Correlation Between Surgical Phenotype and Pain Improvement After Endometriosis Surgery.

STUDY OBJECTIVE: To examine pain improvement after endometriosis surgery and whether it can be predicted by the observed surgical phenotype. DESIGN: Prospective longitudinal survey study. SETTING: A University hospital. PATIENTS: A total of 125 patients completed a preoperative questionnaire (response rate: n = 227 of 277, 81.9%), had surgically confirmed endometriosis (n = 202 of 227), and returned a second postoperative questionnaire (response rate: n = 125 of 202, 61.9%). INTERVENTIONS: All patients underwent complete laparoscopic removal of the endometriotic lesions. Surgical phenotype was classified according to the rASRM and #Enzian classification. MEASUREMENTS AND MAIN RESULTS: The intensity of 5 specific pain symptoms was questioned by postal paper-pencil questionnaires with a numerical rating scale (0-10) both preoperatively (3.01 ± 2.72 months before surgery) and one year after surgery (12.62 ± 1.59 months). A postoperative pain improvement score was computed (postoperative pain-preoperative pain) for each specific pain symptom (0-10) and for the overall/global pain sum score (0-50). The mean intensity of all pain scores was lower postoperatively as compared with preoperatively (p <.0001). A statistically significant weak correlation was observed between the surgical phenotype "rectovaginal endometriosis" and postoperative improvement of dyspareunia (r = .265; p = .003). The other 11 hypothesized correlations between surgical phenotype and postoperative improvement of pain intensity failed to reach statistical significance. CONCLUSION: Clinicians can inform patients that surgery is effective in reducing endometriosis-related pain symptoms and the overall/global pain scores at 12 months postoperatively. From our data, we can conclude that patients with rectovaginal endometriosis might benefit the most from the reduction of their sexual pain. On the basis of these results, we could suggest that deep dyspareunia (even if present as an isolated symptom) might be a valid indication for surgery. Further research could explore the association between a certain surgical phenotype and more detailed assessments of sexual functioning, as well as explore whether feedback from the surgeon on expected pain improvement affects patient-reported outcomes.

Belgian Fertility Clinic Staff Value Healthy Lifestyle Promotion but Lack Access to a Structured Lifestyle Modification Programme: An Observational Study.

OBJECTIVES: Guidelines advise promoting a healthy lifestyle among patients with fertility problems as the lifestyle of women and men proved to be associated with their fertility. Australian fertility nurses were shown to lack access to structured lifestyle modification programmes, although they value healthy lifestyle promotion. This study aimed to examine whether gynaecologists also value promoting a healthy lifestyle and whether structured lifestyle modification programmes are available in Belgian fertility clinics. DESIGN: An observational study was conducted among health care professionals (HCPs) working in Belgian fertility clinics. PARTICIPANTS/MATERIALS, SETTING, METHODS: An Australian questionnaire on attitudes and practices related to promoting a healthy lifestyle among patients with fertility problems was reciprocally back-to-back translated and three open-ended questions were added. All HCPs of Belgian fertility clinics, including gynaecologists, fertility nurses/midwives, psychologists, and embryologists, were invited by e-mail to complete the questionnaire online. Responses to closed and open-ended questions were analysed with, respectively, descriptive statistics and qualitative thematic analysis. Finally, differences in perspectives between different groups of HCPs were explored. RESULTS: A total of 50 fertility nurses/midwives, 42 gynaecologists, and 19 other HCPs completed the survey (n = 111). Regarding attitudes, all respondents valued informing patients about the impact of lifestyle on fertility. The vast majority of HCPs (n = 96; 86%) stated that fertility clinics have the responsibility to address unhealthy lifestyles prior to offering fertility treatment. Fertility nurses/midwives were significantly more likely than gynaecologists to state that fertility clinics have this responsibility (p = 0.040). Regarding practices, the patient's lifestyle was most commonly discussed by the gynaecologist (n = 107; 96%) during the first appointment (n = 105; 95%). The lifestyle factors that were being addressed, according to the vast majority of respondents, were smoking, weight, age, alcohol, and recreational drugs. Only three HCPs (from three different clinics) stated that their clinic offered a structured lifestyle modification programme. HCPs explained that they lacked the resources and expertise for offering a structured lifestyle modification programme. LIMITATIONS: Response rates were limited, but the responding Belgian gynaecologists and fertility nurses/midwives confirmed the findings of the previous study in Australian fertility nurses. CONCLUSIONS: HCPs working in Belgian fertility clinics value healthy lifestyle promotion but lack access to structured lifestyle modification programmes to implement in their daily clinical practice. Future studies should focus on developing and evaluating structured lifestyle modification programmes for patients with fertility problems.

