The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment

Background: Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. Methods/Design: In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring. Discussion: Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment. Trial registration: The study is registered at the Clinical Tials.gov (NCT01701011)

A population-based survey on family intentions and fertility awareness in women and men in the United Kingdom and Denmark

BACKGROUND: Across several European countries family formation is increasingly postponed. The aims of the study were to investigate the desire for family building and fertility awareness in the UK and Denmark. METHODS: A population-based internet survey was used among women (n = 1,000) and men (n = 237) from the UK (40%) and Denmark (60%). Data covered socio-demographics, family formation, and awareness of female age-related fertility. Data analysis used descriptive statistics and logistic regression analysis for studying associations between low fertility awareness and desired family formation. RESULTS: The majority of all participants desired two or three children. Two-thirds of the childless participants desired a first child at 30+ years, and one-fifth of the women and one-third of the men desired a last child at age 40. Overall, 83% of women and 73% of men were aware that female fertility starts to decline around 25–30 years. Men had significantly lower fertility awareness. Women who underestimated the impact of age on female fertility were significantly more likely to have a desire or attempted their first child at a higher age. CONCLUSION: Even though the majority were aware of the age-related decrease in female fertility, most desired having children at an age when female fertility has declined. Women who were not sufficiently aware of the impact of advanced age were significantly more likely to have their first child at a higher age. There is a need for developing educational programs for women and men in order to increase the population’s knowledge of fertility and risk factors for infertility

A population-based survey on family intentions and fertility awareness in women and men in the United Kingdom and Denmark

Background: Across several European countries family formation is increasingly postponed. The aims of the study were to investigate the desire for family building and fertility awareness in the UK and Denmark.Methods: A population-based internet survey was used among women (n?=?1,000) and men (n?=?237) from the UK (40%) and Denmark (60%). Data covered socio-demographics, family formation, and awareness of female age-related fertility. Data analysis used descriptive statistics and logistic regression analysis for studying associations between low fertility awareness and desired family formation.Results: The majority of all participants desired two or three children. Two-thirds of the childless participants desired a first child at 30+ years, and one-fifth of the women and one-third of the men desired a last child at age 40. Overall, 83% of women and 73% of men were aware that female fertility starts to decline around 25–30 years. Men had significantly lower fertility awareness. Women who underestimated the impact of age on female fertility were significantly more likely to have a desire or attempted their first child at a higher age.Conclusion: Even though the majority were aware of the age-related decrease in female fertility, most desired having children at an age when female fertility has declined. Women who were not sufficiently aware of the impact of advanced age were significantly more likely to have their first child at a higher age. There is a need for developing educational programs for women and men in order to increase the population’s knowledge of fertility and risk factors for infertility

Endometrial stromal cells of women with recurrent miscarriage fail to discriminate between high- and low-quality human embryos

Background The aetiology of recurrent miscarriage (RM) remains largely unexplained. Women with RM have a shorter time to pregnancy interval than normally fertile women, which may be due to more frequent implantation of non-viable embryos. We hypothesized that human endometrial stromal cells (H-EnSCs) of women with RM discriminate less effectively between high-and low-quality human embryos and migrate more readily towards trophoblast spheroids than H-EnSCs of normally fertile women. Methodology/Principal Findings Monolayers of decidualized H-EnSCs were generated from endometrial biopsies of 6 women with RM and 6 fertile controls. Cell-free migration zones were created and the effect of the presence of a high-quality (day 5 blastocyst, n = 13), a low-quality (day 5 blastocyst with three pronuclei or underdeveloped embryo, n = 12) or AC-1M88 trophoblast cell line spheroid on H-ESC migratory activity was analyzed after 18 hours. In the absence of a spheroid or embryo, migration of H-EnSCs from fertile or RM women was similar. In the presence of a low-quality embryo in the zone, the migration of H-EnSCs of control women was inhibited compared to the basal migration in the absence of an embryo (P<0.05) and compared to the migration in the presence of high-quality embryo (p<0.01). Interestingly, the migratory response H-EnSCs of women with RM did not differ between high- and low-quality embryos. Furthermore, in the presence of a spheroid their migration was enhanced compared to the H-EnSCs of controls (p<0.001). Conclusions H-EnSCs of fertile women discriminate between high- and low-quality embryos whereas H-EnSCs of women with RM fail to do so. H-EnSCs of RM women have a higher migratory response to trophoblast spheroids. Future studies will focus on the mechanisms by which low-quality embryos inhibit the migration of H-EnSCs and how this is deregulated in women with RM

“Her bun in my oven”: Motivations and experiences of two-mother families who have used reciprocal IVF

