Reproductive and obstetrical outcomes after treatment of retained products of conception: hysteroscopic removal vs ultrasound-guided electric vacuum aspiration, a prospective follow-up study.

BACKGROUND: Traditionally, curettage has been the most widely performed surgical intervention for removing retained products of conception. However, hysteroscopic removal is increasingly performed as an alternative because of the potentially lower risk of intrauterine adhesions and higher rates of complete removal. Until recently, studies comparing curettage with hysteroscopic removal regarding reproductive and obstetrical outcomes were limited, and data conflicting. OBJECTIVE: This study aimed to assess reproductive and obstetrical outcomes in women wishing to conceive after removal of retained products of conception by hysteroscopy or ultrasound-guided electric vacuum aspiration. STUDY DESIGN: This was a prospective long-term follow-up study, conducted in 3 teaching hospitals and 1 university hospital. Patients were included from April 2015 until June 2022 for follow-up, either in a randomized controlled, nonblinded trial on the risk of intrauterine adhesions after removal of retained products of conception, or in a cohort alongside the randomized trial. Women with an ultrasonographic image suggestive of retained products of conception ranging from 1 to 4 cm were eligible. Surgical procedures in the randomized controlled trial were hysteroscopic morcellation or ultrasound-guided electric vacuum aspiration. In the cohort study, hysteroscopic treatment included hysteroscopic morcellation or cold loop resection compared with ultrasound-guided electric vacuum aspiration. RESULTS: A total of 261 out of 305 patients (85.6%) were available for follow-up after removal of retained products of conception, resulting in a cohort of 171 women after hysteroscopic removal and 90 women after removal by ultrasound-guided vacuum aspiration. Respectively, 92 of 171 women (53.8%) in the hysteroscopic removal group and 56 of 90 (62.2%) in the electric vacuum aspiration group wished to conceive (P=.192). Subsequent pregnancy rates were 88 of 91 (96.7%) after hysteroscopic removal and 52 of 56 (92.9%) after electric vacuum aspiration (P=.428). The live birth rates were 61 of 80 (76.3%) and 37 of 48 (77.1%) after hysteroscopic removal and electric vacuum aspiration, respectively (P=.914), with 8 of 88 pregnancies (9.1%) in the hysteroscopic removal group and 4 of 52 (7.7%) in the electric vacuum aspiration group still ongoing at follow-up (P=1.00). The median time to conception was 8.2 weeks (interquartile range, 5.0-17.2) in the hysteroscopic removal group and 6.9 weeks (interquartile range, 5.0-12.1) in the electric vacuum aspiration group (P=.262). The overall placental complication rate was 13 of 80 (16.3%) in the hysteroscopic removal group and 11 of 48 (22.9%) in the electric vacuum aspiration group (P=.350). CONCLUSION: Hysteroscopic removal and ultrasound-guided electric vacuum aspiration of retained products of conception seem to have no significantly different effects on subsequent live birth rate, pregnancy rate, time to conception, or pregnancy complications. Reproductive and obstetrical outcomes after removal of retained products of conception are reassuring, albeit with a high risk of placental complications.

The ADENO study: ADenomyosis and its Effect on Neonatal and Obstetric outcomes: a retrospective population-based study.

BACKGROUND: Adenomyosis is a benign gynecologic condition arising from the uterine junctional zone. Recent studies suggest a relationship between adenomyosis and adverse obstetrical outcomes, but evidence remains conflicting. There is no large-scale study investigating obstetrical outcomes in women with adenomyosis using the gold standard of histopathologic diagnosis. OBJECTIVE: This study aimed to investigate the prevalence of adverse obstetrical and neonatal outcomes in women with histopathologic adenomyosis and that of the general (Dutch) population. STUDY DESIGN: This retrospective population-based study used 2 Dutch national databases (Perined, the perinatal registry, and the nationwide pathology databank [Pathologisch Anatomisch Landelijk Geautomiseerd Archief], from 1995 to 2018) to compare obstetrical outcomes in women before histopathologic adenomyosis diagnosis to the general Dutch population without registered histopathologic adenomyosis. The adjusted odds ratios (95% confidence interval) were calculated for adverse obstetrical outcomes. The outcomes were adjusted for maternal age, parity, ethnicity, year of registered birth, induction of labor, hypertensive disorders in previous pregnancies, multiple gestation, and low socioeconomic status. RESULTS: The pregnancy outcomes of 7925 women with histopathologic adenomyosis were compared with that of 4,615,803 women without registered adenomyosis. When adjusted for confounders, women with adenomyosis had adjusted odds ratios of 1.37 (95% confidence interval, 1.25-1.50) for hypertensive disorders, 1.37 (95% confidence interval, 1.25-1.51) for preeclampsia, 1.15 (95% confidence interval, 1.07-1.25) for small-for-gestational-age infants, 1.54 (95% confidence interval, 1.41-1.68) for emergency cesarean delivery, 1.24 (95% confidence interval, 1.12-1.37) for failure to progress, 1.29 (95% confidence interval, 1.10-1.48) for placental retention, and 1.23 (95% confidence interval, 1.10-1.38) for postpartum hemorrhage. No increased risk of HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome, placental abruption, or operative vaginal delivery or need for oxytocin stimulation was found. CONCLUSION: Women with a histopathologic diagnosis of adenomyosis showed an increased prevalence of hypertensive disorders of pregnancy and small-for-gestational-age infants, failure to progress in labor, and placental retention compared with the general population in previous pregnancies. This suggests that uterine (contractile) function in labor and during pregnancy is impaired in women with adenomyosis.

