Novel Coronavirus Infection and Reproductive Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2024-01-31

Brief Summary

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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.

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Detailed Description

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In this multicenter, prospective, observational cohort study, we included infertile couples based on inclusion criteria. The couples were asked to fill in the SAS anxiety self-rating scale. Basic information about patients' vaccination status, symptoms related to viral infection, menstruation, sexual desire, and sexual function were obtained. Blood samples of couples were collected on the date of diagnosis, the start date of the fresh cycle during assisted reproductive technology treatment, the day of oocyte retrieval, the day of embryo transfer, the day of 14 days, 35 days after embryo transfer, and the day of 70 days of gestation. Follicular fluid, granulosa cells on the day of oocyte retrieval, and embryo culture fluid on the day of embryo transfer were collected. Blood samples and endometrial tissues were collected five days after oocyte retrieval. Blood samples from the menstrual period, endometrial transformation day, and embryo transfer day of the frozen embryo transfer cycle were also collected. Then C-reactive protein, erythrocyte sedimentation rate, procalcitonin and IL-6, granulocyte-macrophage colony-stimulating factor (GM-CSF), TNF-α, VEGF, and other cytokines and chemokines were determined. In addition, fasting blood glucose, insulin, blood lipids, alpha-function, renin-angiotensinase, I-aldosterone, and other susceptibility indicators to COVID-19 infection were tested. Oxygen saturation, malondialdehyde (MDA), HO-1, and SOD oxidative stress indices of the fingertip pulse were determined. An endometrial receptivity gene chip and proteomics detected endometrial tissue. A panel kit for blood vessel and inflammation indicators detected the abortion decidua tissue. 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 collected. Assisted pregnancy outcome: clinical pregnancy rate, embryo implantation rate, early abortion rate, ongoing pregnancy rate, and other clinical indicators, as well as psychological indicators such as the SAS anxiety scale, were analyzed to determine the correlation between the above indicators and ART-related pregnancy outcome.

Conditions

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COVID-19 Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with infertility

Exclusion Criteria

* Patients with contraindications to pregnancy or assisted reproductive technology

Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Bing Yao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bing Yao, PHD

Role: STUDY_CHAIR

Department of Reproductive Medicine, Jinling Hospital

Li Chen, PHD

Role: STUDY_DIRECTOR

Department of Reproductive Medicine, Jinling Hospital

Xiaojie Huang, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Jiayi Ding, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Qin Sun, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Meiling Li, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Cheng Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Xi Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Yuming Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Juanjuan Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Haiyan Fu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Cencen Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Hong Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Lu Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Yuxiu Liu, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine, Jinling Hospital

Xiaofang Tan, MD

Role: PRINCIPAL_INVESTIGATOR

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

Yunxia Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Jueraitetibaike Kadiliya, PHD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Zhichan Zou, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Reproductive Medicine, Jinling Hospital

Locations

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Department for Reproductive Medicine, Jinling Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

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

Nantong, Jiangsu, China

Site Status RECRUITING

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

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bing Yao, PHD

Role: CONTACT

[email protected]

025-80864609

Li Chen, PHD

Role: CONTACT

[email protected]

025-80864609

Facility Contacts

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Bing Yao, PHD

Role: primary

[email protected]

86-25-80864609

Jiayi Ding, PHD

Role: primary

[email protected]

0513-85908068

Xiaojie Huang, PHD

Role: primary

[email protected]

0516-83907317

References

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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.

Reference Type BACKGROUND

PMID: 32179124 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 26203058 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32134205 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32192578 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32171193 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32900338 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32291094 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32227120 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32338827 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 34418496 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 35272846 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 33288478 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 35523708 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 32641214 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 35212741 (View on PubMed)

Other Identifiers

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COVID-19 and reproduction

Identifier Type: -

Identifier Source: org_study_id

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Novel Coronavirus Infection and Reproductive Function

Study Results

Basic Information

Brief Summary

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Detailed Description

Conditions

Study Design

Study Groups

Infertile couples infected or not infected with COVID-19

no intervention

Interventions

no intervention

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Jinling Hospital, China

Responsible Party

Bing Yao

Principal Investigators

Bing Yao, PHD

Li Chen, PHD

Xiaojie Huang, PHD

Jiayi Ding, PHD

Qin Sun, MD

Meiling Li, PHD

Cheng Zhou, MD

Xi Chen, MD

Yuming Feng, MD

Juanjuan Xu, MD

Haiyan Fu, MD

Cencen Wang, MD

Hong Zhang, MD

Lu Zheng, MD

Yuxiu Liu, PHD

Xiaofang Tan, MD

Yunxia Zhu, MD

Jueraitetibaike Kadiliya, PHD

Zhichan Zou, MD

Locations

Department for Reproductive Medicine, Jinling Hospital

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

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

Countries

Central Contacts

Bing Yao, PHD

Li Chen, PHD

Facility Contacts

Bing Yao, PHD

Jiayi Ding, PHD

Xiaojie Huang, PHD

References

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.

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.

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.

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.

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.

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.

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.

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.

Other Identifiers

COVID-19 and reproduction

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