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

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)

Study website

Type

Principal Investigator

Contact name

Dr Sofia Gameiro

ORCID ID

http://orcid.org/0000-0003-2496-2004

Contact details

School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
+44 (0)29 2087 5376
gameiros@cardiff.ac.uk

Type

Principal Investigator

Contact name

Ms Mariana Sousa Leite

ORCID ID

http://orcid.org/0000-0002-8002-4648

Contact details

School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
-
sousaleitem@cardiff.ac.uk

Type

Scientific

Contact name

Dr Sofia Gameiro

ORCID ID

http://orcid.org/0000-0003-2496-2004

Contact details

School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
+44 (0)29 2087 5376
gameiros@cardiff.ac.uk

Type

Scientific

Contact name

Ms Mariana Sousa Leite

ORCID ID

http://orcid.org/0000-0002-8002-4648

Contact details

School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
-
sousaleitem@cardiff.ac.uk

Type

Public

Contact name

Ms Mariana Sousa Leite

ORCID ID

http://orcid.org/0000-0002-8002-4648

Contact details

School of Psychology
Cardiff University
Tower Building
70 Park Place
Cardiff
CF10 3AT
United Kingdom
-
sousaleitem@cardiff.ac.uk

EudraCT/CTIS number

Nil known

IRAS number

ClinicalTrials.gov number

Nil known

Secondary identifying numbers

Nil known

Scientific title

Efficacy evaluation of a psychosocial intervention - Beyond Fertility - versus care as usual, to promote fertility patients’ quality of life after unsuccessful fertility treatment: a multicentre randomised controlled trial

Acronym

Beyond Fertility: Efficacy trial

Study hypothesis

1. It is expected that the quality of life of those fertility patients who are allocated to the psychosocial intervention (i.e., Beyond Fertility) will improve (moderate effect size expected) from baseline (i.e., within 1 month before the patients' scheduled date to initiate the last in vitro fertilisation/intracytoplasmic sperm injection (IVF/ICSI) treatment cycle reimbursed by the NHS) to 6 months after unsuccessful treatment, and remain stable for those allocated to receive care as usual.
2. It is also expected that the mental health and wellbeing of those fertility patients who are allocated to the psychosocial intervention (i.e., Beyond Fertility) will improve (small to moderate effect size expected) from baseline to 6 months after unsuccessful treatment, and remain stable for those allocated to receive care as usual.

Ethics approval(s)

1. Approved 18/06/2021, School of Psychology Research Ethics Committee of Cardiff University (Tower Building, 70 Park Place, Cardiff, CF10 3AT, UK; +44 (0)29 2087 0360; psychethics@cardiff.ac.uk), ref: EC.21.05.18.6351A
2. Approved 19/02/2021, University Hospital Centre of São João/Faculty of Medicine of the University of Porto [Centro Hospitalar Universitário de São João (CHUSJ)/Faculdade de Medicina da Universidade do Porto (FMUP)] Ethics Committee (Alameda Professor Hernâni Monteiro, Porto, 4200-319, PT; +351 (0)225 512 126; comissao.etica@chsj.min-saude.pt), ref: 127/2020
3. Approved 21/04/2021, University Hospital Centre of Porto/Institute of Biomedical Sciences Abel Salazar [Centro Hospitalar Universitário do Porto (CHUPorto)/Instituto de Ciências Biomédicas Abel Salazar (ICBAS)] Ethics Committee (Largo do Professor Abel Salazar, Porto, 4099-001, PT; +351 (0)222 077 500; secretariado.etica@chporto.min-saude.pt), ref: 2020.204(161-DEFI/162-CE)
4. Approved 17/03/2022, Lisbon Academic Medical Centre [Centro Académico de Medicina de Lisboa (CAML)] Ethics Committee (Avenida Professor Egas Moniz, Lisboa, 1649-035, PT; +351 (0)217 805 405; comissaoeticacaml@chln.min-saude.pt), ref: 398/21
5. Approved 24/08/2022, Central Lisbon University Hospital Centre [Centro Hospitalar Universitário de Lisboa Central] Ethics Committee (Rua José António Serrano, Lisboa, 1150-199, PT; +351 (0)213 514 410; comissao.etica@chlc.min-saude.pt), ref: 1244/2022

Study design

Two-arm parallel-group non-blinded multicentre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

https://cardiffunipsych.eu.qualtrics.com/jfe/form/SV_8B2oEjKcTm8DkY6

Condition

Fertility health problems

Intervention

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 sociodemographic characteristics, fertility treatment history, psychosocial mediators - mechanisms of change, and outcomes) are assigned (non-blind) to one of these two groups: intervention; 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 parenthood status (childless; 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 power of 90%. Driven by the inclusion criteria and results from a preceding feasibility study, a minimum of 540 eligible patients needs to be recruited.

