NCT05685966

Brief Summary

This multi-center, retrospective cohort study aimed to determine which factors are associated with ongoing pregnancy rates in infertile patients received ART treatments during the current outbreak of COVID-19 infection.Couples who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07 were included. Patients who were infected with Coronavirus were observation groups; the infection status and clinical outcome were tracked. Patients who were not infected with Coronavirus were control groups.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 17, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 13, 2023

Last Update Submit

January 28, 2023

Conditions

COVID-19

Keywords

COVID-19Reproductive functionSustained pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    If the fetal sac, fetal bud, and primitive fetal heartbeat are found by vaginal B-ultrasound examination 55-65 days after embryo transfer, the diagnosis of ongoing pregnancy will be made.

    3 months

Secondary Outcomes (2)

  • Clinical and laboratory indicators related to male and female reproductive function

    3 months

  • Outcome indicators of assisted pregnancy

    3 months

Other Outcomes (4)

  • Coagulation index

    3 months

  • Indicators of susceptibility to COVID-19 infection

    3 months

  • Oxidative stress index

    3 months

  • +1 more other outcomes

Study Arms (1)

Infertile couples from the research center who visited for fertility disorders

Infertile couples infected or not infected with COVID-19 were included.This is an observational study with no interventions.

Other: no intervention

Interventions

no interventionOTHER

no intervention

Infertile couples from the research center who visited for fertility disorders

Eligibility Criteria

Age20 Years - 42 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Failure to establish a clinical pregnancy after 12 months of regular unprotected intercourse, or due to impaired fertility of the individual or his or her partner, is termed infertility.

You may qualify if:

  • Diagnosed with infertility
  • Patients with IVF-ET/ICSI-ET/FET from 2022/11/23 to 2023/01/07

You may not qualify if:

  • Patients with contraindications to pregnancy or assisted reproductive technology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, China

RECRUITING

Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital

Nantong, Jiangsu, China

RECRUITING

Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

Xuzhou, Jiangsu, China

RECRUITING

Related Publications (15)

  • Rodriguez-Morales AJ, Cardona-Ospina JA, Gutierrez-Ocampo E, Villamizar-Pena R, Holguin-Rivera Y, Escalera-Antezana JP, Alvarado-Arnez LE, Bonilla-Aldana DK, Franco-Paredes C, Henao-Martinez AF, Paniz-Mondolfi A, Lagos-Grisales GJ, Ramirez-Vallejo E, Suarez JA, Zambrano LI, Villamil-Gomez WE, Balbin-Ramon GJ, Rabaan AA, Harapan H, Dhama K, Nishiura H, Kataoka H, Ahmad T, Sah R; Latin American Network of Coronavirus Disease 2019-COVID-19 Research (LANCOVID-19). Electronic address: https://www.lancovid.org. Clinical, laboratory and imaging features of COVID-19: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Mar-Apr;34:101623. doi: 10.1016/j.tmaid.2020.101623. Epub 2020 Mar 13.

    PMID: 32179124BACKGROUND

  • Chu H, Zhou J, Wong BH, Li C, Chan JF, Cheng ZS, Yang D, Wang D, Lee AC, Li C, Yeung ML, Cai JP, Chan IH, Ho WK, To KK, Zheng BJ, Yao Y, Qin C, Yuen KY. Middle East Respiratory Syndrome Coronavirus Efficiently Infects Human Primary T Lymphocytes and Activates the Extrinsic and Intrinsic Apoptosis Pathways. J Infect Dis. 2016 Mar 15;213(6):904-14. doi: 10.1093/infdis/jiv380. Epub 2015 Jul 22.

    PMID: 26203058BACKGROUND

  • Xia W, Shao J, Guo Y, Peng X, Li Z, Hu D. Clinical and CT features in pediatric patients with COVID-19 infection: Different points from adults. Pediatr Pulmonol. 2020 May;55(5):1169-1174. doi: 10.1002/ppul.24718. Epub 2020 Mar 5.

    PMID: 32134205BACKGROUND

  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578BACKGROUND

  • Conti P, Ronconi G, Caraffa A, Gallenga CE, Ross R, Frydas I, Kritas SK. Induction of pro-inflammatory cytokines (IL-1 and IL-6) and lung inflammation by Coronavirus-19 (COVI-19 or SARS-CoV-2): anti-inflammatory strategies. J Biol Regul Homeost Agents. 2020 March-April,;34(2):327-331. doi: 10.23812/CONTI-E.

