In vitro fertilization healthcare professionals generally underestimate patients' satisfaction with quality of care.

INTRODUCTION: Previous studies have mainly compared professionals' and patients' ratings of the importance of different care aspects, finding poor agreement between the groups concerning patient-centered quality of care. There is still little known about professionals' knowledge of how patients experience the quality of care they receive during in vitro fertilization (IVF) treatments. The aim of this study was to investigate how IVF healthcare professionals estimate patients' experience of patient-centered quality of care and if certain factors influenced the IVF professionals' perceptions and IVF patients' experience of quality of care. MATERIAL AND METHODS: All 16 IVF public and private clinics in Sweden participated in this cross-sectional study. A total of 268 IVF healthcare professionals and 3298 patients (women and men) undergoing IVF treatment between January and May 2015 participated by answering the validated questionnaire "Quality from the patients' perspective of in vitro fertilization treatment" (QPP-IVF). RESULTS: Healthcare professionals significantly underestimated patients' satisfaction with the patient-centered quality of care they received in all aspects measured. Both patients and professionals rated the most deficient factors to be "responsibility/continuity", "participation" and "availability". Healthcare professionals and patients belonging to private clinics evaluated patient-centered care as significantly better than professionals and patients at public clinics in almost all aspects measured. CONCLUSION: The results of this study will increase the professionals' understanding of the patients' experiences during IVF treatment and provide additional knowledge when identifying areas to prioritize to improve quality of care.

Noninferiority, randomized, controlled trial comparing embryo development using media developed for sequential or undisturbed culture in a time-lapse setup.

OBJECTIVE: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media. DESIGN: Randomized, double-blinded sibling trial. SETTING: Independent in vitro fertilization (IVF) clinics. PATIENT(S): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms. INTERVENTION(S): Embryos randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media. MAIN OUTCOME MEASURE(S): Percentage of good-quality blastocysts on day 5. RESULT(S): Percentage of day 5 good-quality blastocysts was 21.1% (standard deviation [SD] ± 21.6%) and 22.2% (SD ± 22.1%) in the single-step time-lapse medium (G-TL) and the sequential media (G-1/G-2) groups, respectively. The mean difference (-1.2; 95% CI, -6.0; 3.6) between the two media systems for the primary end point was less than the noninferiority margin of -8%. There was a statistically significantly lower number of good-quality embryos on day 3 in the G-TL group [50.7% (SD ± 30.6%) vs. 60.8% (SD ± 30.7%)]. Four out of the 11 measured morphokinetic parameters were statistically significantly different for the two media used. The mean levels of ammonium concentration in the media at the end of the culture period was statistically significantly lower in the G-TL group as compared with the G-2 group. CONCLUSION(S): We have shown that a single-step culture medium supports blastocyst development equivalently to established sequential media. The ammonium concentrations were lower in the single-step media, and the measured morphokinetic parameters were modified somewhat. CLINICAL TRIAL REGISTRATION NUMBER: NCT01939626.

Patient-centred quality of care in an IVF programme evaluated by men and women.

STUDY QUESTION: Do men and women value the same aspects of quality of care during IVF treatment when measuring rates of importance by the validated instrument, quality from the patient's perspective of in vitro fertilization (QPP-IVF)? SUMMARY ANSWER: Women valued most aspects of care as significantly more important than their partner although men and women evaluated the importance of the different care factors in a similar pattern. WHAT IS KNOWN ALREADY: A few validated tools measuring patient-centred quality of care during IVF have been developed. Few studies of gender differences concerning experiences of patient-centred quality of care have been reported in the literature to date. STUDY DESIGN, SIZE AND DURATION: A two-centre study was conducted between September 2011 and May 2012. Heterosexual couples (n = 497) undergoing IVF were invited to complete a questionnaire before receiving the result of the pregnancy test. PARTICIPANTS/MATERIALS, SETTING, METHODS: In all, 363 women and 292 men evaluated quality of care by answering the QPP-IVF questionnaire. The measurements consisted of two kinds of evaluations: the rating of the importance of various aspects of treatment (subjective importance) and the rating of perceived quality of care (perceived reality). Comparisons between men and women on importance ratings and perceived reality ratings were performed both on factor (subscale) and single item levels by intra-couple analyses and corrected for age. A stepwise multiple logistic regression analysis was performed in order to select baseline variables independently predicting evaluation at factor level. MAIN RESULTS AND THE ROLE OF CHANCE: The response rate was 67.5%, with 363 women (74.2%) and 292 men (60.6%) completing the study. Both the woman and man responded in 251 couples. Women rated the different care aspects as significantly more important than their partner in all factors except the factor, 'Responsibility/continuity'. Both genders gave the factors, 'Medical care' and 'Information after treatment', the highest scores. At item level women rated the majority of items as significantly more important than men. Perceived reality for the majority of factors and items was similarly rated by men and women in the couples. For women, receiving embryo transfer, short duration of infertility, IVF as a method and number of previous cycles were independently correlated to the highest score of importance of certain factors. LIMITATIONS, REASON FOR CAUTION: The lower response rate of men compared with women (60.6 versus 74.2%, respectively) might have influenced the results through selection bias. Only patients who had adequate fluency in the Swedish language participated. WIDER IMPLICATIONS OF THE FINDINGS: This study is an important contribution in comparing the needs of men and women undergoing IVF treatments. The QPP-IVF instrument is a suitable instrument for revealing important care aspects identified by both men and women and a useful tool for stimulating patient-centred quality improvements within and between clinics. STUDY FUNDING/COMPETING INTEREST: The study was supported by the LUA/ALF agreement at Sahlgrenska University Hospital, Gothenburg, Sweden, and by Hjalmar Svensson's Research Foundation. None of the authors declared any conflict of interests.