Uterine contractile activity in healthy women throughout the menstrual cycle measured using a novel quantitative two-dimensional transvaginal ultrasound speckle tracking method.

RESEARCH QUESTION: To explore normal uterine contractile function across the menstrual cycle using a novel quantitative ultrasound method. DESIGN: This multicentre prospective observational study took place in three European centres from 2014 to 2022. Uterine contraction frequency (contractions/minute), amplitude, direction (cervix-to-fundus, C2F; fundus-to-cervix; F2C), velocity and coordination were investigated. Features were extracted from transvaginal ultrasound recordings (TVUS) using speckle tracking. Premenopausal women ≥18 years of age, with normal, natural menstrual cycles were included. A normal cycle was defined as: regular (duration 28 ± 2 days), no dysmenorrhoea, no menometrorrhagia. Four-minute TVUS were performed during the menstrual phase, mid-follicular, late follicular phase, early luteal phase and/or late luteal phase. Of the 96 recordings available from 64 women, 70 were suitable for inclusion in the analysis. RESULTS: Contraction frequency (for the posterior wall) and velocity (for the anterior uterine wall in the F2C direction) were highest in the late follicular phase and lowest in the menstrual and late luteal phases (1.61 versus 1.31 and 1.35 contractions/min, P < 0.001 and 0.81 versus 0.67 and 0.62 mm/s, P < 0.001, respectively). No significant difference was found for contraction amplitude. Contraction coordination (simultaneous contraction of the anterior and posterior walls in the same direction) was least coordinated in the mid-follicular phase (P = 0.002). CONCLUSIONS: This is the first study to objectively measure uterine contraction features in healthy women during the natural menstrual cycle on TVUS. Likewise, it introduces contraction coordination as a specific feature of uterine peristalsis. Differences in uterine contractility across the menstrual cycle are confirmed, with highest activity seen in the late follicular phase, and lowest in the late luteal phase.

Fertility Workup With Video Consultation During the COVID-19 Pandemic: Pilot Quantitative and Qualitative Study.

BACKGROUND: Due to the COVID-19 pandemic, major parts of elective health care in the Netherlands, such as reproductive medicine, were paused. When health care was resumed, video consultation was used as a new solution to continue consultations with the new governmental rules of social distancing. Prior to this COVID-19 situation, video consultation was not used extensively in the Netherlands; therefore, physicians and patients are not familiar with this way of consultation. OBJECTIVE: The purpose of this study was to measure the level of patient centeredness and shared decision making in infertile couples who have undergone fertility workup through video consultation. METHODS: This is a questionnaire study with an additional qualitative part for a more in depth understanding. Infertile couples (ie, male and female partners with an unfulfilled wish for a child after 1 year of unprotected intercourse) were referred to a fertility center and underwent fertility workup through video consultation. The fertility workup consisted of 2 separate video consultations, with diagnostic tests according to a protocol. After the last video consultation couples received a digital questionnaire, which consisted of a modified version of the Patient-Centered Questionnaire-Infertility (PCQ-I) and CollaboRATE questionnaire. Fifty-three eligible infertile couples were approached, and of these, 22 participated. Four women were approached for a semistructured interview. RESULTS: The median score on the modified PCQ-I (scale of 0 to 3) was 2.64. The highest rating was for the subscale communication and information, and the lowest rating was for the subscale organization of care. The median score on the CollaboRATE questionnaire (scale of 1 to 9) was 8 for all 3 subquestions. Patients mentioned privacy, less travel time, and easy use of the program as possible benefits of video consultation. However, patients preferred the first consultation with their physician to be face-to-face consultation as video consultation was considered less personal. CONCLUSIONS: The high levels of patient centeredness and shared decision making show that video consultation is a promising way of providing care remotely, although attention has to be payed to mitigate the more impersonal setting of video consultation when compared with face-to-face consultation.

