- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04396210
Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Ghent, Belgium, 9000
- Ghent University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Frauke Vanden Meerschaut, MD, University Hospital, Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B6702020000247
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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