The Impact of Chronic Endometritis on Infertility: Prevalence, Reproductive Outcomes, and the Role of Hysteroscopy as a Screening Tool.

OBJECTIVES: The objective of this study was to examine the prevalence of chronic endometritis (CE) in infertile women, its impact on reproductive outcomes, and the accuracy of hysteroscopy as a screening tool for CE. DESIGN: This was a prospective observational study. PARTICIPANTS: Participants involved in this study were 514 asymptomatic patients with infertility. SETTING: The review was conducted in a tertiary care center. METHODS: The participants underwent a hysteroscopy and endometrial biopsy (EMB). Antibiotics were given for cases of CE. We investigated the prevalence of CE in patients starting assisted reproductive technologies (ART) as a primary outcome. Secondary outcomes were the clinical pregnancy rate (CPR) in the ART cycle after hysteroscopy, EMB, and antibiotic treatment in cases of CE; the cumulative CPR in the subsequent 2 years after hysteroscopy and EMB; the sensitivity and specificity of hysteroscopy as a screening tool compared to EMB as the "gold standard" for diagnosing CE. RESULTS: CE was identified in 2.8% of patients starting ART (11/393). CPRs did not differ significantly between patients with CE and the entire cohort of patients without CE in the subsequent ART cycle (OR: 0.43; 95% CI: 0.09-2.02) or in the 2 years after EMB (OR: 0.56; 95% CI: 0.16-1.97). In a matched control comparison (with matching for age, basal FSH, and cause of infertility), CPR in patients with CE did not differ in the subsequent ART cycle (OR: 0.39; 95% CI: 0.09-1.61); however, their CPR in the 2 years after EMB was significantly lower (OR: 0.22; 95% CI: 0.13-0.38). The sensitivity and specificity of hysteroscopy as a screening tool for diagnosing CE were 8.3% and 90.1%, respectively. LIMITATIONS: Due to our cohort's low CE prevalence, we could not detect significant differences in CPRs. CONCLUSION: CE is rare in our studied population of asymptomatic patients starting ART. Hysteroscopy cannot replace EMB for diagnosing CE.

The Relation between Patient-Centered Care and Quality of Life in Women with Endometriosis.

OBJECTIVE: The objective of this study was to examine the hypothesis that experiences with patient-centered endometriosis care are related to the endometriosis-specific quality of life dimensions "emotional well-being" and "social support." DESIGN: A secondary regression analysis of two cross-sectional studies was conducted. Participants/Materials: In total, data from 300 women were eligible for analysis. The participating women all had surgically proven endometriosis. SETTING: The study was conducted in one secondary and two tertiary endometriosis clinics in the Netherlands. Questionnaires were disseminated between 2011 and 2016. METHODS: Both included studies investigated patient-centeredness of endometriosis care and endometriosis-specific quality of life using, respectively, the ENDOCARE questionnaire (ECQ) and the Endometriosis Health Profile 30 (EHP-30). To increase power, the regression analysis focused on the previously found relation between the ten dimensions of the ECQ and the EHP-30 domains "emotional well-being" and "social support" rather than all five EHP-30 domains. After the Bonferroni correction to limit type 1 errors, the adjusted p value was 0.003 (0.05/20). RESULTS: The participating women had a mean age of 35.7 years and had predominantly been diagnosed with moderate to severe endometriosis. None of the relations between patient-centered endometriosis care and the EHP-30 domain "emotional well-being" were significant. Three dimensions of patient-centered endometriosis care proved to be significantly related to the EHP-30 domain "social support": "information, communication, and education" (p < 0.001, beta = 0.436), "coordination and integration of care" (p = 0.001, beta = 0.307), and "emotional support and alleviation of fear and anxiety" (p = 0.002, beta = 0.259). LIMITATIONS: This cross-sectional study identified relations rather than proving causality between experiencing less patient-centeredness of care and having lower quality of life. Nevertheless, it is very tangible that some causality exists, either directly or indirectly (e.g., through empowerment) and that by improving patient-centeredness, quality of life might be improved as well. CONCLUSION: "Information, communication, and education"; "coordination and integration of care"; and "emotional support and alleviation of fear and anxiety" as dimensions of patient-centered endometriosis care are related to the quality of life domain "social support" of women with endometriosis. Improving the patient-centeredness of endometriosis care was already considered an important goal, but even more so given its relation with women's quality of life, which is increasingly considered the ultimate measure of health care quality. Quality improvement projects focusing on "information, communication, and education" are expected to impact women's quality of life the most.

Single-embryo transfer implies quality of care in reproductive medicine.