OBJECTIVES: What motivates same-gender female couples to choose reciprocal in vitro fertilization (IVF)? Do their experiences of becoming and being a mother via reciprocal IVF match their pre-parenthood expectations? BACKGROUND: Reciprocal IVF is a treatment route available to cis, same-gender female couples, and other couples in which both partners have a uterus and egg stores. One partner's egg is retrieved, fertilized in vitro with donor sperm, then carried by the other partner. Existing debate has considered the ethical implications of this treatment route. To date, no empirical research has explored the experiences of families who have used reciprocal IVF. METHODS: Semistructured interviews were conducted with genetic and gestational mothers in 14 families headed by cis, same gender female couples who had conceived by reciprocal IVF in the United Kingdom (N = 28 mothers). Data were analyzed according to the principles of reflexive thematic analysis. RESULTS: Four themes were constructed: (a) becoming mums together; (b) legitimacy: “who's the real mum”; (c) choices and constraints; and (d) biological connections strengthen family connections. CONCLUSION: Families had multiple and nuanced motivations for choosing reciprocal IVF, such as the desire to share the journey of motherhood with their partner, to be perceived as legitimate parents, to overcome practical barriers, and to build strong family relationships. Mothers' pre-parenthood expectations often mismatched the reality of becoming and being a mother via reciprocal IVF. Most parents found that the significance of reciprocal IVF diminished as their children grew up. IMPLICATIONS: Findings demonstrate that reciprocal IVF offers a fulfilling route to parenthood. Parents should have access to routes to parenthood that meet their reproductive needs and feel right for them as a coupl

Development, implementation and initial feasibility testing of the MediEmo mobile application to provide support during medically assisted reproduction.

STUDY QUESTION Is it possible to develop a patient smartphone application for medically assisted reproduction (MAR) that is acceptable to patients and fertility staff? SUMMARY ANSWER Staff and patients responded positively to the MediEmo smartphone application, perceiving it to be acceptable and feasible to implement in a busy clinic. WHAT IS KNOWN ALREADY Digital tools are increasingly popular to provide practical, administrative and psychological support alongside medical treatments. Apps and other digital tools have been developed for use alongside MAR but there is very limited research on the development or acceptability and feasibility of these tools. STUDY DESIGN, SIZE, DURATION Mixed methods research. This article outlines the development phase of the MediEmo smartphone app, which was guided by the Medical Research Council development framework for complex interventions. The resulting MediEmo app was then implemented into a single centre for MAR in the UK, acceptability evaluated and feasibility explored among 1106 potential participants undertaking IVF cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS Consultation and data collection took part at a single mid-sized urban fertility clinic. Development of the MediEmo smartphone application took place during 2013 to 2017. Implementation of the MediEmo took place from June 2017 to September 2020. The MediEmo app comprises three functions (six features) namely medication management (medication timeline, messaging), mood management (emotional tracking, coping support) and functional support (frequently asked questions, symptom checker). Data on age, fertility diagnosis, anti-Müllerian hormone level were collected about the users of the MediEmo in addition to MediEmo usage data and attitudes towards the MediEmo smartphone application. MAIN RESULTS AND THE ROLE OF CHANCE Informed by the developmental process described, MediEmo is an app combining patient medication diary management and ease of integration into clinic systems with emotional support, emotional tracking and data capture. This study demonstrates acceptability and feasibility of MediEmo, with good uptake (79.8%), mood data sensitivity and reliability and positive feedback. LIMITATIONS, REASONS FOR CAUTION Single centre, small number of users in questionnaire studies. WIDER IMPLICATIONS OF THE FINDINGS The findings suggest smartphone apps can contribute to fertility care and that patient engagement is high. Evaluation of any apps introduced into clinical pathways should be encouraged to promote development of the most useful digital tools for fertility patients. STUDY FUNDING/COMPETING INTEREST(S) This research did not receive any specific grant from any funding agency in the public, commercial or not-for-profit sector. Outside of the submitted work, J.B. reports personal speaker fees from Merck KGaA, Darmstadt, Germany, Merck AB an affiliate of Merck KGaA, Darmstadt Germany, Theramex, MedThink China, Ferring Pharmaceuticals A/S, grant from Merck Serono Ltd, outside the submitted work and that she is co-developer of Fertility Quality of Life (FertiQoL) and MediEmo app; N.M and C.Y are minority shareholders and J.B.'s University (Cardiff University) owns one third of shares. None of the shareholders benefitted financially from MediEmo. I.R., C.H. and K.Y.B.N. declare no conflicts of interest