Beyond Fertility: a psychosocial intervention to promote patients’ healthy adjustment to unsuccessful fertility treatment

Not Applicable

Completed

• Conditions: Fertility health problems; Pregnancy and Childbirth

• Registration Number: ISRCTN85897617
• Lead Sponsor: Cardiff University

Brief Summary

2024 Abstract results in https://doi.org/10.1093/humrep/deae108.126 (added 08/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-14
• Study Completion: 2023-12-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 540

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Mental health measured using the Mental Health Inventory-5 (MHI-5)<br>2. Wellbeing measured using the Satisfaction with Life Scale (SWLS) and the Flourishing Scale (FS)<br><br>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.