Fertility health problems Pregnancy and Childbirth
Conditions
Interventions
Patients who meet the eligibility criteria, consent to participate and complete the baseline assessment (i.e., an online survey via the Qualtrics platform (Qualtrics, Provo Utah, USA) targeting sociod
care as usual (1:1 ratio). For allocation of the participants, a computer-generated sequence of random numbers is used. The randomisation sequence is stratified by centre (i.e., fertility clinic) and
with children) with permuted random block sizes. A minimum sample size of 15 participants per group is required in the analysis of the primary outcome, with a two-sided 5% significance level and a pow
comprehensive guidance informed by an in-depth systematic review on how people adjust to unmet parenthood goals) and applies contextual cognitive behavioural (CCBT) therapeutic principles. Beyond Fert
Sponsors
Cardiff University
Institute of Public Health of the University of Porto (ISPUP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults (aged 18 years or older) 2. Scheduled to initiate, within 1 month, the last IVF/ICSI treatment cycle reimbursed by the NHS (including the last transfer, with own [fresh or cryopreserved] or donated gametes/embryos and with or without preimplantation genetic testing [PGT])
Exclusion criteria
Exclusion criteria: 1. Having been diagnosed with a mental health problem in the last two years (e.g., bipolar disorder, schizophrenia, and other psychoses or dementia) - self-reported 2. Currently receiving therapy (psychotherapy or medication) for a clinically diagnosed mental-health problem - self-reported 3. Currently under psychological treatment by a certified psychologist or therapist, either in an individual or group format, specifically in relation to fertility issues and/or fertility treatment - self-reported 4. Unable to read and speak Portuguese - self-reported
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life measured using the core module of the Fertility Quality of Life at the four assessment time points: (1) baseline - within 1 month before the patients' scheduled date to initiate the last IVF/ICSI treatment cycle reimbursed by the NHS; (2) 2 weeks (3) 3 months, and (4) 6 months post the end of this treatment cycle. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mental health measured using the Mental Health Inventory-5 (MHI-5) 2. Wellbeing measured using the Satisfaction with Life Scale (SWLS) and the Flourishing Scale (FS) These outcomes are measured at (1) baseline - within 1 month before the patients' scheduled date to initiate the last IVF/ICSI treatment cycle reimbursed by the NHS; (2) 2 weeks (3) 3 months, and (4) 6 months post the end of this treatment cycle. | — |
Countries
Portugal
Contacts
Public ContactMariana Sousa Leite
Outcome results
None listed