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Status unknownNCT05063942Covid-19Updated Oct 1, 2021

The Effect of Covid-19 Vaccination in Patients Undergoing IVF

An observational study in Covid-19 Vaccination, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown. Open to female participants aged 18 Years to 43 Years. Per ClinicalTrials.gov, last updated 2021-10-01.

Sponsored by Shanghai First Maternity and Infant Hospital · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
712
Ages
18 Years to 43 Years
Sex
Female
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Study 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.

Read the detailed description

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).Although a major victory has been achieved in the fight against the epidemic since first case was reported in Wuhan City,, the cumulative death toll is 5,691 by the end of September in China . At the present time, mitigation strategies for controlling the pandemic continue to rely heavily on universal masking, physical distancing, limiting social interactions, and frequent sanitizing measures. 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. Unlike inactivated vaccines, the mRNA vaccine does not use natural pathogens, but artificially synthesizes the gene sequence encoding a specific antigen protein, and then directly injects the mRNA encoding the antigen protein into the human body to induce the immune system to produce antibodies against the new coronavirus. Although some studies have shown that mRNA vaccines do not increase the risk of miscarriage in women, the conclusion is limited due to the lack of non-pregnant women as a control group. At the same time, the impact of inactivated vaccines on female pregnancy is still in a blank state. Nationwide anti-COVID-19 vaccination began in China in March 2020, using the inactivated vaccine 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. 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.

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Conditions studied

  • Covid-19 Vaccination

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Keywords

  • IVF Covid-19 Vaccination live birth rate
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 712 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 45 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 43 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing IVF with and without COVID- 19 vaccination.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
712 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. live birth rate per transfer

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

    Time frame: 10 month

Secondary outcomes

  1. biochemical pregnancy rate

    positive urine pregnancy test

    Time frame: 2 weeks

  2. clinical pregnancy rate

    presence of intrauterine gestational sac on ultrasound

    Time frame: 4 weeks

  3. embryo implantation rate

    number of gestational sacs per embryo transferred

    Time frame: 2month

  4. number of transferable embryos

    Number of oocytes retrieved and embryos/blastocysts suitable for freezing and transfer

    Time frame: 2weeks

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 32866858 ↗
  • 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. PubMed 33573712 ↗
  • 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. PubMed 32365180 ↗
  • 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. PubMed 33151921 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05063942
Lead sponsor
Shanghai First Maternity and Infant Hospital
Responsible party
chen zhi qin (Professor, Shanghai First Maternity and Infant Hospital) — Principal investigator
First posted
Oct 1, 2021
Start date
Oct 1, 2021 (estimated)
Primary completion
Dec 2022 (estimated)
Completion
Dec 2023 (estimated)
Last update
Oct 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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