Henrietta Ockhuijsen1, Agnes van den Hoogen2, Marinus Eijkemans3, Nick Macklon4, Jacky Boivin5. 1. Department of Reproductive Medicine and Gynaecology, University Medical Centre Utrecht, Utrecht, The Netherlands h.d.l.ockhuysen@umcutrecht.nl. 2. Department of Neonatology, Wilhelmina Children's Hospital and University Medical Centre Utrecht, Utrecht, The Netherlands. 3. Julius Centre for Health Science and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands. 4. Academic Unit of Human Development and Health, University of Southampton, Southampton, UK. 5. School of Psychology, Cardiff University, Cardiff, UK.
Abstract
STUDY QUESTION: Does the use of a positive reappraisal coping intervention (PRCI) alone following IVF embryo transfer influence anxiety, the depression and treatment outcome when compared with its use combined with monitoring emotions, monitoring emotions alone or no intervention? SUMMARY ANSWER: Woman using the PRCI alone had significantly lower anxiety levels at Day 10 of the waiting period and 6 weeks after the start of the waiting period but also a significantly higher clinical pregnancy rate compared with the other three groups. WHAT IS KNOWN ALREADY: The waiting period, which follows embryo transfer after IVF/ICSI is very stressful. The use of the PRCI together with a daily monitoring form increases positive emotions but appears not to reduce anxiety. The impact of using the PRCI without daily recording of emotions may be more beneficial. STUDY DESIGN, SIZE, DURATION: Following completion of recruitment to a recently published 3-arm randomized controlled trial (RCT) of the use of the PRCI in the post-embryo transfer waiting period, a further 110 participants were recruited to study the impact of the PRCI in clinical practice without concurrent emotional monitoring. Data collection took place between May 2012 and December 2012. Outcomes were compared with those generated by a RCT of the PRCI with daily emotional monitoring, daily emotional monitoring only or routine care. PARTICIPANT, MATERIALS, SETTING, METHODS: To capture the impact of the PRCI on this further group, questionnaires were completed at three time points: just before the waiting period (Time 1: preintervention), on Day 10 of the 14-day waiting period (Time 2: waiting period intervention) and 6 weeks after the start of the waiting period (Time 3: post-intervention). Data generated were compared with the data from the RCT. To compare the impact over time on anxiety and depression, a repeated multilevel linear model design was used. MAIN RESULTS AND THE ROLE OF CHANCE: Nighty-eight of the 110 women who were recruited received thePRCI intervention without daily monitoring (PRCI-comparison group). After correcting for known confounding factors, compared with women in all three groups of the original RCT, women in the PRCI-comparison group had a significantly lower anxiety at Time 2 (n = 83) and Time 3 (n = 70) but not significantly lower depression levels. Women in the PRCI-comparison group had a significantly higher clinical pregnancy rate (39.8%, P = 0.033) but there were no significant differences in clinical pregnancies with fetal heartbeat (P = 0.10). LIMITATIONS, REASONS FOR CAUTION: A limitation of this study is that the additional study group was not randomized to the intervention, and may therefore be subject to selection bias. The study was also done subsequent to the other three groups. WIDER IMPLICATIONS OF THE FINDINGS: This simple low cost self-help coping intervention can be offered to women during the waiting period in an IVF/ICSI treatment. A further RCT comparing PRCI only to a non-intervention group is necessary to confirm these findings. STUDY FUNDING/COMPETENT INTERESTS: The Women and Baby Division of the University Medical Centre Utrecht funded the study. The authors have no conflicting interest(s).
RCT Entities:
STUDY QUESTION: Does the use of a positive reappraisal coping intervention (PRCI) alone following IVF embryo transfer influence anxiety, the depression and treatment outcome when compared with its use combined with monitoring emotions, monitoring emotions alone or no intervention? SUMMARY ANSWER: Woman using the PRCI alone had significantly lower anxiety levels at Day 10 of the waiting period and 6 weeks after the start of the waiting period but also a significantly higher clinical pregnancy rate compared with the other three groups. WHAT IS KNOWN ALREADY: The waiting period, which follows embryo transfer after IVF/ICSI is very stressful. The use of the PRCI together with a daily monitoring form increases positive emotions but appears not to reduce anxiety. The impact of using the PRCI without daily recording of emotions may be more beneficial. STUDY DESIGN, SIZE, DURATION: Following completion of recruitment to a recently published 3-arm randomized controlled trial (RCT) of the use of the PRCI in the post-embryo transfer waiting period, a further 110 participants were recruited to study the impact of the PRCI in clinical practice without concurrent emotional monitoring. Data collection took place between May 2012 and December 2012. Outcomes were compared with those generated by a RCT of the PRCI with daily emotional monitoring, daily emotional monitoring only or routine care. PARTICIPANT, MATERIALS, SETTING, METHODS: To capture the impact of the PRCI on this further group, questionnaires were completed at three time points: just before the waiting period (Time 1: preintervention), on Day 10 of the 14-day waiting period (Time 2: waiting period intervention) and 6 weeks after the start of the waiting period (Time 3: post-intervention). Data generated were compared with the data from the RCT. To compare the impact over time on anxiety and depression, a repeated multilevel linear model design was used. MAIN RESULTS AND THE ROLE OF CHANCE: Nighty-eight of the 110 women who were recruited received the PRCI intervention without daily monitoring (PRCI-comparison group). After correcting for known confounding factors, compared with women in all three groups of the original RCT, women in the PRCI-comparison group had a significantly lower anxiety at Time 2 (n = 83) and Time 3 (n = 70) but not significantly lower depression levels. Women in the PRCI-comparison group had a significantly higher clinical pregnancy rate (39.8%, P = 0.033) but there were no significant differences in clinical pregnancies with fetal heartbeat (P = 0.10). LIMITATIONS, REASONS FOR CAUTION: A limitation of this study is that the additional study group was not randomized to the intervention, and may therefore be subject to selection bias. The study was also done subsequent to the other three groups. WIDER IMPLICATIONS OF THE FINDINGS: This simple low cost self-help coping intervention can be offered to women during the waiting period in an IVF/ICSI treatment. A further RCT comparing PRCI only to a non-intervention group is necessary to confirm these findings. STUDY FUNDING/COMPETENT INTERESTS: The Women and Baby Division of the University Medical Centre Utrecht funded the study. The authors have no conflicting interest(s).