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

Sponsor
ShangHai Ji Ai Genetics & IVF Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05739019
Collaborator
(none)
1,214
1
18.2
66.8

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: frozen embryo transfer

Study Design

Study Type:
Observational
Anticipated Enrollment :
1214 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Anticipated Study Start Date :
Feb 25, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
COVID-19 infection group

Infertile women attending for frozen embryo transfer with a recent past COVID-19 infection

Other: frozen embryo transfer
transfer one or two embryos in frozen embryo transfer cycles

Control group

Infertile women attending for frozen embryo transfer without a recent past COVID-19 infection

Other: frozen embryo transfer
transfer one or two embryos in frozen embryo transfer cycles

Outcome Measures

Primary Outcome Measures

  1. 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

  1. serum hCG level [a blood pregnancy test is performed 14 days after the embryo transfer]

    serum hCG level

  2. clinical pregnancy [presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy]

    presence of intrauterine gestational sac on ultrasound

  3. ongoing pregnancy [viable pregnancy beyond gestation 12 weeks]

    viable pregnancy beyond gestation 12 weeks

  4. biochemical pregnancy [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 [number of gestational sacs per embryo transferred during 4 weeks of pregnancy]

    number of gestational sacs per embryo transferred

  6. multiple pregnancy [multiple pregnancy beyond gestation 12 weeks]

    more than one intrauterine sacs on scanning

  7. ectopic pregnancy [ectopic pregnancy during 12 weeks gestation]

    pregnancy outside the uterine cavity

  8. miscarriage [the loss of a pregnancy before 22 weeks gestation]

    the loss of a pregnancy before 22 weeks gestation

  9. birth weight [a live birth after 22 weeks gestation]

    birth weight of the baby delivered

  10. serum COVID-19 antibody level [7 days before embryo transfer]

    serum COVID-19 antibody level immunoglobulin G and immunoglobulin M

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 42 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ShangHai JIAI Genetics&IVF Institute Shanghai China

Sponsors and Collaborators

  • ShangHai Ji Ai Genetics & IVF Institute

Investigators

  • Study Director: Xiaoxi Sun, PhD, Shanghai JiAi Genetics & IVF Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier:
NCT05739019
Other Study ID Numbers:
  • JIAI 2023-01
First Posted:
Feb 22, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023