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

NCT04396210 | Completed

• 1 other identifier: B6702020000247
• Study Type: observational
• Target: 389
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronavirus; COVID; ART; Fertility Issues

Outcome Measures

Primary Outcomes (3)

• 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

• Patients reproductive behaviour by using a questionnaire

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

• Patients views on resuming fertility treatment by using a questionnaire

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• Language other than Dutch

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Coronavirus Infections; Infertility

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Frauke Vanden Meerschaut, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 20, 2020
• Study Start: May 14, 2020
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)