This review appraises evidence on the difference between single- and double-embryo transfer (SET, DET) in assisted reproductive technology (ART) regarding the four healthcare quality dimensions most important to fertility patients and doctors. Regarding safety, not only does DET create the uncontested perinatal risks of twin pregnancies, but compelling evidence has added that singleton pregnancies after a vanishing twin also have poorer perinatal outcomes. SET is as effective as DET, as shown by meta-analyses of randomized controlled trials, comparing two cycles of SET versus DET and shown by cumulative live birth rates of entire ART trajectories of up to six cycles. Proposing SET, which is safer than DET and as effective, as the gold standard is not irreconcilable with patient-centred care if patients are thoroughly informed on the reasoning behind the proposition and welcomed to challenge whether it fits their personal values. The cost-efficiency of SET is clearly higher, which has even induced certain countries to start reimbursing ART on the condition that SET is used. In conclusion, SET should be the gold standard offered to all patients. The question is not whether to apply SET but how to apply it in terms of patient selection, patient-centred counselling and coverage of treatment.

Preconception lifestyle advice for people with infertility.

BACKGROUND: Infertility is a prevalent problem that has significant consequences for individuals, families, and the community. Modifiable lifestyle factors may affect the chance of people with infertility having a baby. However, no guideline is available about what preconception advice should be offered. It is important to determine what preconception advice should be given to people with infertility and to evaluate whether this advice helps them make positive behavioural changes to improve their lifestyle and their chances of conceiving. OBJECTIVES: To assess the safety and effectiveness of preconception lifestyle advice on fertility outcomes and lifestyle behavioural changes for people with infertility. SEARCH METHODS: We searched the Cochrane Gynaecology and Fertility Group Specialised Register of controlled trials, CENTRAL, MEDLINE, Embase, PsycINFO, AMED, CINAHL, trial registers, Google Scholar, and Epistemonikos in January 2021; we checked references and contacted field experts to identify additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), randomised cross-over studies, and cluster-randomised studies that compared at least one form of preconception lifestyle advice with routine care or attention control for people with infertility. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. Primary effectiveness outcomes were live birth and ongoing pregnancy. Primary safety outcomes were adverse events and miscarriage. Secondary outcomes included reported behavioural changes in lifestyle, birth weight, gestational age, clinical pregnancy, time to pregnancy, quality of life, and male factor infertility outcomes. We assessed the overall quality of evidence using GRADE criteria. MAIN RESULTS: We included in the review seven RCTs involving 2130 participants. Only one RCT included male partners. Three studies compared preconception lifestyle advice on a combination of topics with routine care or attention control. Four studies compared preconception lifestyle advice on one topic (weight, alcohol intake, or smoking) with routine care for women with infertility and specific lifestyle characteristics. The evidence was of low to very low-quality. The main limitations of the included studies were serious risk of bias due to lack of blinding, serious imprecision, and poor reporting of outcome measures. Preconception lifestyle advice on a combination of topics versus routine care or attention control Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.79 to 1.10; 1 RCT, 626 participants), but the quality of evidence was low. No studies reported on adverse events or miscarriage. Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice on a combination of topics affects lifestyle behavioural changes: body mass index (BMI) (mean difference (MD) -1.06 kg/m², 95% CI -2.33 to 0.21; 1 RCT, 180 participants), vegetable intake (MD 12.50 grams/d, 95% CI -8.43 to 33.43; 1 RCT, 264 participants), alcohol abstinence in men (RR 1.08, 95% CI 0.74 to 1.58; 1 RCT, 210 participants), or smoking cessation in men (RR 1.01, 95% CI 0.91 to 1.12; 1 RCT, 212 participants). Preconception lifestyle advice on a combination of topics may result in little to no difference in the number of women with adequate folic acid supplement use (RR 0.98, 95% CI 0.95 to 1.01; 2 RCTs, 850 participants; I² = 4%), alcohol abstinence (RR 1.07, 95% CI 0.99 to 1.17; 1 RCT, 607 participants), and smoking cessation (RR 1.01, 95% CI 0.98 to 1.04; 1 RCT, 606 participants), on low quality evidence. No studies reported on other behavioural changes. Preconception lifestyle advice on weight versus routine care Studies on preconception lifestyle advice on weight were identified only in women with infertility and obesity. Compared to routine care, we are uncertain whether preconception lifestyle advice on weight affects the number of live births (RR 0.94, 95% CI 0.62 to 1.43; 2 RCTs, 707 participants; I² = 68%; very low-quality evidence), adverse events including gestational diabetes (RR 0.78, 95% CI 0.48 to 1.26; 1 RCT, 317 participants; very low-quality evidence), hypertension (RR 1.07, 95% CI 0.66 to 1.75; 1 RCT, 317 participants; very low-quality evidence), or miscarriage (RR 1.50, 95% CI 0.95 to 2.37; 1 RCT, 577 participants; very low-quality evidence). Regarding lifestyle behavioural changes for women with infertility and obesity, preconception lifestyle advice on weight may slightly reduce BMI (MD -1.30 kg/m², 95% CI -1.58 to -1.02; 1 RCT, 574 participants; low-quality evidence). Due to very low-quality evidence, we are uncertain whether preconception lifestyle advice affects the percentage of weight loss, vegetable and fruit intake, alcohol abstinence, or physical activity. No studies reported on other behavioural changes. Preconception lifestyle advice on alcohol intake versus routine care Studies on preconception lifestyle advice on alcohol intake were identified only in at-risk drinking women with infertility. We are uncertain whether preconception lifestyle advice on alcohol intake affects the number of live births (RR 1.15, 95% CI 0.53 to 2.50; 1 RCT, 37 participants; very low-quality evidence) or miscarriages (RR 1.31, 95% CI 0.21 to 8.34; 1 RCT, 37 participants; very low-quality evidence). One study reported on behavioural changes for alcohol consumption but not as defined in the review methods. No studies reported on adverse events or other behavioural changes. Preconception lifestyle advice on smoking versus routine care Studies on preconception lifestyle advice on smoking were identified only in smoking women with infertility. No studies reported on live birth, ongoing pregnancy, adverse events, or miscarriage. One study reported on behavioural changes for smoking but not as defined in the review methods. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that preconception lifestyle advice on a combination of topics may result in little to no difference in the number of live births. Evidence was insufficient to allow conclusions on the effects of preconception lifestyle advice on adverse events and miscarriage and on safety, as no studies were found that looked at these outcomes, or the studies were of very low quality. This review does not provide clear guidance for clinical practice in this area. However, it does highlight the need for high-quality RCTs to investigate preconception lifestyle advice on a combination of topics and to assess relevant effectiveness and safety outcomes in men and women with infertility.

