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

COVID Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396210
• Other study ID #: B6702020000247
• Status: Completed
• Start date: May 14, 2020
• Est. completion date: June 18, 2020

Study information

• Verified date: May 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• ART
• Coronavirus
• COVID
• Fertility Issues
• Infertility

Intervention

Other:
• Questionnaire
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.

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients perspectives on the abruptly discontinuation of their fertility treatment by using a questionnaire		During the COVID-19 pandemic, from March 2020 till June 2020
Primary	Patients reproductive behaviour by using a questionnaire		During the COVID-19 pandemic, from March 2020 till June 2020
Primary	Patients views on resuming fertility treatment by using a questionnaire		During the COVID-19 pandemic, from March 2020 till June 2020