Clinical trial NCT05685966: Retrospective Study of COVID-19 on Reproductive Function
Official title: Retrospective Study of COVID-19 on Reproductive Function and Assisted Reproductive Technology Pregnancy Outcome in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
Reproductive function
Sustained pregnancy rate
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 3 months
Secondary outcomes:
measure: Clinical and laboratory indicators related to male and female reproductive function
timeFrame: 3 months
measure: Outcome indicators of assisted pregnancy
timeFrame: 3 months
Other outcomes:
measure: Coagulation index
timeFrame: 3 months
measure: Indicators of susceptibility to COVID-19 infection
timeFrame: 3 months
measure: Oxidative stress index
timeFrame: 3 months
measure: SAS Anxiety Scale
timeFrame: 3 months
Locations:
city: Nanjing
country: China
facility: Department for Reproductive Medicine, Jinling Hospital
state: Jiangsu
city: Nantong
country: China
facility: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Department of Reproductive Medicine, Jinling Hospital
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, Xuzhou Maternal and Child Health Care Hospital
name: Xiaojie Huang, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
name: Jiayi Ding, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling 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 Critical Care Medicine, Jinling Hospital
name: Yuxiu Liu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
name: Xiaofang Tan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
name: Yunxia Zhu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Jueraitetibaike Kadiliya, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Reproductive Medicine, Jinling Hospital
name: Zhichan Zou, MD
role: PRINCIPAL_INVESTIGATOR
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