Independent and Web-Based Advice for Infertile Patients Using Fertility Consult: Pilot Study.

BACKGROUND: Patient-centered care-that is, care tailored to personal wishes and needs of patients-has become increasingly important. It is especially relevant in health care areas where patients suffer from a high burden of disease, such as fertility care. At present, both diagnosis and treatment for infertile couples is provided at a single hospital. As a consequence, patients are not likely to receive optimal, independent advice regarding their fertility problems. Internet-based, independent advice could be feasible for large groups of patients because it is not limited by travel distance and overhead costs. OBJECTIVE: The aim of this study was to explore the experiences of both patients and professionals with an online platform using video consultations for patients with infertility seeking independent advice for their fertility problem. METHODS: This pilot study evaluated an online platform, Fertility Consult, where patients with infertility can get independent advice by a gynecologist through a video consultation, thus eliminating the need of meeting the doctor physically. Semistructured interviews were performed with 2 gynecologists and the chairman of the Dutch patients association. This information was used for a patients' questionnaire about their first experiences with Fertility Consult, including questions about the level of patient-centeredness and shared decision making, using the Patient-Centered Questionnaire-Infertility (PCQ-Infertility) and the CollaboRATE questionnaire, respectively. RESULTS: Of the first 27 patients enrolled at Fertility Consult, 22 responded (82%). Most patients (82%) visited Fertility Consult for a second opinion, seeking more personal attention and independent advice. The mean level of patient-centeredness on the PCQ-Infertility questionnaire was 2.78 (SD 0.58) on a scale of 0 to 3. For the CollaboRATE questionnaire (scale 0-9), patients provided a median score of 8.0 (range 7-9) on all 3 questions about shared decision making. CONCLUSIONS: Patients were satisfied with independent, well-prepared, Web-based advice; health care professionals felt they were able to provide patients with proper advice in a manner befitting patients' needs, without any loss of quality. Future studies should focus more on the separation of advice and treatment and on Web-based consultations compared with face-to-face consultations to ascertain the possibility of increased patient involvement in the process to improve the level of patient-centered care.

Laparoscopic Sterilization Under Local Anesthesia with Conscious Sedation Versus General Anesthesia: Systematic Review of the Literature.

Female sterilization is the most popular and common contraceptive method worldwide. Because hysteroscopic sterilization techniques are used less often due to side effects, the number of laparoscopic sterilization is increasing. A systematic overview concerning the most optimal anesthetic technique for laparoscopic sterilization is lacking. We performed a systematic review to compare conscious sedation with general anesthesia for laparoscopic sterilization procedures with respect to clinical relevant outcome measures, such as operating times, perioperative parameters and complications, patient comfort, recovery, and patient satisfaction. We searched Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE for randomized controlled trials comparing general anesthesia with conscious sedation for laparoscopic sterilization. Two authors (AGH and HAAMvV) abstracted and entered data into RevMan. Methodologic quality of the included trials was critically appraised. For our main outcome measures mean differences (continuous variables) and risk ratios (dichotomous variables) with 95% confidence intervals using random-effect models were calculated. Four randomized controlled trials were included comparing general anesthesia versus local anesthesia with conscious sedation for laparoscopic sterilization. The methodologic quality of the studies was moderate to good. Both techniques were comparable with regard to operating times, complications, and postoperative pain. However, local anesthesia with conscious sedation showed better results compared with general anesthesia with respect to recovery times, patient complaints of sore throat, and patient recovery and satisfaction. In conclusion, this systematic review about anesthetic techniques for laparoscopic sterilization showed that both general anesthesia and conscious sedation have no major anesthetic complications and may therefore be safe. Patients might benefit from conscious sedation in terms of recovery times, sore throat, and patient recovery and satisfaction, but only a few studies are included in the review and are relatively old. New research regarding this subject is needed to advise our patients most optimally in the future about the best anesthetic technique to be used when choosing for a laparoscopic sterilization procedure.

