CoronavirusNCT04396210
Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic
An observational study of Coronavirus and COVID, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 47 years
- Conditions the study is for
- Coronavirus, COVID, ART
- What is being tested?
- Questionnaire
- How many people
- 389 participants
- Where
- 1 siteBelgium
- Study dates
- 14 May 2020to 18 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 47 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients whose fertility treatment was discontinued abruptly due to the COVID-19 pandemic
Who may be able to join
- 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).
Who cannot join
- Language other than Dutch
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Coronavirus, COVID, ART, Fertility Issues
- Being tested
- Questionnaire
- Medical subject headings
- Coronavirus Infections, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients perspectives on the abruptly discontinuation of their fertility treatment by using a questionnaire
Measured: During the COVID-19 pandemic, from March 2020 till June 2020
Patients reproductive behaviour by using a questionnaire
Measured: During the COVID-19 pandemic, from March 2020 till June 2020
Patients views on resuming fertility treatment by using a questionnaire
Measured: During the COVID-19 pandemic, from March 2020 till June 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start14 May 2020
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frauke Vanden Meerschaut, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396210
- Sponsor's protocol ID
- B6702020000247
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Perspectives on Discontinuation of Their Fertility Treatment Due to the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04396210
- Acronym / sponsor ID
- B6702020000247
- Conditions
- Coronavirus, COVID, ART, Fertility Issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 20 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients whose fertility treatment was discontinued abruptly due to the COVID-19 pandemic
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Language other than Dutch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireEligible 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. | Other | – |
Primary outcome
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
Patients reproductive behaviour by using a questionnaire
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frauke Vanden Meerschaut, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and COVID, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.