    PMID: 32171193BACKGROUND

  • Bobrova L, Kozlovskaya N, Korotchaeva Y, Bobkova I, Kamyshova E, Moiseev S. Microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome (MicroCLOTS): a new variant of thrombotic microangiopathy? Crit Care Resusc. 2020 Sep;22(3):284. doi: 10.1016/S1441-2772(23)00399-X. No abstract available.

    PMID: 32900338BACKGROUND

  • Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.

    PMID: 32291094BACKGROUND

  • Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available.

    PMID: 32227120BACKGROUND

  • Thachil J, Tang N, Gando S, Falanga A, Cattaneo M, Levi M, Clark C, Iba T. ISTH interim guidance on recognition and management of coagulopathy in COVID-19. J Thromb Haemost. 2020 May;18(5):1023-1026. doi: 10.1111/jth.14810. Epub 2020 Apr 27. No abstract available.

    PMID: 32338827BACKGROUND

  • Wu M, Ma L, Xue L, Zhu Q, Zhou S, Dai J, Yan W, Zhang J, Wang S. Co-expression of the SARS-CoV-2 entry molecules ACE2 and TMPRSS2 in human ovaries: Identification of cell types and trends with age. Genomics. 2021 Nov;113(6):3449-3460. doi: 10.1016/j.ygeno.2021.08.012. Epub 2021 Aug 18.

    PMID: 34418496BACKGROUND

  • Boudry L, Essahib W, Mateizel I, Van de Velde H, De Geyter D, Pierard D, Waelput W, Uvin V, Tournaye H, De Vos M, De Brucker M. Undetectable viral RNA in follicular fluid, cumulus cells, and endometrial tissue samples in SARS-CoV-2-positive women. Fertil Steril. 2022 Apr;117(4):771-780. doi: 10.1016/j.fertnstert.2021.12.032. Epub 2022 Jan 1.

    PMID: 35272846BACKGROUND

  • Li K, Chen G, Hou H, Liao Q, Chen J, Bai H, Lee S, Wang C, Li H, Cheng L, Ai J. Analysis of sex hormones and menstruation in COVID-19 women of child-bearing age. Reprod Biomed Online. 2021 Jan;42(1):260-267. doi: 10.1016/j.rbmo.2020.09.020. Epub 2020 Sep 29.

    PMID: 33288478BACKGROUND

  • Madendag IC, Madendag Y, Ozdemir AT. COVID-19 disease does not cause ovarian injury in women of reproductive age: an observational before-and-after COVID-19 study. Reprod Biomed Online. 2022 Jul;45(1):153-158. doi: 10.1016/j.rbmo.2022.03.002. Epub 2022 Mar 5.

    PMID: 35523708BACKGROUND

  • 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: 32641214BACKGROUND

  • Youngster M, Avraham S, Yaakov O, Landau Rabbi M, Gat I, Yerushalmi G, Sverdlove R, Baum M, Maman E, Hourvitz A, Kedem A. IVF under COVID-19: treatment outcomes of fresh ART cycles. Hum Reprod. 2022 May 3;37(5):947-953. doi: 10.1093/humrep/deac043.

    PMID: 35212741BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

serum, seminal plasma, sperm, follicular Fluid, granule cells, embryo culture medium, endometrial tissue, villi and decidual tissue if abortion

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bing Yao, PHD

    Department of Reproductive Medicine, Jinling Hospital

    STUDY CHAIR

  • Li Chen, PHD

    Department of Reproductive Medicine, Jinling Hospital

    STUDY DIRECTOR

  • Xiaojie Huang, PHD

    Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Jiayi Ding, PHD

    Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Qin Sun, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Meiling Li, PHD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Cheng Zhou, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Xi Chen, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Yuming Feng, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Juanjuan Xu, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Haiyan Fu, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Cencen Wang, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Hong Zhang, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Lu Zheng, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Yuxiu Liu, PHD

    Department of Critical Care Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaofang Tan, MD

    Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Yunxia Zhu, MD

    Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

    PRINCIPAL INVESTIGATOR

  • Jueraitetibaike Kadiliya, PHD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

  • Zhichan Zou, MD

    Department of Reproductive Medicine, Jinling Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Yao, PHD

CONTACT

025-80864609yaobing@nju.edu.cn

Li Chen, PHD

CONTACT

025-80864609872276095@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2023

First Posted

January 17, 2023

Study Start

January 20, 2023

Primary Completion

March 30, 2023

Study Completion

January 30, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

CN(3)