Hormonal medication in medically assisted reproduction: a systematic review of assessments from patients.

Several hormonal fertility medications have comparable effectiveness. A literature review was conducted into patients' assessments regarding seven medication characteristics including 'side effects' and 'ease of use'. Medline, CINAHL and PsycINFO were searched for female fertility patients' written assessments of a hormonal medication. The tools used were appraised and common (i.e. ≥10%) unpleasant consequences were distinguished from rare ones. The 35 eligible studies did not rely on valid and reliable tools and did not provide patient assessments regarding all seven medication characteristics for any of the globally used medications. Evidence on medications for oocyte triggering was absent and for induction of pituitary quiescence it was scarce. Regarding medications for ovarian stimulation and luteal support, evidence on general side effects (mostly headache), local side effects (mostly pain), 'interference with home life' and 'impact on psychological wellbeing' was found. Evidence on 'ease of use' and 'required education' was only identified for medication for ovarian stimulation. Evidence on 'interference with work life' and 'compliance worry' was absent. This review calls for randomized controlled trials questioning patients with valid and reliable tools. In the meantime, this review's summary of the best available evidence can be integrated in decision aids facilitating personalized and informed medication choices.

The relative importance of genetic parenthood.

RESEARCH QUESTION: How much do patients with severe infertility and their gynaecologists value genetic parenthood relative to other key treatment characteristics? DESIGN: A discrete choice experiment included the following treatment characteristics: genetic parenthood, pregnancy rate, curing infertility, maternal health, child health and costs. The questionnaire was disseminated between 2015 and 2016 among Dutch and Belgian patients with severe infertility and their gynaecologists. RESULTS: The questionnaire was completed by 173 patients and 111 gynaecologists. When choosing between treatments that varied in safety, effectiveness and costs, the treatment's ability to lead to genetic parenthood did not affect the treatment preference of patients with severe infertility (n = 173). Genetic parenthood affected the treatment preference of gynaecologists (n = 111) less than all other treatment characteristics. Patients indicated that they would switch to a treatment that did not enable genetic parenthood in return for a child health risk reduction of 3.6%, a cost reduction of €3500, an ovarian hyperstimulation risk reduction of 4.6%, a maternal cancer risk reduction of 2.7% or a pregnancy rate increase of 18%. Gynaecologists made similar trade-offs. CONCLUSIONS: While awaiting replication of this study in larger populations, these findings challenge the presumed dominant importance of genetic parenthood. This raises questions about whether donor gametes could be presented as a worthy alternative earlier in treatment trajectories and whether investments in novel treatments enabling genetic parenthood, like in-vitro gametogenesis, are proportional to their future clinical effect.

