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

NCT05739019 | Completed

• 1 other identifier: JIAI 2023-01
• Study Type: observational
• Target: 820
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19; Frozen Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• live birth rate

  live birth rate of the frozen embryo transfer cycle (\>22 weeks of gestation)

  a live birth after 22 weeks gestation

Secondary Outcomes (10)

• serum hCG level

  a blood pregnancy test is performed 14 days after the embryo transfer

• clinical pregnancy

  presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy

• ongoing pregnancy

  viable pregnancy beyond gestation 12 weeks

• biochemical pregnancy

  positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation

• implantation rate

  number of gestational sacs per embryo transferred during 4 weeks of pregnancy

Study Arms (2)

COVID-19 infection group

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

Other: frozen embryo transfer

Control group

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

Other: frozen embryo transfer

Interventions

frozen embryo transfer OTHER

transfer one or two embryos in frozen embryo transfer cycles

COVID-19 infection group; Control group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Location

Related Publications (6)

• 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.

  PMID: 32246845 BACKGROUND

• 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.

  PMID: 32170560 BACKGROUND

• 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.

  PMID: 19164480 BACKGROUND

• 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.

  PMID: 32641214 BACKGROUND

• 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.

  PMID: 35216833 BACKGROUND

• 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.

  PMID: 35525900 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample is obtained on the day of progesterone supplementation day or luteinizing hormone surge day, and saved for further COVID-19 antibody test.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xiaoxi Sun, PhD

  Shanghai JiAi Genetics & IVF Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: February 22, 2023
• Study Start: February 23, 2023
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)