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NCT Number: NCT05739019

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

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

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Frozen Embryo Transfer Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Frozen embryo transfer

Other

transfer one or two embryos in frozen embryo transfer cycles

Primary outcomes

  1. 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

  1. serum hCG level

    Time frame: a blood pregnancy test is performed 14 days after the embryo transfer

    serum hCG level

  2. clinical pregnancy

    Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy

    presence of intrauterine gestational sac on ultrasound

  3. ongoing pregnancy

    Time frame: viable pregnancy beyond gestation 12 weeks

    viable pregnancy beyond gestation 12 weeks

  4. biochemical pregnancy

    Time frame: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation

    positive blood pregnancy test not followed by clinical pregnancy

  5. implantation rate

    Time frame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy

    number of gestational sacs per embryo transferred

  6. multiple pregnancy

    Time frame: multiple pregnancy beyond gestation 12 weeks

    more than one intrauterine sacs on scanning

  7. ectopic pregnancy

    Time frame: ectopic pregnancy during 12 weeks gestation

    pregnancy outside the uterine cavity

  8. miscarriage

    Time frame: the loss of a pregnancy before 22 weeks gestation

    the loss of a pregnancy before 22 weeks gestation

  9. birth weight

    Time frame: a live birth after 22 weeks gestation

    birth weight of the baby delivered

  10. serum COVID-19 antibody level

    Time frame: 7 days before embryo transfer

    serum COVID-19 antibody level immunoglobulin G and immunoglobulin M

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 22, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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