Cost-effectiveness of ovarian stimulation with gonadotrophin and clomiphene citrate in an intrauterine insemination programme for subfertile couples.

Ovarian stimulation with low-dose human menopausal gonadotrophin (HMG) is superior to clomiphene citrate in intrauterine insemination (IUI) cycles with respect to clinical pregnancy rate, but it is unclear whether HMG is also the more cost-effective option. The aim of this study was to compare the cost-effectiveness of ovarian stimulation with low-dose subcutaneously administred HMG (37.5-75 IU per day) to orally administred clomiphene citrate (50 mg/day from day 3-7) in an IUI programme for subfertile couples. A cost-effectiveness analysis was conducted using the results of a randomized trial, including 620 IUI cycles. The primary outcome was the incremental cost-effectiveness ratio (ICER) of using HMG versus clomiphene citrate. Results are presented from the healthcare payer perspective. The total cost per patient associated with one IUI treatment with HMG is €764, whereas it is €558 if clomiphene citrate is used, resulting in an incremental cost of €206 for HMG per treatment. The incremental clinical pregnancy rate of using HMG instead of clomiphene citrate, however, is also 5.7 percentage points higher, resulting in an ICER of HMG versus clomiphene citrate of €3615 per additional clinical pregnancy achieved. On average, HMG was found to be more cost-effective than clomiphene citrate.

The association between experiences with patient-centred care and health-related quality of life in women with endometriosis.

In this cross-sectional study, we investigated whether patient-centred endometriosis care (PCEC) is associated with health-related quality of life (HRQOL). Dutch-speaking women with endometriosis, treated by laparoscopy in a university clinic between 2009 and 2010, were eligible (n = 194). Endometriosis Health Profile-30 and ENDOCARE questionnaire were used to assess HRQOL and PCEC, respectively. Overall and subscale scores were converted to a scale from 0 (best score) to 100 (worst score). Linear regression analyses were conducted while controlling for confounders. Participants (n = 109) had a mean age of 35.4 years; 79.6% had moderate-severe endometriosis. Mean scores for overall HRQOL and PCEC were 29.3/100 and 38.0/100, respectively. The PCEC-subscale 'continuity' was significantly associated with overall HRQOL (P = 0.029). A significant association was found between overall PCEC and the HRQOL-subscale 'social support' (P = 0.026). The PCEC-subscales 'information' and 'continuity' were significantly associated with the HRQOL-subscales 'emotional wellbeing' and 'social support' (P < 0.05). The PCEC-subscale 'respect' was significantly associated with the HRQOL-subscale 'emotional wellbeing' (P = 0.023). Multivariable regression analyses produced no significant associations, including all subscales of PCEC. Providing PCEC could lead to better HRQOL, especially if paying attention to 'continuity', 'respect' and 'information'. Large-scale longitudinal research is needed.

Detecting Endometriosis in Adolescents: Why Not Start from Self-Report Screening Questionnaires for Adult Women?

BACKGROUND: Endometriosis in adolescent girls is often diagnosed after a long delay. This diagnostic delay can be associated with more advanced stages of endometriosis and with a higher likelihood of fertility problems at a later age. MATERIAL AND METHODS: A systematic review of literature and quality assessment was performed in order to identify questionnaires that were developed to identify adult women with endometriosis. Based on these questionnaires, specific questions that had been reported to be predictive for endometriosis were selected and included in a newly composed questionnaire with the aim to identify adolescents at risk of developing endometriosis. RESULTS: Based on the literature, we identified 5 questionnaires developed to identify adult women with endometriosis; this questionnaire contained 6 questions that had been reported to be predictive for adult endometriosis. These questions query age of menarche, cycle duration, dysmenorrhea, pain descriptors, dyschezia and urinary symptoms and were combined into a new self-report questionnaire aimed to identify adolescents at risk to develop endometriosis. CONCLUSION: We developed a self-report questionnaire aimed to identify adolescents at risk to develop endometriosis based on questions from self-report questionnaires that have been reported to identify adult women with endometriosis.

Perceptions of oocyte banking from women intending to circumvent age-related fertility decline.

INTRODUCTION: Women can now opt to bank their oocytes with the intention of increasing their chances of achieving a pregnancy after their fertility has declined. This exploratory study aimed to gain insight into how women, considering oocyte banking to circumvent age-related fertility decline, perceive this intervention. MATERIAL AND METHODS: We conducted a qualitative study in a Dutch university medical center and held in-depth interviews with women on the waiting list for oocyte banking. We recorded the interviews, transcribed them verbatim and used thematic analysis. RESULTS: All women were financially independent and lived in single-person urban households. They opted for oocyte banking because they wished to share parenthood with a future partner rather than becoming a single parent. This strong desire was key in their interpretation of all aspects of the intervention. Women set aside information about the limited success rates and potential risks, as they were optimistic about their own prognosis, thought that the chances for success were equally likely as the chances it would fail, and because of "anticipatory regret". They perceived oocyte banking as a "helping hand" to achieve shared parenthood. Although women found the costs of the intervention high, they were willing to invest their money to increase their chances for shared parenthood. CONCLUSIONS: Oocyte banking allows women to circumvent age-related fertility decline. The prospect of potential shared parenthood overrules the perceived health risks and burden. Health professionals should take this into account when informing potential users of oocyte banking.