Quality of care in an IVF programme from a patient's perspective: development of a validated instrument.

STUDY QUESTION: Is it possible to develop a trustworthy instrument to evaluate the patient's perspective on fertility care and to document fully all methodological steps, including validation? SUMMARY ANSWER: A validated instrument has been developed for both women and men undergoing assisted reproduction to monitor the quality of care on a regular basis, similar to live birth rates and other effectiveness data. WHAT IS KNOWN ALREADY?: Within fertility care, several instruments have been developed, but many have significant methodological problems and few have been validated. Most instruments focus exclusively on women and no questionnaires have been directed at women and men separately. STUDY DESIGN, SIZE AND DURATION: The questionnaire specific to IVF treatments (QPP-IVF) is based on the theoretical foundation of the validated general instrument, quality of care from patients perspective (QPP), for both women and men. The QPP-IVF was developed and validated by quantitative methods. A two-centre study ran between September 2011 and May 2012. PARTICIPANTS/MATERIALS, SETTING, METHODS: In all, 655 women and men participated. The measurements consisted of two kinds of evaluations: the rating of perceived reality of care and the rating of the subjective importance of various aspects of treatment. The questionnaire consisted of 43 items for women and 42 items for men. An exploratory factor analysis was performed for women for all items of subjective importance. Eigenvalue, explained variance and factor loading are given for each factor. Internal consistency of subscales was assessed by Cronbach's alpha, item discriminant validity and percentage scaling success. For external validity, a correlation with fertility quality of life (FertiQoL) was performed and for reliability, a test-retest analysis was carried out. Sensitivity analyses were performed by known-group analyses. All significance tests were two sided and conducted at the 5% significance level. MAIN RESULTS AND THE ROLE OF CHANCE: The QPP-IVF instrument, divided into four dimensions, seemed a valid and reliable way of measuring the quality of care from a patient's perspective, for both women and men. The item-scaling test confirmed 10 underlying factors, with scaling success in all subscales and Cronbach's alpha >0.70 for women in almost all subscales. It was somewhat lower for men but still acceptable. The external validity was acceptable, with significant correlation between QPP-IVF and FertiQoL. The test-retest analysis confirmed that QPP-IVF was a stable instrument, with intra-class correlation coefficients from 0.74 to 0.89 for women. Sensitivity analyses indicated a sensitive instrument. LIMITATIONS, REASON FOR CAUTION: The response rate to the questionnaire was 67.5%. Although considered acceptable in questionnaire studies, this response level might introduce a certain risk of selection bias. The questionnaire was developed and validated only in Sweden. WIDER IMPLICATIONS OF THE FINDINGS: The QPP-IVF may be of use for purposes of quality improvement and national comparisons. Future studies should focus on establishing the QPP-IVF as a valuable instrument for measuring the quality of care outside Sweden. STUDY FUNDING/COMPETING INTEREST: The study was supported by the LUA/ALF agreement at Sahlgrenska University Hospital, Gothenburg, Sweden and by Hjalmar Svensson's Research Foundation. None of the authors declared any conflict of interests.

Nordic couples' decision-making processes during assisted reproduction treatments.

