Novel Coronavirus Infection and Reproductive Function

NCT05685992 | Unknown DMC

• 1 other identifier: COVID-19 and reproduction
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

This study aims to observe the impact of COVID-19 infection on the reproductive function and assisted pregnancy outcome of infertile couples undergoing assisted reproductive technology and to determine which factors are related to the clinical pregnancy rate. A multicenter, prospective, observational cohort study was adopted. Infertile couples who met the selection criteria were included in this study, the SAS anxiety self-rating scale was filled out, the basic situation was observed, and blood samples and related tissues were collected for testing. Relevant reproductive function, laboratory, clinical, and psychological indicators were collected, and the correlation between the above indicators and the outcome of the ART-related pregnancy were analyzed.

Conditions

COVID-19 Infection

Keywords

COVID-19; Reproductive function; Sustained 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.

  1 year

Secondary Outcomes (2)

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

  1 year

• Outcome indicators of assisted pregnancy

  1 year

Other Outcomes (4)

• Coagulation index

  1 year

• Indicators of susceptibility to COVID-19 infection

  1 year

• Oxidative stress index

  1 year

Study Arms (1)

Infertile couples infected or not infected with COVID-19

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

Other: no intervention

Interventions

no intervention OTHER

no intervention

Infertile couples infected or not infected with COVID-19

Eligibility Criteria

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

You may not qualify if:

• Patients with contraindications to pregnancy or assisted reproductive technology

Sponsors & Collaborators

• Jinling Hospital, China: lead

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: 32179124 BACKGROUND

• 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: 26203058 BACKGROUND

• 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: 32134205 BACKGROUND

• 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: 32192578 BACKGROUND

• 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: 32171193 BACKGROUND

• 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: 32900338 BACKGROUND

• 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: 32291094 BACKGROUND

• 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: 32227120 BACKGROUND

• 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: 32338827 BACKGROUND

• 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: 34418496 BACKGROUND

• 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: 35272846 BACKGROUND

• 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: 33288478 BACKGROUND

• 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: 35523708 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

• 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: 35212741 BACKGROUND

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

025-80864609; yaobing@nju.edu.cn

Li Chen, PHD

CONTACT

025-80864609; 872276095@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 17, 2023
• Study Start: January 20, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (3)