COVID-19NCT05739019

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

An observational study of COVID-19 and Frozen Embryo Transfer, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 20 to 42 years, women only
Conditions the study is for: COVID-19, Frozen Embryo Transfer
What is being tested?: frozen embryo transfer
How many people: 820 participants
Where: 1 siteChina
Study dates: 23 Feb 2023to 1 Feb 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 42 years
Women only
No healthy volunteers
Adult

Study population: Infertile women for frozen embryo transfer will be recruited for study after explanation and counseling if they fulfil the inclusion criteria and do not have the exclusion criteria.

Who may be able to join

Women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization
Women have embryos frozen prior to COVID infection.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

ShangHai JIAI Genetics&IVF Institute
Shanghai

Other trials in China

About this study

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

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

Conditions: COVID-19, Frozen Embryo Transfer
Being tested: frozen embryo transfer
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

frozen embryo transferOther
transfer one or two embryos in frozen embryo transfer cycles

Study groups in NCT05739019
Study group	Role	What they receive
COVID-19 infection group		Infertile women attending for frozen embryo transfer with a recent past COVID-19 infection Receives: Other: frozen embryo transfer
Control group		Infertile women attending for frozen embryo transfer without a recent past COVID-19 infection Receives: Other: frozen embryo transfer

What is being measured

The primary outcome is the main question the study is designed to answer.

live birth rate
live birth rate of the frozen embryo transfer cycle (>22 weeks of gestation)
Measured: a live birth after 22 weeks gestation

Secondary outcomes (10)

serum hCG level
serum hCG level
Measured: a blood pregnancy test is performed 14 days after the embryo transfer
clinical pregnancy
presence of intrauterine gestational sac on ultrasound
Measured: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
ongoing pregnancy
viable pregnancy beyond gestation 12 weeks
Measured: viable pregnancy beyond gestation 12 weeks
biochemical pregnancy
positive blood pregnancy test not followed by clinical pregnancy
Measured: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation
implantation rate
number of gestational sacs per embryo transferred
Measured: number of gestational sacs per embryo transferred during 4 weeks of pregnancy
multiple pregnancy
more than one intrauterine sacs on scanning
Measured: multiple pregnancy beyond gestation 12 weeks
ectopic pregnancy
pregnancy outside the uterine cavity
Measured: ectopic pregnancy during 12 weeks gestation
miscarriage
the loss of a pregnancy before 22 weeks gestation
Measured: the loss of a pregnancy before 22 weeks gestation
birth weight
birth weight of the baby delivered
Measured: a live birth after 22 weeks gestation
serum COVID-19 antibody level
serum COVID-19 antibody level immunoglobulin G and immunoglobulin M
Measured: 7 days before embryo transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 20231 Feb 2025

First posted22 Feb 2023
Study start23 Feb 2023
Primary completion1 Jan 2025
Study completion1 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 820 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05739019
Sponsor's protocol ID: JIAI 2023-01
Status last verified: May 2025
First submitted: 21 Feb 2023
Last updated: 28 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication

Publications

Lukassen S, Chua RL, Trefzer T, Kahn NC, Schneider MA, Muley T, Winter H, Meister M, Veith C, Boots AW, Hennig BP, Kreuter M, Conrad C, Eils R. SARS-CoV-2 receptor ACE2 and TMPRSS2 are primarily expressed in bronchial transient secretory cells. EMBO J. 2020 May 18;39(10):e105114. doi: 10.15252/embj.20105114. Epub 2020 Apr 14.
PubMed 32246845
Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.
PubMed 32170560
Vaz-Silva J, Carneiro MM, Ferreira MC, Pinheiro SV, Silva DA, Silva-Filho AL, Witz CA, Reis AM, Santos RA, Reis FM. The vasoactive peptide angiotensin-(1-7), its receptor Mas and the angiotensin-converting enzyme type 2 are expressed in the human endometrium. Reprod Sci. 2009 Mar;16(3):247-56. doi: 10.1177/1933719108327593. Epub 2009 Jan 22.
PubMed 19164480
Henarejos-Castillo I, Sebastian-Leon P, Devesa-Peiro A, Pellicer A, Diaz-Gimeno P. SARS-CoV-2 infection risk assessment in the endometrium: viral infection-related gene expression across the menstrual cycle. Fertil Steril. 2020 Aug;114(2):223-232. doi: 10.1016/j.fertnstert.2020.06.026. Epub 2020 Jun 17.
PubMed 32641214
Aizer A, Noach-Hirsh M, Dratviman-Storobinsky O, Nahum R, Machtinger R, Yung Y, Haas J, Orvieto R. The effect of coronavirus disease 2019 immunity on frozen-thawed embryo transfer cycles outcome. Fertil Steril. 2022 May;117(5):974-979. doi: 10.1016/j.fertnstert.2022.01.009. Epub 2022 Jan 10.
PubMed 35216833
Youngster M, Avraham S, Yaakov O, Landau Rabbi M, Gat I, Yerushalmi G, Baum M, Maman E, Hourvitz A, Kedem A. The impact of past COVID-19 infection on pregnancy rates in frozen embryo transfer cycles. J Assist Reprod Genet. 2022 Jul;39(7):1565-1570. doi: 10.1007/s10815-022-02517-w. Epub 2022 May 7.
PubMed 35525900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05739019
Acronym / sponsor ID: JIAI 2023-01
Conditions: COVID-19, Frozen Embryo Transfer
Study type: Observational
Recruitment status: Completed
Enrolment: 820 participants (actual)
Lead sponsor: ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
Study start: 23 Feb 2023 (actual)
Primary completion: 1 Jan 2025 (actual)
Study completion: 1 Feb 2025 (actual)
First posted: 22 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
COVID-19 infection group	–	Other: frozen embryo transferInfertile women attending for frozen embryo transfer with a recent past COVID-19 infection
Control group	–	Other: frozen embryo transferInfertile women attending for frozen embryo transfer without a recent past COVID-19 infection

