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

Recruiting

• Conditions: COVID-19; Frozen Embryo Transfer
• Interventions: Other: frozen embryo transfer

• Registration Number: NCT05739019
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-21
• Study First Submitted QC: 2023-02-21
• Study First Posted: 2023-02-22
• Study Start: 2023-02-23
• Status Verified: 2024-04
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-01-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1214

Inclusion Criteria

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

Exclusion Criteria

1. Previous COVID infection before oocyte retrieval
2. Recipient of oocyte donation
3. Undergoing preimplantation genetic testing
4. Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	frozen embryo transfer	Infertile women attending for frozen embryo transfer without a recent past COVID-19 infection
COVID-19 infection group	frozen embryo transfer	Infertile women attending for frozen embryo transfer with a recent past COVID-19 infection

Primary Outcome Measures

Name	Time	Method
live birth rate	a live birth after 22 weeks gestation	live birth rate of the frozen embryo transfer cycle (\>22 weeks of gestation)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ShangHai JIAI Genetics&IVF Institute; 🇨🇳 Shanghai, China