P-498 Multicentre two-arm randomised controlled trial of Beyond Fertility: A brief face-to-face psychosocial intervention to promote patients’ healthy adjustment when ending unsuccessful fertility treatment
Authors: Sousa Leite M , Costa R , Figueiredo B , Liu J , Morey R , Gameiro S 
Published: July 2024

Abstract

Study question
Is Beyond Fertility effective in ameliorating the negative impact of ending unsuccessful fertility treatment (EoT) on patients’ quality of life?

Summary answer
Patients allocated to Beyond Fertility (intervention group) reported higher quality of life six months after EoT than patients allocated to care as usual (control group).

What is known already
Around four in every ten patients end all IVF/ICSI treatment cycles without achieving a live birth (referred as EoT). Recent mixed-methods research indicates 93.3% of patients want to be prepared for and supported through EoT. Two interventions have been proven to improve the wellbeing of people with an unfulfilled wish for children after they proactively started trying to conceive, but, to our knowledge, no intervention focused on preparing and supporting fertility patients through this experience. Following the Medical Research Council guidelines, we developed Beyond Fertility, a face-to-face psychosocial intervention integrating preventive with early-interventive care to ease patients’ adjustment during EoT.

Study design, size, duration
Multicentre two-arm parallel-group open-label RCT with 1:1 allocation to intervention (Beyond Fertility) or control (usual mental-healthcare at participating clinics, CaU). Beyond Fertility includes seven therapeutic sessions: one (individual/couple) within one month the last IVF/ICSI cycle (preventive care) and six (individual/couple and group) sessions after EoT (early-interventive care). Participants self-reported on quality-of-life one month before their last reimbursed IVF/ICSI cycle (T1, pre-session 1), two weeks (T2, post-session 1) and six months (T4, post-intervention) after cycle ended.

Participants/materials, setting, methods
Women patients were consecutively screened and invited to participate with their partners at four public fertility centres in Portugal (Dez 2021-Mar 2023). Inclusion criteria were being adults scheduled to initiate their last reimbursed IVF/ICSI cycle within one month. Primary outcome was quality-of-life, self-reported online with FertiQoL (Melo et al., 2012). Linear-mixed-effect models compared changes in quality-of-life from T1 to T2 and T4 in intervention and control groups. Outcome data were reported for modified intention-to-treat (mITT).

Main results and the role of chance
From 143 eligible women(90.51% eligibility rate), 74(51.75% consent rate) and 41 partners completed T1 assessment(N=115) and were allocated to Beyond Fertility(n=60) or CaU(n=55). Average age was 38 years. Sixty-four percent were women, 62% had university education, 92% were employed, all were in a heterosexual relationship, and 30% had children. Participants were undergoing treatment for around three years. Fourteen(14.14%) achieved a pregnancy in their last reimbursed IVF/ICSI cycle, 34(34.34%) did not achieve a pregnancy and ended treatment (i.e. faced EoT), and 51(51.52%) did not achieve a pregnancy and continued treatment.
Among participants who were allocated to Beyond Fertility and faced EoT, eight(44.44%) withdrew from its early-interventive care mainly due to not accepting the group format, and only four(22.22%) received the full intervention due to practicality issues.
Among participants who faced EoT, participation rates for Beyond Fertility and CaU groups were 88.89%(n=16) and 100%(n=16) at T2, and 77.78%(n=14) and 93.75%(n=15) at T4, respectively. Among these participants, those allocated to Beyond Fertility had an estimated mean quality-of-life score around 6 points higher than participants allocated to CaU at T2 (β=6.17, p=0.113) and around 9 points higher (almost one standard deviation above the baseline mean of the total sample) at T4 (β=8.95, p=0.035).

Limitations, reasons for caution
The trial was not blind, and therefore, response bias cannot be ignored. Attrition was slightly higher in the Beyond Fertility than the CaU group, suggesting that mITT may marginally overestimate the effect of Beyond Fertility.

Wider implications of the findings
Structured psychosocial care that starts during treatment and continues in its aftermath to support patients who end treatment without achieving pregnancy is effective in ameliorating declines in quality-of-life, suggesting it can ease adjustment during this difficult life transition. Benefits may be maximised by tailoring it to patients’ preferred delivery format.

Trial registration number
ISRCTN Registry ISRCTN85897617