Who may qualify

Ages: 20 to 42 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: Infertile women for frozen embryo transfer will be recruited for study after explanation and counseling if they fulfil the inclusion criteria and do not have the exclusion criteria.

Key inclusion criteria (2 listed)

Women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization
Women have embryos frozen prior to COVID infection.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
frozen embryo transfertransfer one or two embryos in frozen embryo transfer cycles	Other	COVID-19 infection group, Control group

Primary outcome

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)

10 secondary outcomes

serum hCG level
Time frame: a blood pregnancy test is performed 14 days after the embryo transfer
clinical pregnancy
Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
ongoing pregnancy
Time frame: viable pregnancy beyond gestation 12 weeks
biochemical pregnancy
Time frame: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation
implantation rate
Time frame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy
multiple pregnancy
Time frame: multiple pregnancy beyond gestation 12 weeks
ectopic pregnancy
Time frame: ectopic pregnancy during 12 weeks gestation
miscarriage
Time frame: the loss of a pregnancy before 22 weeks gestation
birth weight
Time frame: a live birth after 22 weeks gestation
serum COVID-19 antibody level
Time frame: 7 days before embryo transfer

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Background: PubMed 32246845Lukassen S, Chua RL, Trefzer T, Kahn NC, Schneider MA, Muley T, Winter H, Meister M, Veith C, Boots AW, Hennig BP, Kreuter M, Conrad C, Eils R. SARS-CoV-2 receptor ACE2 and TMPRSS2 are primarily expressed in bronchial transient secretory cells. EMBO J. 2020 May 18;39(10):e105114. doi: 10.15252/embj.20105114. Epub 2020 Apr 14.
Background: PubMed 32170560Zou X, Chen K, Zou J, Han P, Hao J, Han Z. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Apr;14(2):185-192. doi: 10.1007/s11684-020-0754-0. Epub 2020 Mar 12.
Background: PubMed 19164480Vaz-Silva J, Carneiro MM, Ferreira MC, Pinheiro SV, Silva DA, Silva-Filho AL, Witz CA, Reis AM, Santos RA, Reis FM. The vasoactive peptide angiotensin-(1-7), its receptor Mas and the angiotensin-converting enzyme type 2 are expressed in the human endometrium. Reprod Sci. 2009 Mar;16(3):247-56. doi: 10.1177/1933719108327593. Epub 2009 Jan 22.
Background: PubMed 32641214Henarejos-Castillo I, Sebastian-Leon P, Devesa-Peiro A, Pellicer A, Diaz-Gimeno P. SARS-CoV-2 infection risk assessment in the endometrium: viral infection-related gene expression across the menstrual cycle. Fertil Steril. 2020 Aug;114(2):223-232. doi: 10.1016/j.fertnstert.2020.06.026. Epub 2020 Jun 17.
Background: PubMed 35216833Aizer A, Noach-Hirsh M, Dratviman-Storobinsky O, Nahum R, Machtinger R, Yung Y, Haas J, Orvieto R. The effect of coronavirus disease 2019 immunity on frozen-thawed embryo transfer cycles outcome. Fertil Steril. 2022 May;117(5):974-979. doi: 10.1016/j.fertnstert.2022.01.009. Epub 2022 Jan 10.
Background: PubMed 35525900Youngster M, Avraham S, Yaakov O, Landau Rabbi M, Gat I, Yerushalmi G, Baum M, Maman E, Hourvitz A, Kedem A. The impact of past COVID-19 infection on pregnancy rates in frozen embryo transfer cycles. J Assist Reprod Genet. 2022 Jul;39(7):1565-1570. doi: 10.1007/s10815-022-02517-w. Epub 2022 May 7.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoxi Sun, PhD study director

Shanghai JiAi Genetics & IVF Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Frozen Embryo Transfer, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

live birth rate (time frame: a live birth after 22 weeks gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05739019, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.