Impact of COVID-19 on Psychological Status in Case of IVF Interrupted or Postponed

February 4, 2022 updated by: Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Impact of COVID-19 Pandemic on the Psychological Status of Infertile Patients Who Had in Vitro Fertilization Treatment Interrupted or Postponed

Infertility is a severely distressing experience for many couples. Depression and anxiety are psychological disorders associated with infertility, and they may worsen during infertility treatments.

This study times to understand the changes in the psychological status of infertile patients who had in vitro fertilization (IVF) treatment interrupted or postponed because of the COVID-19 pandemic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

503

Contacts and Locations

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

Study Locations

  • Italy
      • Genoa, Italy, 16132
        • IRCCS Ospedale Policlinico San Martino

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with IVF treatment interrupted or delayed during COVID-19 pandemic

Description

Inclusion Criteria:

  • patients with IVF treatment interrupted or delayed during COVID-19 pandemic
  • patients with signed informed consent
  • patients with more than 18 years

Exclusion Criteria:

  • patients with already diagnosed psychiatric disorders

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
Intervention / Treatment
Infertile women who had the IVF treatment postponed or delayed
Behavioral: Generalized Anxiety Disorder-7 (GAD-7)
The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders.
Behavioral: Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of anxiety
Time Frame: 1-4 weeks after communication of interrupted or delayed IVF
1-4 weeks after communication of interrupted or delayed IVF
Severity of depression
Time Frame: 1-4 weeks after communication of interrupted or delayed IVF
1-4 weeks after communication of interrupted or delayed IVF

Collaborators and Investigators

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

Sponsor

Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

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 (Actual)

April 1, 2020

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

May 15, 2020

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 22, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19-NOIVF

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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