Retrospective Study of COVID-19 on Reproductive Function

January 13, 2023 updated by: Bing Yao, Jinling Hospital, China

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Department for Reproductive Medicine, Jinling Hospital
      • Nantong, Jiangsu, China
        • Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
      • Xuzhou, Jiangsu, China
        • Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and laboratory indicators related to male and female reproductive function
Time Frame: 3 months
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
Outcome indicators of assisted pregnancy
Time Frame: 3 months
Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coagulation index
Time Frame: 3 months
D-dimer
3 months
Indicators of susceptibility to COVID-19 infection
Time Frame: 3 months
blood lipid, blood sugar, insulinand thyroid function
3 months
Oxidative stress index
Time Frame: 3 months
fingertip pulse oxygen saturation
3 months
SAS Anxiety Scale
Time Frame: 3 months
SAS Anxiety Scale
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinling Hospital, China

Investigators

  • Study Chair: Bing Yao, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Study Director: Li Chen, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xiaojie Huang, PHD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jiayi Ding, PHD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Qin Sun, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Meiling Li, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cheng Zhou, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Xi Chen, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuming Feng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Juanjuan Xu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Haiyan Fu, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Cencen Wang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Hong Zhang, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Lu Zheng, MD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Yuxiu Liu, PHD, Department of Critical Care Medicine, Jinling Hospital
  • Principal Investigator: Xiaofang Tan, MD, Department of Reproductive Medicine, Nantong Maternal and Child Health Care Hospital
  • Principal Investigator: Yunxia Zhu, MD, Department of Reproductive Medicine, Xuzhou Maternal and Child Health Care Hospital
  • Principal Investigator: Jueraitetibaike Kadiliya, PHD, Department of Reproductive Medicine, Jinling Hospital
  • Principal Investigator: Zhichan Zou, MD, Department of Reproductive Medicine, Jinling Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 20, 2023

Primary Completion (Anticipated)

March 30, 2023

Study Completion (Anticipated)

January 30, 2024

Study Registration Dates

First Submitted

January 13, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Estimate)

January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Retrospective study of COVID19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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