How to reform western care payment systems according to physicians, policy makers, healthcare executives and researchers: a discrete choice experiment.

BACKGROUND: Many developed countries are reforming healthcare payment systems in order to limit costs and improve clinical outcomes. Knowledge on how different groups of professional stakeholders trade off the merits and downsides of healthcare payment systems is limited. METHODS: Using a discrete choice experiment we asked a sample of physicians, policy makers, healthcare executives and researchers from Canada, Europe, Oceania, and the United States to choose between profiles of hypothetical outcomes on eleven healthcare performance objectives which may arise from a healthcare payment system reform. We used a Bayesian D-optimal design with partial profiles, which enables studying a large number of attributes, i.e. the eleven performance objectives, in the experiment. RESULTS: Our findings suggest that (a) moving from current payment systems to a value-based system is supported by physicians, despite an income trade-off, if effectiveness and long term cost containment improve. (b) Physicians would gain in terms of overall objective fulfillment in Eastern Europe and the US, but not in Canada, Oceania and Western Europe. Finally, (c) such payment reform more closely aligns the overall fulfillment of objectives between stakeholders such as physicians versus healthcare executives. CONCLUSIONS: Although the findings should be interpreted with caution due to the potential selection effects of participants, it seems that the value driven nature of newly proposed and/or introduced care payment reforms is more closely aligned with what stakeholders favor in some health systems, but not in others. Future studies, including the use of random samples, should examine the contextual factors that explain such differences in values and buy-in. JEL CLASSIFICATION: C90, C99, E61, I11, I18, O57.

The patient-centeredness of endometriosis care and targets for improvement: a systematic review.

BACKGROUND: Endometriosis is a prevalent condition compromising physical and psychosocial health and thus requiring patient-centered care, which is guided by patients' values. This study aimed to find out what the patient's perspective on endometriosis care is and how the patient-centeredness of endometriosis care can be improved. METHODS: Electronic databases were searched systematically, and study selection was based on eligibility and quality. Study methodology was examined. Specific care aspects valued by patients were organized according to 10 dimensions of patient-centered endometriosis care. Based on patients' assessments of service quality, patient-centered improvement targets and strengths were identified. RESULTS: Twelve of 20 eligible studies had sufficient quality to be included. Endometriosis patients valued all 10 dimensions of patient-centered endometriosis care. Problematic service quality was reported for all dimensions but 'coordination and integration' and 'involvement of significant others'. Two patient-centered strengths and 29 patient-centered improvement targets were identified. The most frequently reported improvement targets on which studies agreed were 'timely diagnosis' and 'being believed and respected by staff'. CONCLUSION: Endometriosis patients value patient-centeredness in addition to effectiveness and safety of care, and its 10 dimensions require attention in clinical practice. Research into the assessment and improvement of patient-centered endometriosis care is required.

Patients' preferences for gonadotrophin-releasing hormone analogs in in vitro fertilization.

BACKGROUND: Gonadotrophin-releasing hormone (GnRH) antagonists reduce ovarian hyperstimulation syndrome (OHSS) at the price of a small reduction in effectiveness compared to GnRH agonists. The aim of this study was to investigate patients' preferences on effectiveness, safety and burden of GnRH analogs. METHODS: A discrete choice experiment (DCE) and a trade-off question were designed. Patients embarking on assisted reproductive technique treatment were asked to choose between two hypothetical medications which differed in effectiveness, safety and burden. RESULTS: A total of 172 questionnaires were analyzed. All attributes of the DCE had a statistically significant impact on the preference of the respondents. Respondents were willing to trade off 0.87 and 0.81% effectiveness for a decrease in OHSS risk and for fewer side effects, respectively. Respondents were not willing to trade off effectiveness for 'importance of compliance' (trade-off 0.40%) or a shorter 'duration of treatment' (trade-off 0.26%). The trade-off questions showed that already at a 2.0% increase in pregnancy rate in favor of the agonists, the majority of the respondents changed their preference from antagonists to agonists (2.0%, 95% CI 1.7-2.1). CONCLUSION: Safety and burden are important to patients, but are not important enough to make up for a small decrease in pregnancy rate.