Improving patient-centredness in partnership with female patients: a cluster RCT in fertility care.

QUESTION: What is the effect of a multifaceted intervention with participation of patients on improvement of patient-centredness in fertility care? SUMMARY ANSWER: A multifaceted intervention with participation of patients did not improve total patient-centredness scores provided by women in fertility care. WHAT IS KNOWN ALREADY: We should provide care that takes into account the preferences and needs of patients, i.e. patient-centred care. Especially infertile patients who suffer from a high emotional burden of treatment could benefit from a more patient-centred approach in healthcare. However, the improvement of patient-centred care is still needed, because effective strategies to come to improvement are lacking. STUDY DESIGN, SIZE AND DURATION: A cluster RCT was performed within 32 Dutch fertility clinics, covering about one-third of all Dutch hospitals. After randomization, 16 clinics in the intervention group were exposed to a multifaceted improvement strategy for patient-centred fertility care for 1 year. This strategy comprised audit and feedback, educational outreach visits and patient-mediated interventions. The remaining 16 clinics in the control group performed care as usual. PARTICIPANTS/MATERIALS, SETTING AND METHODS: The clinics' levels of patient-centredness were measured, using the validated Patient-centredness Questionnaire-Infertility (PCQ-Infertility). At baseline measurement, a total of 1620 women in couples undergoing fertility care (this included both male, female, mixed infertility and infertility of unknown cause) in one of the participating clinics were randomly selected to participate in the study and complete the questionnaire. For the after measurement, we randomly selected a comparable sample of 1565 women in infertile couples. Both women who had already started their treatment before the start of the study (67%) and women who started their treatment after the start of this study (33%) were included. To avoid bias, we only included the responses of non-pregnant respondents. MAIN RESULTS AND ROLE OF CHANCE: The final analysis involved 30 clinics. A total of 946 women (response 58.4%) completed their questionnaire at baseline measurement and also a total of 946 women (response 60.4%) at after measurement. After excluding the pregnant patients, respectively 696 and 730 questionnaires were eligible for analysis at baseline and after measurement. The total score of case-mix adjusted PCQ-Infertility at after measurement did not differ significantly between the intervention and control group (B = 0.06; 95% confidence interval (CI) = -0.04-0.15; P = 0.25). However, scores on the continuity of care subscale were significantly higher in the intervention group compared with the control group (B = 0.20; 95% CI = 0.00-0.40; P < 0.05). The addition of three interaction terms to the model had a significant impact: (i) being younger than 36 years, (ii) beginning treatment after the study had started and (iii) using complementary and alternative medicine. If women met all three conditions, the scores in the intervention group were on average 0.31 points higher compared with the control group (95% CI = 0.14-0.48; P = <0.001). LIMITATIONS, REASONS FOR CAUTION: Our response rates are sufficient, but the responses of many women are still lacking which might have biased our results. Furthermore, the PCQ-Infertility scores at baseline measurement were already reasonably high, which could have limited the effect of the multifaceted improvement strategy. Because we only included women in infertile couples in our study, we cannot draw conclusions on the effect of an improvement strategy for patient-centred fertility care for partners. WIDER IMPLICATION OF THE FINDINGS: A multifaceted intervention with participation of patients did not improve total patient-centredness scores, although some effect could be observed in specific groups of women and in specific dimensions of patient-centredness. These results can guide future research, in which we should focus more on personalized strategies and outcome measures. STUDY FUNDING/COMPETING INTERESTS: This work was supported by Merck Sharp & Dohme (MSD), The Netherlands. There are no competing interests. TRIAL REGISTRATION: Clinical Trials NCT01481064.

Psychosocial and demographic correlates of the discontinuation of in vitro fertilization.

In this study, we investigated the relationship between psychosocial factors assessed pre-treatment and the discontinuation of in vitro fertilisation (IVF) treatment after one year. A cohort study was performed in a Dutch fertility clinic and included 667 couples. Demographic characteristics, scores for psychosocial factors, discontinuation rates, reasons for discontinuation and outcome data of the treatment were measured. Discontinuation due to personal reasons was differentiated from discontinuation because of changing a clinic or physicians' advice. The results showed that 37.5% of the couples became pregnant, while 40 (6%) discontinued IVF treatment because of personal reasons. A sample size of 288 women remained for analysis. A longer duration of infertility, less perceived social support in women and higher scores on acceptance of infertility in both men and women were significantly correlated with discontinuation. Multivariate analysis, using these variables including the age of the women, showed that these factors could explain 29% of the discontinuation. These results point to a differentiation between couples who choose positively choose to discontinue treatment and those discontinuing from a more negative perspective. Opportunities to tailor interventions to this second group of couples need to be investigated.

