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

ISRCTN	ISRCTN85897617
DOI	https://doi.org/10.1186/ISRCTN85897617

Submission date: 08/04/2022
Registration date: 14/04/2022
Last edited: 08/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
Around four in every ten patients end fertility treatment without achieving a pregnancy. Facing unsuccessful fertility treatment (i.e., all in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) cycles attempts are unsuccessful, and no new cycles are attempted) triggers an intense and protracted period of grief. European fertility guidelines (European Society of Human Reproduction and Embryology [ESHRE]) stress the need to support patients adjusting to this experience to ameliorate extreme psychosocial reactions and facilitate long-term healthy adjustment. However, there is a scarcity of evaluated interventions available to this end and a lack of provided support during this period. This study aims to evaluate whether a brief psychosocial intervention - Beyond Fertility - supports patients to healthy adjust to this experience.

Who can participate?
Fertility patients aged 18 years or older scheduled to initiate, within 1 month, their last IVF/ICSI treatment cycle reimbursed by the NHS

What does the study involve?
Participants complete an online survey and are randomly assigned to one of two groups: the intervention group or the care as usual group. Participants in the intervention group receive Beyond Fertility. Beyond Fertility is a brief face-to-face psychosocial intervention, designed to support patients adjusting to unsuccessful fertility treatment. It aims to be delivered by a mental healthcare professional, in-person or in an online format via Zoom. Beyond Fertility encompasses seven therapeutic sessions. One first session (in an individual/couple format) to be delivered within 1 month before the patient’s scheduled date to start the last IVF/ICSI treatment cycle reimbursed by the NHS; and six following sessions (one individual/couple and five group sessions) starting 3 weeks after the end of this last IVF/ICSI treatment cycle reimbursed by the NHS. These latter sessions are only directed to those patients who experience an unsuccessful cycle and are not offered or do not plan to undergo an additional cycle. The care as usual group receives the mental healthcare currently offered in the clinics. All patients enrolled in the study (regardless of the treatment cycle outcome) are asked to complete four online surveys over time, i.e., within 1 month before the patient’s scheduled date to initiate the last IVF/ICSI treatment cycle reimbursed by the NHS, and 2 weeks, 3 months, and 6 months after the end of this treatment cycle.

What are the possible benefits and risks of participating?
This intervention aims to promote patients’ healthy adjustment to unsuccessful fertility treatment. Although the control group does not receive the intervention and only the usual care, research has shown that, in general, people appreciate participating in research studies and evaluate this experience as beneficial and positive for their wellbeing. At the end of the study, a debrief will be sent to all the participants, and the possibility of being referred to individualised psychological support and other forms of support will also be offered. Patients who do not meet the inclusion criteria to participate, do not consent, or withdraw from the trial will also be offered this possibility.
As with any intervention in the field of psychology, during the therapeutic process, patients are expected to experience negative emotions and thoughts, which can be distressing. However, this process will be carried out in a controlled context, led by a trained clinical psychologist. Notwithstanding, those patients who experience significant discomfort, which is not manageable in the context of Beyond Fertility, will be referred to individualised psychological support and other forms of support.

Where is the study run from?
1. Cardiff University (UK)
2. Institute of Public Health of the University of Porto (ISPUP) (Portugal)

When is the study starting and how long is it expected to run for?
January 2019 to December 2023

Who is funding the study?
Portuguese Foundation for Science and Technology [Fundação para a Ciência e a Tecnologia (FCT)] (Portugal)

Who is the main contact?
1. Dr Sofia Gameiro (gameiros@cardiff.ac.uk)
2. MSc Mariana Sousa Leite (Sousaleitem@cardiff.ac.uk)