The intervention group receives 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 (Zoom Video Communications, 2012). It is rooted in the Three Tasks Model (3TM; 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 Fertility encompasses preventive and early intervention care throughout seven therapeutic sessions. Preventive care comprises one first session (in an individual/couple format) to be delivered within 1 month before the patients' scheduled date to initiate the last IVF/ICSI treatment cycle reimbursed by the NHS. Early intervention care comprises the following six 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 sessions are only directed at those patients who experience an unsuccessful cycle and are not offered or do not plan to undergo an additional treatment cycle. Those patients who experience a successful outcome (i.e., a positive beta hCG) or decide to undergo an additional cycle do not receive the early intervention care (still, they complete the evaluation process, which encompasses four assessment timepoints - described below).

The care as usual group receives the mental healthcare currently offered in the clinics.

Intervention type

Behavioural

Primary outcome measure

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

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.

Overall study start date

01/01/2019

Overall study end date

31/12/2023

Reason abandoned (if study stopped)

Participant 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])

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

540

Participant 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

Recruitment start date

28/12/2021

Recruitment end date

31/05/2023

Countries of recruitment

Portugal

Study participating centre

University Hospital Centre of São João [Centro Hospitalar Universitário de São João (CHUSJ)]
Department of Reproductive Medicine
Alameda Professor Hernâni Monteiro.
Porto
4200-319
Portugal

Study participating centre

University Hospital Centre of Porto [Centro Hospitalar Universitário do Porto (CHUP)]
Northern Maternal and Child Centre [Centro Materno Infantil do Norte (CMIN)]
Medically Assisted Reproductive centre
Largo da Maternidade de Júlio Dinis 45
Porto
4050-651
Portugal

Study participating centre

Northern Lisbon University Hospital Centre [Centro Hospitalar Universitário de Lisboa Norte]
Santa Maria Hospital [Hospital de Santa Maria]
Department of Obstetrics, Gynaecology and Reproductive Medicine
Avenida Professor Egas Moniz
Lisbon
1649-035
Portugal

Study participating centre

Central Lisbon University Hospital Centre [Centro Hospitalar Universitário de Lisboa Central]
Dr Alfredo da Costa Maternity [Maternidade Dr. Alfredo da Costa]
Department of Reproductive Medicine
Rua Viriato
Lisbon
2890-495
Portugal

Organisation

Cardiff University

Sponsor details

School of Psychology
Tower Building
70 Park Place
Cardiff
CF10 3AT
Wales
United Kingdom
+44 (0)29 2087 4000
psychenquiries@cardiff.ac.uk

Sponsor type

University/education

Website

https://www.cardiff.ac.uk/psychology

ROR

https://ror.org/03kk7td41

Organisation

Institute of Public Health of the University of Porto (ISPUP)

Sponsor details

Rua das Taipas 135
Porto
4050-600
Portugal
+351 (0)222 061 820
geral@ispup.up.pt

Sponsor type

University/education

Website

https://ispup.up.pt

Funder type

Government

Funder name

Fundação para a Ciência e a Tecnologia

Alternative name(s)

Foundation for Science and Technology, Portuguese Science and Technology Foundation, Fundacao para a Ciencia e a Tecnologia, FCT

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Portugal

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal. It is also expected to disseminate the trial results in international conferences (e.g., European Society of Human Reproduction and Embryology [ESHRE] Annual Meetings), and intended to make Beyond Fertility easily accessed and free of cost for mental healthcare professionals via the research group website and other support websites if effectiveness is found.

Intention to publish date

28/12/2024

Individual participant data (IPD) Intention to share

Yes

IPD sharing plan

The datasets underlying the current trial will be available upon reasonable request and approval from Dr Sofia Gameiro (gameiros@cardiff.ac.uk) and MSc Mariana Sousa Leite (sousaleitem@cardiff.ac.uk). Data will be retained for a minimum period of 15 years after the end of the project or after the publication of any findings based upon the data (whichever is later). Personal data will be deleted, and the research data will be effectively anonymised. These data will be made available at the same time as the publication of the project's findings (expected date: 31/12/2024) but will only be shared for research purposes upon reasonable request and approval from Cardiff University - consent from participants was obtained.

IPD sharing plan summary

Available on request

Study outputs