Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic

November 17, 2020 updated by: University Hospital, Ghent

The COVID-19 pandemic brought new challenges to our nationwide healthcare system, with rapid escalation of the number of affected individuals over a handful of weeks. From March 13, a first set of measures was taken to minimise the spread of the virus, which largely impacted societal and economical daily life. A view days later, on March 17, the country was put in "lockdown" and all non-urgent medical treatments were cancelled or postponed. As recommended by the major scientific fertility societies, all non-ivf fertility treatments were discontinued abruptly, whereas started ivf stimulations were continued until oocyte aspiration, where after a freeze-all strategy was applied.

There is little information available for women aiming for pregnancy or embarking on assisted conception. Given the modelling of the pandemic, including the time to peak and subsequent tail, considerable delays in conception to substantially attenuate risk may be required, which will inevitably impact patients wellbeing and overall success rates.

A questionnaire was developed to explore patients perspectives on different aspects of their fertility treatment during the COVID-19 pandemic.

The questionnaire contains the following sections:

  • demographic variables;
  • questions regarding the fertility history of the respondent;
  • questions regarding the impact of fertility treatment cancellation / postponing fertility treatment during COVID-19 on their life, psychological wellbeing and relationship;
  • questions regarding continuing medical treatment on their own, or seeking treatment elsewhere;
  • questions regarding the satisfaction of measures taken by their fertility center regarding the COVID-19 pandemic;
  • questions regarding expectations of further treatments, with focus on safety issues related to the COVID-19 pandemic.

Eligible patients will be selected electronically from our database and digital agenda. After selection, patients will be contacted via email to participate. Two reminders will be send in case the questionnaire is not filled out: a first reminder after one week, a second reminder after two weeks.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

389

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

      • Ghent, Belgium, 9000
        • Ghent University 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

18 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients whose fertility treatment was discontinued abruptly due to the COVID-19 pandemic

Description

Inclusion Criteria:

  • patients that did not start a fertility treatment yet ("intake group") OR;
  • patients for which a treatment plan was made, but treatment was postponed ("before treatment") OR;
  • patients who were undergoing a non-inf treatment cycle (ovulation-induction (OI), intra-uterine insemination (IUI)) and whose cycle was cancelled after starting the treatment cycle ("non-ivf treatment group") OR;
  • patients who were undergoing a cryo cycle and whose cycle was cancelled after starting the treatment cycle ("cryo treatment group") OR;
  • patients who were undergoing an IVF treatment cycle and for whom fresh embryo transfer was cancelled (freeze-all group).

Exclusion Criteria:

  • Language other than Dutch

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patients perspectives on the abruptly discontinuation of their fertility treatment by using a questionnaire
Time Frame: During the COVID-19 pandemic, from March 2020 till June 2020
During the COVID-19 pandemic, from March 2020 till June 2020
Patients reproductive behaviour by using a questionnaire
Time Frame: During the COVID-19 pandemic, from March 2020 till June 2020
During the COVID-19 pandemic, from March 2020 till June 2020
Patients views on resuming fertility treatment by using a questionnaire
Time Frame: During the COVID-19 pandemic, from March 2020 till June 2020
During the COVID-19 pandemic, from March 2020 till June 2020

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Frauke Vanden Meerschaut, MD, University Hospital, Ghent

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)

May 14, 2020

Primary Completion (Actual)

June 18, 2020

Study Completion (Actual)

June 18, 2020

Study Registration Dates

First Submitted

May 18, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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