Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 8:59 PM
Study NCT ID:
NCT05685966
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2023-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of COVID-19 on Reproductive Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, seminal plasma, sperm, follicular Fluid, granule cells, embryo culture medium, endometrial tissue, villi and decidual tissue if abortion'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-28', 'studyFirstSubmitDate': '2023-01-13', 'studyFirstSubmitQcDate': '2023-01-13', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Coagulation index', 'timeFrame': '3 months', 'description': 'D-dimer'}, {'measure': 'Indicators of susceptibility to COVID-19 infection', 'timeFrame': '3 months', 'description': 'blood lipid, blood sugar, insulinand thyroid function'}, {'measure': 'Oxidative stress index', 'timeFrame': '3 months', 'description': 'fingertip pulse oxygen saturation'}, {'measure': 'SAS Anxiety Scale', 'timeFrame': '3 months', 'description': 'SAS Anxiety Scale'}], 'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Clinical and laboratory indicators related to male and female reproductive function', 'timeFrame': '3 months', 'description': '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'}, {'measure': 'Outcome indicators of assisted pregnancy', 'timeFrame': '3 months', 'description': 'Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Reproductive function', 'Sustained pregnancy rate'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '32179124', 'type': 'BACKGROUND', '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.'}, {'pmid': '26203058', 'type': 'BACKGROUND', '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.'}, {'pmid': '32134205', 'type': 'BACKGROUND', '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.'}, {'pmid': '32192578', 'type': 'BACKGROUND', '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.'}, {'pmid': '32171193', 'type': 'BACKGROUND', '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.'}, {'pmid': '32900338', 'type': 'BACKGROUND', 'citation': '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': '32291094', 'type': 'BACKGROUND', '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.'}, {'pmid': '32227120', 'type': 'BACKGROUND', '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.'}, {'pmid': '32338827', 'type': 'BACKGROUND', '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.'}, {'pmid': '34418496', 'type': 'BACKGROUND', '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.'}, {'pmid': '35272846', 'type': 'BACKGROUND', '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.'}, {'pmid': '33288478', 'type': 'BACKGROUND', '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.'}, {'pmid': '35523708', 'type': 'BACKGROUND', '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.'}, {'pmid': '32641214', 'type': 'BACKGROUND', '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.'}, {'pmid': '35212741', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "In this multi-center, retrospective cohort study, we included patients who underwent IVF-ET/ICSI-ET/FET due to infertility in the department of Reproductive Medicine from 2022-11-23 to 2023-01-07. 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. We compared different parameters between two groups. The primary outcome was ongoing pregnancy rate. Basic information about patients' menstruation, sexual desire, and sexual function were collected from Medical record system. Other information about patients' vaccination status, symptoms related to viral infection were collected by telephone follow ups. Susceptibility indicators to COVID-19 infection including fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone were obtained . Reproductive function indices AMH, INHB, sex hormones, follicle retrieval rate, Gn days, total Gn, endometrial thickness, the incidence of OHSS, semen quality, oocyte maturation rate, fertilization rate, qualified embryo rate, blastocyst formation rate, and other laboratory indices of both men and women were also collected . Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators were analyzed to determine whether there is deference in clinical outcomes between two groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with infertility\n* Patients with IVF-ET/ICSI-ET/FET from 2022/11/23 to 2023/01/07\n\nExclusion Criteria:\n\n* Patients with contraindications to pregnancy or assisted reproductive technology'}, 'identificationModule': {'nctId': 'NCT05685966', 'briefTitle': 'Retrospective Study of COVID-19 on Reproductive Function', 'organization': {'class': 'OTHER', 'fullName': 'Jinling Hospital, China'}, 'officialTitle': 'Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China', 'orgStudyIdInfo': {'id': 'Retrospective study of COVID19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile couples from the research center who visited for fertility disorders', 'description': 'Infertile couples infected or not infected with COVID-19 were included.This is an observational study with no interventions.', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention', 'armGroupLabels': ['Infertile couples from the research center who visited for fertility disorders']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bing Yao, PHD', 'role': 'CONTACT', 'email': 'yaobing@nju.edu.cn', 'phone': '86-25-80864609'}], 'facility': 'Department for Reproductive Medicine, Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nantong', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiayi Ding, PHD', 'role': 'CONTACT', 'email': 'djy916@126.com', 'phone': '0513-85908068'}], 'facility': 'Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Xuzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaojie Huang, PHD', 'role': 'CONTACT', 'email': 'huangxj1959@126.com', 'phone': '0516-83907317'}], 'facility': 'Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital', 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}], 'centralContacts': [{'name': 'Bing Yao, PHD', 'role': 'CONTACT', 'email': 'yaobing@nju.edu.cn', 'phone': '025-80864609'}, {'name': 'Li Chen, PHD', 'role': 'CONTACT', 'email': '872276095@qq.com', 'phone': '025-80864609'}], 'overallOfficials': [{'name': 'Bing Yao, PHD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Li Chen, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Xiaojie Huang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital'}, {'name': 'Jiayi Ding, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital'}, {'name': 'Qin Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Meiling Li, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Cheng Zhou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Xi Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Yuming Feng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Juanjuan Xu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Haiyan Fu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Cencen Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Hong Zhang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Lu Zheng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Yuxiu Liu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Critical Care Medicine, Jinling Hospital'}, {'name': 'Xiaofang Tan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital'}, {'name': 'Yunxia Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital'}, {'name': 'Jueraitetibaike Kadiliya, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}, {'name': 'Zhichan Zou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Reproductive Medicine, Jinling Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinling Hospital, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bing Yao', 'investigatorAffiliation': 'Jinling Hospital, China'}}}}