Clinical trial NCT05739019: The Impact of Past Coronavirus Disease 19 (COVID-19) Infection on the Live Birth Rates of Frozen Embryo Transfer Cycles
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Frozen Embryo Transfer
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 820
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: live birth rate
timeFrame: a live birth after 22 weeks gestation
Secondary outcomes:
measure: serum hCG level
timeFrame: a blood pregnancy test is performed 14 days after the embryo transfer
measure: clinical pregnancy
timeFrame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
measure: ongoing pregnancy
timeFrame: viable pregnancy beyond gestation 12 weeks
measure: biochemical pregnancy
timeFrame: positive blood pregnancy test not followed by clinical pregnancy during 12 weeks gestation
measure: implantation rate
timeFrame: number of gestational sacs per embryo transferred during 4 weeks of pregnancy
measure: multiple pregnancy
timeFrame: multiple pregnancy beyond gestation 12 weeks
measure: ectopic pregnancy
timeFrame: ectopic pregnancy during 12 weeks gestation
measure: miscarriage
timeFrame: the loss of a pregnancy before 22 weeks gestation
measure: birth weight
timeFrame: a live birth after 22 weeks gestation
measure: serum COVID-19 antibody level
timeFrame: 7 days before embryo transfer
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShangHai JIAI Genetics&IVF Institute
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: Xiaoxi Sun, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
citation: 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.
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.