The monetary value of patient-centred care: results from a discrete choice experiment in Dutch fertility care.

STUDY QUESTION: What are patients and insurers willing to pay for different aspects of fertility care, with a particular focus on patient-centredness? SUMMARY ANSWER: In fertility care, both patients and health insurers place a high value on patient-centred factors, also when taking into account the effectiveness of fertility care. WHAT IS KNOWN ALREADY?: The benefit patients derive from fertility treatment may arise from several aspects of their care, such as the effectiveness, safety or patient-centred factors. Patient-centredness is recognized as an important, multi-dimensional concept, including domains on the organizational level (e.g. information provision) and on the human level (e.g. patient involvement). STUDY DESIGN, SIZE, AND DURATION: We performed a discrete choice experiment (DCE) within 32 Dutch fertility clinics and five large health insurance companies in the Netherlands. A total of 996 infertile patients who underwent at least one treatment cycle for their fertility problem and 84 healthcare insurers participated in the study which was executed in the summer of 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: All participating patients and health insurers completed a DCE about their preferences in fertility care regarding the effectiveness, patient-centredness of care and additional costs. Logistic regression analysis was subsequently used to determine what both patients and health insurers were willing to pay for a one-step increase in patient-centred care and 1% higher pregnancy rates. MAIN RESULTS AND THE ROLE OF CHANCE: Five hundred and fifty patients (55.2%) and 45 healthcare insurers (53.6%) completed the DCE questionnaire. Patients were willing to pay a median amount of €463 for a relevant one-step increase in patient-centred care and €107 for 1% increase in pregnancy rates. Healthcare insurers' valuations were lower: €191 for more patient-centred care and €60 for 1% increase in pregnancy rates. The willingness-to-pay values depended on patients' age, patients' ethnicity, income, and treatment type and on health insurers' age. LIMITATIONS, REASONS FOR CAUTION: An important limitation of a DCE study is that other attributes, that were not included in our study, are relevant as well. Therefore, our study participants might make other choices in real life compared with our hypothetical DCE scenarios. We tried to prevent this potential bias by selecting the most important attributes from the literature, using the input of an expert panel and performing a pilot study to test the validity of our questionnaire. WIDER IMPLICATIONS OF THE FINDINGS: This study emphasizes the importance of patient-centredness aspects of care for both infertile patients and their insurers. Therefore, efforts by policymakers and clinicians to improve these aspects of care would increase the overall value patients derive from their fertility treatment. Moreover, although insurers placed a lower monetary value on patient-centredness aspects than patients, it is arguable that insurers' purchasing decisions should be guided by patient rather than insurer preferences. Finally, given the relatively high monetary value patients place on patient-centred aspects of their fertility care, there may be a willingness to allow for some optional co-payments for this quality of care dimension. STUDY FUNDING/COMPETING INTERESTS: This work was supported by Merck Sharp and Dohme, the Netherlands. No competing interests declared. TRIAL REGISTRATION NUMBER: Clinical Trials NCT01834313.

Different ways of subcutaneous tissue and skin closure at cesarean section: a randomized clinical trial on the long-term cosmetic outcome.

OBJECTIVE: To study the effect of subcutaneous tissue closing and the effect of two different skin closure methods at cesarean section on long-term cosmetic results. DESIGN: Randomized controlled trial. SETTING: A large teaching hospital in the Netherlands. POPULATION: Women undergoing a cesarean section. METHODS: Women undergoing a cesarean section were assigned to subcutaneous tissue closure or not, and skin closure with staples or intracutaneous sutures. Operating time, postoperative pain and incidence of complications were recorded. Long-term cosmetic result was assessed 1 year postoperatively through the Patient and Observer Scar Assessment Scale (POSAS) and Numeric Rating Scale (NRS). MAIN OUTCOME MEASURES: The POSAS for subjective and objective scar rating and the NRS to provide an overall opinion on appearance of the scar 1 year after surgery. RESULTS: Of the 218 women randomized, data from 145 women could be analysed after 1 year of follow-up. No significant differences were detected in long-term cosmetic outcome between the different closure methods. Except for operating time, no differences in other secondary outcome measures were found. CONCLUSIONS: At cesarean section, closing the subcutaneous tissue or not and using staples or intracutaneous sutures results in an equivalent long-term cosmetic appearance of the scar.

