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NCT05739019 Clinical Trial

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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05739019
Other study ID # JIAI 2023-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2023
Est. completion date August 31, 2024

Study information
Verified date April 2024
Source ShangHai Ji Ai Genetics & IVF Institute
Contact He Li, MD
Phone +8613817223099
Email lihe198900@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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

Recruitment information / eligibility
Status Recruiting
Enrollment 1214
Est. completion date August 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 42 Years
Eligibility Inclusion Criteria: 1. Women aged 20-42 years at the time of ovarian stimulation for in vitro fertilization 2. Women have embryos frozen prior to COVID infection. Exclusion Criteria: 1. Previous COVID infection before oocyte retrieval 2. Recipient of oocyte donation 3. Undergoing preimplantation genetic testing 4. Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• frozen embryo transfer
transfer one or two embryos in frozen embryo transfer cycles

Locations
Country Name City State
China ShangHai JIAI Genetics&IVF Institute Shanghai

Sponsors (1)
Lead Sponsor Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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