A blended preconception lifestyle programme for couples undergoing IVF: lessons learned from a multicentre randomized controlled trial.

STUDY QUESTION: What is the effect of a blended preconception lifestyle programme on reproductive and lifestyle outcomes of couples going through their first 12 months of IVF as compared to an attention control condition? SUMMARY ANSWER: This randomized controlled trial (RCT) was stopped prematurely because of the coronavirus disease 2019 (Covid-19) pandemic but the available data did not suggest that a blended preconception lifestyle programme could meaningfully affect time to ongoing pregnancy or other reproductive and lifestyle outcomes. WHAT IS KNOWN ALREADY: Increasing evidence shows associations between a healthy lifestyle and IVF success rates. Lifestyle programmes provided through a mobile phone application have yet to be evaluated by RCTs in couples undergoing IVF. STUDY DESIGN SIZE DURATION: A multicentre RCT (1:1) was carried out. The RCT started in January 2019 and was prematurely stopped because of the Covid-19 pandemic, leading to a reduced sample size (211 couples initiating IVF) and change in primary outcome (cumulative ongoing pregnancy to time to ongoing pregnancy). PARTICIPANTS/MATERIALS SETTING METHODS: Heterosexual couples initiating IVF in five fertility clinics were randomized between an attention control arm and an intervention arm for 12 months. The attention control arm received treatment information by mobile phone in addition to standard care. The intervention arm received the blended preconception lifestyle (PreLiFe)-programme in addition to standard care. The PreLiFe-programme included a mobile application, offering tailored advice and skills training on diet, physical activity and mindfulness, in combination with motivational interviewing over the telephone. The primary outcome was 'time to ongoing pregnancy'. Secondary reproductive outcomes included the Core Outcome Measures for Infertility Trials and IVF discontinuation. Changes in the following secondary lifestyle outcomes over 3 and 6 months were studied in both partners: diet quality, fruit intake, vegetable intake, total moderate to vigorous physical activity, sedentary behaviour, emotional distress, quality of life, BMI, and waist circumference. Finally, in the intervention arm, acceptability of the programme was evaluated and actual use of the mobile application part of the programme was tracked. Analysis was according to intention to treat. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 211 couples were randomized (105 control arm, 106 intervention arm). The hazard ratio of the intervention for time to ongoing pregnancy was 0.94 (95% CI 0.63 to 1.4). Little to no effect on other reproductive or lifestyle outcomes was identified. Although acceptability of the programme was good (6/10), considerable proportions of men (38%) and 9% of women did not actively use all the modules of the mobile application (diet, physical activity, or mindfulness). LIMITATIONS REASONS FOR CAUTION: The findings of this RCT should be considered exploratory, as the Covid-19 pandemic limited its power and the actual use of the mobile application was low. WIDER IMPLICATIONS OF THE FINDINGS: This is the first multicentre RCT evaluating the effect of a blended preconception lifestyle programme for women and their partners undergoing IVF on both reproductive and lifestyle outcomes. This exploratory RCT highlights the need for further studies into optimal intervention characteristics and actual use of preconception lifestyle programmes, as well as RCTs evaluating effectiveness. STUDY FUNDING/COMPETING INTERESTS: Supported by the Research foundation Flanders (Belgium) (FWO-TBM; reference: T005417N). No competing interests to declare. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT03790449. TRIAL REGISTRATION DATE: 31 December 2018. DATE OF FIRST PATIENT'S ENROLMENT: 2 January 2019.

Patient evaluation of infertility management in an ISO 9001:2008-certified centre for reproductive medicine.

Quality management according to ISO 9001:2008 guidelines includes infertility care quality assessment and improvement. This study aimed to describe the development process of a questionnaire for infertility management. A literature review, qualitative interviews with experts and patients resulted in a content-valid and face-valid questionnaire. Three cross-sectional surveys were performed in 2004, 2007 and 2008 in a tertiary university infertility centre. First (2004), the questionnaire ­ measuring eight a-priori dimensions of infertility management ­ was tested. Second (2007), improvement projects for infertility management were evaluated. Third (2008), factor analysis was performed and internal consistency was documented. The developed patient questionnaire to evaluate infertility management and pre-set desired levels of agreement served to set targets for and assess quality improvement projects. The final patient questionnaire to evaluate infertility management within an ISO framework was valid and reliable and contained 14 items covering four dimensions of infertility management: Telephone Access, Reception, Information and Patient-centeredness. ISO 9001:2008-certified infertility centres can evaluate infertility management with this 14-item questionnaire. This top-down approach to evaluate the patients' perspective on quality aspects selected by health professionals can be complementary to the bottom-up approach evaluating the patients' complete experiences of quality of care.

