Novel Coronavirus Infection and Reproductive Function

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

The Effects and Underlying Mechanisms of Novel Coronavirus Infection on Reproductive Function and Assisted Pregnancy Outcome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 1 year
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.A
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical and laboratory indicators related to male and female reproductive function
Time Frame: 1 year
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
1 year
Outcome indicators of assisted pregnancy
Time Frame: 1 year
Embryo implantation rate, early abortion rate, ongoing pregnancy rate, incidence of OHSS
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Coagulation index
Time Frame: 1 year
D-dimer
1 year
Indicators of susceptibility to COVID-19 infection
Time Frame: 1 year
blood lipid, blood sugar, insulinand thyroid function
1 year
Oxidative stress index
Time Frame: 1 year
fingertip pulse oxygen saturation
1 year
SAS Anxiety Scale
Time Frame: 1 year
SAS Anxiety Scale
1 year

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jinling Hospital, China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 16, 2023

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • COVID-19 and reproduction

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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