COVID-19 Clinical Trial
Official title:
Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | January 30, 2024 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 42 Years |
Eligibility | Inclusion Criteria: - Diagnosed with infertility - Patients with IVF-ET/ICSI-ET/FET from 2022/11/23 to 2023/01/07 Exclusion Criteria: - Patients with contraindications to pregnancy or assisted reproductive technology |
Country | Name | City | State |
---|---|---|---|
China | Department for Reproductive Medicine, Jinling Hospital | Nanjing | Jiangsu |
China | Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital | Nantong | Jiangsu |
China | Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital | Xuzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jinling Hospital, China |
China,
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. No abstract available. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — 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
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Coagulation index | D-dimer | 3 months | |
Other | Indicators of susceptibility to COVID-19 infection | blood lipid, blood sugar, insulinand thyroid function | 3 months | |
Other | Oxidative stress index | fingertip pulse oxygen saturation | 3 months | |
Other | SAS Anxiety Scale | SAS Anxiety Scale | 3 months | |
Primary | 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 | Clinical and laboratory indicators related to male and female reproductive function | AMH, INB, sex hormone, follicle output rate, Gn days, total Gn, endometrial thickness on the embryo transfer day, semen quality; Oocyte maturation rate, fertilization rate, high-level embryo rate, blastocyst formation rate | 3 months | |
Secondary | Outcome indicators of assisted pregnancy | Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS | 3 months |
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