary
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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

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

Conditions
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COVID-19, Frozen Embryo Transfer

Intervention / Treatment
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* Other: frozen embryo transfer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 infection group<br>Infertile women attending for frozen embryo transfer with a recent past COVID-19 infection | Other: frozen embryo transfer<br>* transfer one or two embryos in frozen embryo transfer cycles<br>|
| Control group<br>Infertile women attending for frozen embryo transfer without a recent past COVID-19 infection | Other: frozen embryo transfer<br>* transfer one or two embryos in frozen embryo transfer cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | live birth rate of the frozen embryo transfer cycle (>22 weeks of gestation) | a live birth after 22 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum hCG level | serum hCG level | a blood pregnancy test is performed 14 days after the embryo transfer | 
| clinical pregnancy | presence of intrauterine gestational sac on ultrasound | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy | 
| ongoing pregnancy | viable pregnancy beyond gestation 12 weeks | viable pregnancy beyond gestation 12 weeks | 
| biochemical pregnancy | positive blood pregnancy test not followed by clinical pregnancy | positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation | 
| implantation rate | number of gestational sacs per embryo transferred | number of gestational sacs per embryo transferred during 4 weeks of pregnancy | 
| multiple pregnancy | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks | 
| ectopic pregnancy | pregnancy outside the uterine cavity | ectopic pregnancy during 12 weeks gestation | 
| miscarriage | the loss of a pregnancy before 22 weeks gestation | the loss of a pregnancy before 22 weeks gestation | 
| birth weight | birth weight of the baby delivered | a live birth after 22 weeks gestation | 
| serum COVID-19 antibody level | serum COVID-19 antibody level immunoglobulin G and immunoglobulin M | 7 days before embryo transfer |