Evaluation of a stand-alone mobile mindfulness app in people experiencing infertility: the protocol for an exploratory randomised controlled trial (MoMiFer-RCT).

INTRODUCTION: Infertility and its treatment bring a considerable emotional burden. Increasing evidence demonstrates the effectiveness of smartphone-delivered mindfulness apps for reducing symptoms of emotional distress in both clinical and non-clinical populations. Evidence on this topic in women, men and couples experiencing infertility is currently under-represented. The aim of the MoMiFer study is, therefore, to investigate the efficacy of a stand-alone mobile mindfulness app on symptoms of emotional distress and fertility-related quality of life in people experiencing infertility. METHODS AND ANALYSIS: This study is an exploratory randomised controlled trial (RCT) with open enrollment. The primary outcomes are symptoms of emotional distress and fertility-related quality of life. Secondary outcomes are mindfulness skills, repetitive negative thinking, self-compassion, user-rated quality of the stand-alone mobile mindfulness app and use of the app. Experience sampling method and standardised self-report questionnaires are combined within a repeated measures design to measure the effects of the stand-alone mobile mindfulness app on the primary and secondary outcomes, apart from the use of the app. The latter will be evaluated through app tracking. People, including women, men and couples, experiencing infertility (n=60) will be randomised to an intervention group receiving the stand-alone mobile mindfulness app for 3 months or a wait-list control group. The app follows the format and content of Mindfulness-Based Stress Reduction. Data will be collected at baseline, at 1.5 months and 3 months after randomisation. Analysis will be according to intention to treat and based on general linear modelling and multilevel mixed-effects modelling. ETHICS AND DISSEMINATION: This study received approval from the Medical Ethical Committee of the Leuven University Hospital (Belgium). The findings of this exploratory RCT will be disseminated through presentations at public lectures, scientific institutions and meetings, and through peer-reviewed scientific articles. TRIAL REGISTRATION NUMBER: NCT04143828.

Good practice recommendations for information provision for those involved in reproductive donation†.

STUDY QUESTION: What information and support should be offered to donors, intended parents and donor-conceived people, in general and in consideration of the availability of direct-to-consumer genetic testing and matching services? SUMMARY ANSWER: For donors, intended parents and donor-conceived offspring, recommendations are made that cover information needs and informed consent, psychosocial implications and disclosure. WHAT IS KNOWN ALREADY: Trends indicate that the use of donor-assisted conception is growing and guidance is needed to help these recipients/intended parents, the donors and offspring, navigate the rapidly changing environment in which donor-assisted conception takes place. STUDY DESIGN SIZE DURATION: A working group (WG) collaborated on writing recommendations based, where available, on evidence collected from a literature search and expert opinion. Draft recommendations were published for stakeholder review and adapted where relevant based on the comments received. PARTICIPANTS/MATERIALS SETTING METHODS: Papers retrieved from PUBMED were included from 1 January 2014 up to 31 August 2020, focusing on studies published since direct-to-consumer genetic testing has become more widespread and accessible. The current paper is limited to reproductive donation performed in medically assisted reproduction (MAR) centres (and gamete banks): donation outside the medical context was not considered. MAIN RESULTS AND THE ROLE OF CHANCE: In total, 32 recommendations were made for information provision and support to donors, 32 for intended parents and 27 for donor-conceived offspring requesting information/support. LIMITATIONS REASONS FOR CAUTION: The available evidence in the area of reproductive donation is limited and diverse with regards to the context and types of donation. General conclusions and recommendations are largely based on expert opinion and may need to be adapted in light of future research. WIDER IMPLICATIONS OF THE FINDINGS: These recommendations provide guidance to MAR centres and gamete banks on good practice in information provision and support but should also be considered by regulatory bodies and policymakers at a national and international level to guide regulatory and legislative efforts towards the protection of donors and donor-conceived offspring. STUDY FUNDING/COMPETING INTERESTS: The development of this good practice paper was funded by European Society of Human Reproduction and Embryology (ESHRE), covering expenses associated with the WG meetings, the literature searches and dissemination. The WG members did not receive any payment. The authors have no conflicts of interest to declare. DISCLAIMER: This document represents the views of ESHRE, which are the result of consensus between the relevant ESHRE stakeholders and where relevant based on the scientific evidence available at the time of preparation. The recommendations should be used for informational and educational purposes. They should not be interpreted as setting a standard of care, or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. They do not replace the need for application of clinical judgement to each individual presentation, nor variations based on locality and facility type. †ESHRE pages content is not externally peer reviewed. The manuscript has been approved by the Executive Committee of ESHRE.