Retrospective Study of COVID-19 on Reproductive Function

NCT ID: NCT05685966

Last Updated: 2023-01-31

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

2024-01-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

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

025-80864609

Li Chen, PHD

Role: CONTACT

025-80864609

Facility Contacts

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Bing Yao, PHD

Role: primary

86-25-80864609

Jiayi Ding, PHD

Role: primary

0513-85908068

Xiaojie Huang, PHD

Role: primary

0516-83907317

References

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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.

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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.

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Reference Type BACKGROUND
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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.

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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.

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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
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Other Identifiers

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Retrospective study of COVID19

Identifier Type: -

Identifier Source: org_study_id

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