Feedback to professionals on patient-centered fertility care is insufficient for improvement: a mixed-method study.

OBJECTIVE: To determine the effect of audits and feedback on the level of patient-centeredness in fertility care, and to obtain a more in-depth understanding of professionals' views on patient-centered care and achieving improvements. DESIGN: Mixed-method design, using semistructured in-depth interviews and patient questionnaires. SETTING: Fifteen Dutch fertility clinics. PATIENT(S): Women in infertility treatment (quantitative section) and fertility care professionals (qualitative section). INTERVENTION(S): Audit of the level of patient-centeredness of care, and feedback provided to clinics by a personalized paper-based feedback report. MAIN OUTCOME MEASURE(S): Quantitative section: the patient-reported differences in the level of patient-centered fertility care between 2009 and 2011 measured by the Patient-Centeredness Questionnaire-Infertility. Qualitative section: professionals views on improving patient-centered fertility care arranged into a Hibbard framework for behavioral change. RESULT(S): Multilevel regression analysis showed no statistically significant differences between the overall levels of patient-centeredness in 2009 and 2011. Qualitative research showed that professionals' urge to change and their ability to translate feedback were suboptimal to achieve behavioral change. CONCLUSION(S): Audits and feedback alone are not enough to improve the level of patient-centeredness in fertility care. Increasing professionals' desire to change and their ability to translate feedback about their performance into an optimal quality improvement strategy appear to be the key issues.

Do infertile women and their partners have equal experiences with fertility care?

OBJECTIVE: To study the possible differences between women and their partners' experiences with patient-centered fertility care. DESIGN: A cross-sectional study. SETTING: Thirty-two Dutch fertility clinics. PATIENT(S): A total of 1,620 infertile women and their partners, under treatment in one of the participating clinics, were randomly selected to participate in this study. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Level of patient-centeredness, measured with the validated Patient-Centeredness Questionnaire-Infertility questionnaire (PCQ-Infertility). RESULT(S): Questionnaires from 696 women and 520 partners were analyzed. No significant difference in PCQ-Infertility total score was found between women and their partners. The partners scored significantly higher on the subscales "respect for patients values" and "staff's competence" compared with the women. CONCLUSION(S): Patients' experiences with fertility care are only slightly different between women and their partners. This can be valuable in the process of improvement of patient-centered fertility care, one of the core dimensions of quality of care.

Improving patient-centeredness of fertility care using a multifaceted approach: study protocol for a randomized controlled trial.

BACKGROUND: Beside traditional outcomes of safety and (cost-)effectiveness, the Institute of Medicine states patient-centeredness as an independent outcome indicator to evaluate the quality of healthcare. Providing patient-centered care is important because patients want to be heard for their ideas and concerns. Healthcare areas associated with high emotions and intensive treatment periods could especially benefit from patient-centered care. How care can become optimally improved in patient-centeredness is unknown. Therefore, we will conduct a study in the context of Dutch fertility care to determine the effects of a multifaceted approach on patient-centeredness, patients' quality of life (QoL) and levels of distress. Our aims are to investigate the effectiveness of a multifaceted approach and to identify determinants of a change in the level of patient-centeredness, patients' QoL and distress levels. This paper presents the study protocol. METHODS/DESIGN: In a cluster-randomized trial in 32 Dutch fertility clinics the effects of a multifaceted approach will be determined on the level of patient-centeredness (Patient-centredness Questionnaire - Infertility), patients' QoL (FertiQoL) and levels of distress (SCREENIVF). The multifaceted approach includes audit and feedback, educational outreach visits and patient-mediated interventions. Potential determinants of a change in patient-centeredness, patients' QoL and levels of distress will be collected by an addendum to the patients' questionnaire and a professionals' questionnaire. The latter includes the Organizational Culture Assessment Instrument about the clinic's culture as a possible determinant of an increase in patient-centered care. DISCUSSION: The study is expected to yield important new evidence about the effects of a multifaceted approach on levels of patient-centeredness, patients' QoL and distress in fertility care. Furthermore, determinants associated with a change in these outcome measures will be studied. With knowledge of these results, patient-centered care and thus the quality of healthcare can be improved. Moreover, the results of this study could be useful for similar initiatives to improve the quality of care delivery. The results of this project are expected at the end of 2013. TRIAL REGISTRATION: Clinicialtrials.gov NCT01481064.