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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

18 year–47 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. 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

  2. Patients reproductive behaviour by using a questionnaire

    Time frame: During the COVID-19 pandemic, from March 2020 till June 2020

  3. Patients views on resuming fertility treatment by using a questionnaire

    Time frame: During the COVID-19 pandemic, from March 2020 till June 2020

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 20, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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