NCT05063942

Brief Summary

Since emerging in the last months of 2019, over 127 000 000 individuals have suffered severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection, and the documented death toll from coronavirus disease 2019 (COVID-19) had reached 2788639 individuals globally by the end of March 2021 (CDC, 2021).It is hoped that widespread vaccination will further limit viral spread and shorten the length of the pandemic and its impact on morbidity and mortality. There are currently two vaccines against the new coronavirus: inactivated vaccines and mRNA vaccines.Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine. By the end of September 2021, 2206.054 million doses (including the first and second doses of the vaccine) of the vaccines have been fulfilled.There is still a lack of real-world data to assist clinicians in counseling their IVF patients regarding the possible impact of recent recovery from COVID infection, or vaccination against it, on the potential for success of ART. We aimed to determine the impact of confirmed COVID-19 immunization on IVF outcomes, by comparing live birth rate of the first transfer cycle in patients undergoing IVF with and without COVID- 19 vaccination.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
712

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

1.2 years

First QC Date

September 30, 2021

Last Update Submit

September 30, 2021

Conditions

Covid-19 Vaccination

Keywords

IVF Covid-19 Vaccination live birth rate

Outcome Measures

Primary Outcomes (1)

  • live birth rate per transfer

    A baby born alive after 22 weeks gestation was classified as a live birth

    10 month

Secondary Outcomes (4)

  • biochemical pregnancy rate

    2 weeks

  • clinical pregnancy rate

    4 weeks

  • embryo implantation rate

    2month

  • number of transferable embryos

    2weeks

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing IVF with and without COVID- 19 vaccination.

You may qualify if:

  • Age of women \<43 years at the time of ovarian stimulation for IVF

You may not qualify if:

  • an abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy,
  • moderate or severe endometriosis,
  • Recipient of oocyte donation and
  • Undergoing preimplantation genetic testing
  • Presence of hydrosalpinx or endometrial polyp which is not surgically treated
  • patients with poor ovarian response (less than 3 mature follicles)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Esposito V, Rania E, Lico D, Pedri S, Fiorenza A, Strati MF, Conforti A, Marrone V, Carosso A, Revelli A, Zullo F, Di Carlo C, Venturella R. Influence of COVID-19 pandemic on the psychological status of infertile couples. Eur J Obstet Gynecol Reprod Biol. 2020 Oct;253:148-153. doi: 10.1016/j.ejogrb.2020.08.025. Epub 2020 Aug 23.

    PMID: 32866858RESULT

  • Abu Jabal K, Ben-Amram H, Beiruti K, Batheesh Y, Sussan C, Zarka S, Edelstein M. Impact of age, ethnicity, sex and prior infection status on immunogenicity following a single dose of the BNT162b2 mRNA COVID-19 vaccine: real-world evidence from healthcare workers, Israel, December 2020 to January 2021. Euro Surveill. 2021 Feb;26(6):2100096. doi: 10.2807/1560-7917.ES.2021.26.6.2100096.

    PMID: 33573712RESULT

  • Jing Y, Run-Qian L, Hao-Ran W, Hao-Ran C, Ya-Bin L, Yang G, Fei C. Potential influence of COVID-19/ACE2 on the female reproductive system. Mol Hum Reprod. 2020 Jun 1;26(6):367-373. doi: 10.1093/molehr/gaaa030.

    PMID: 32365180RESULT

  • Zambrano LD, Ellington S, Strid P, Galang RR, Oduyebo T, Tong VT, Woodworth KR, Nahabedian JF 3rd, Azziz-Baumgartner E, Gilboa SM, Meaney-Delman D; CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1641-1647. doi: 10.15585/mmwr.mm6944e3.

    PMID: 33151921RESULT

Related Links

Study Design

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

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 1, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share