NCT06186947

Brief Summary

This is a large observational cohort study to assess the impact of COVID-19 infection on pregnancy outcomes and offspring health.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

December 28, 2023

Last Update Submit

December 28, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • Clinical pregnancy rate

    Clinical pregnancy is defined as the ultrasound confirmation of at least one gestational sac.

    7 weeks after the day of embryo transfer

  • Ongoing pregnancy rate

    Ongoing pregnancy is defined as continued pregnancy beyond 12 weeks of gestation.

    12 weeks after the day of embryo transfer

Secondary Outcomes (3)

  • Live birth rate

    10 months after the day of embryo transfer

  • Pregnancy loss rate

    10 months after the day of embryo transfer

  • Congenital malformation rate

    12 months after the day of embryo transfer

Study Arms (2)

COVID-19 group

Patients infected by SARS CoV2 before reproductive events.

Other: No intervention

Control group

Patients who were not infected by SARS CoV2 before reproductive events.

Other: No intervention

Interventions

No interventionOTHER

Participants are not subjected to any specific intervention.

COVID-19 groupControl group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with reproductive needs are recruited for study.

You may qualify if:

  • Women aged between 18-50 years old.
  • Patients with signed informed consent.
  • Patients with complete COVID-19 infection information.

You may not qualify if:

  • Patients with abnormal karyotype
  • Recipients of oocyte donation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Women, Children and Reproductive Health

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zi-Jiang Chen

    Shandong University

    STUDY CHAIR

Central Study Contacts

Zi-Jiang Chen

CONTACT

+0086 531 85187856chenzijiang@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academician

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 2, 2024

Study Start

September 1, 2022

Primary Completion

March 31, 2024

Study Completion

December 31, 2024

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

CN(1)