OBJECTIVE: To study couples' perceptions of their decision-making process during the first three years of infertility treatments. STUDY DESIGN: This study is a part of a larger project studying the decision-making processes of 22 infertile heterosexual couples, recruited from fertility clinics in all five Nordic countries, over a three year period. A descriptive qualitative method was used. MAIN OUTCOME MEASURES: Process of decision-making during assisted reproduction treatments. RESULTS: Seventeen couples had succeeded in becoming parents after approximately three years. Our study suggests that the decision-making process during fertility treatments has three phases: (i) recognizing the decisions to be made, with subcategories; the driving force, mutual project, (ii) gathering knowledge and experience about the options, with subcategories; trust, patient competence, personalized support, and (iii) adapting decisions to possible options, with subcategories; strategic planning, adaption. The core category was "maintaining control in a situation of uncertainty." CONCLUSIONS: Two parallel processes affect couples' decision-making process, one within themselves and their relationship, and the other in their contact with the fertility clinic. Couples struggle to make decisions, trusting clinic personnel for guidance, knowledge, and understanding. Nevertheless, couples expressed disappointment with the clinics' reactions to their requests for shared decision-making.

Cross-validation and predictive value of near-infrared spectroscopy algorithms for day-5 blastocyst transfer.

Near-infrared (NIR) spectroscopic metabolomic profiling of spent embryo-culture media has been used to calculate a viability score for individual embryos. These scores have been found to correlate to the reproductive potential of cleavage-stage embryos. In this study, 137 spent blastocyst media samples were collected after single-embryo transfer and analysed by NIR spectroscopy to generate an algorithm and calculate viability scores. To blindly validate the algorithm development process, another algorithm was trained on 47 preselected samples from clinic 1 and then used to predict the outcome of 42 samples from clinic 2. The overall pregnancy rate from the two clinical sites was 50.4%. A positive correlation (R(2)=0.82, P=0.03) was observed with the increasing viability score quintiles and their associated implantation rates. Cross-validation of an algorithm generated from NIR analysis of media samples at one clinical setting blindly was shown to predict implantation potential of blastocysts cultured at another clinic in a different culture media and culture volume. This study demonstrates that metabolomic profiling by NIR spectroscopic analysis of day-5 spent embryo-culture media can predict the implantation potential of blastocysts. Furthermore, this method may not be restricted to a specific set of culturing conditions. The successes of IVF treatment cycles are in part limited by the ability to select the best single embryo from a cohort of patient embryos for transfer back to the woman. Routine procedures of embryo selection are based on morphology, including cell number and size, and the timing of cell division. These methods are favoured because they are quick and easy to assess. Human embryos are grown in culture solutions, which are specific for their stage of development. Recent studies analysing the culture solution in which the embryo are grown, by near infrared (NIR) spectroscopic analysis, have been able to predict if an embryo will implant or not. As culture conditions often vary between IVF laboratories the questions remained if the NIR technique could be used to independently predict the implantation potential of an embryo cultured at one laboratory using an algorithm trained on embryos at a second clinic, a so-called cross-validation. The results of this study show that NIR spectroscopy can predict the ability of embryos to implant even when grown in different IVF laboratories and in two different culture solutions. This information supports the idea that NIR spectroscopy can be used globally not relying on specific culture conditions or media.

Access to artificial reproduction technology in the Nordic countries in 2004.

OBJECTIVE: To survey access to Artificial Reproduction Technology (ART) treatments in 2004 with regard to legislation, geographical location, financing and the kind of ART treatments provided in the Nordic countries. DESIGN: Retrospective descriptive survey of practice at ART clinics and legislation. SETTING: Denmark, Finland, Iceland, Norway and Sweden. SAMPLE: Sixty-six ART clinics registered with the Nordic Fertility Society in autumn 2005. METHODS: A questionnaire was sent to all ART clinics and a survey of legislation concerning ART treatments and public statistics was performed. The response rate was 79%. MAIN OUTCOME MEASURES: Access to ART treatments. RESULTS: The differences in legislation among the countries mainly concerns gamete donation. Couples living in larger cities or densely populated areas have best access to ART treatments. With regard to subsidizing of treatment costs, Finland and Denmark seem to be the best of the Nordic countries. CONCLUSIONS: The main differences among the countries concern the legislation, the cost of the treatments and how those are subsidized.

Improving the consistency of ovarian stimulation: follitropin alfa filled-by-mass.

In their quest for a child, infertile couples embark on a journey that is full of expectations and hopes. Over recent years, treatment procedures for assisted conception have become safer and more efficient. However, couples undergoing treatment can still experience some degree of emotional stress due to disappointment if pregnancy is not achieved, or if treatment cycles may have to be cancelled due to a low- or hyper-response. Strategies aimed at minimizing the variability of ovarian response or overall treatment outcome can be expected to significantly reduce this emotional stress. New developments have led to the production of follitropin alfa filled by mass. This is a highly consistent FSH preparation improving the consistency of ovarian response and reducing the risk of cycle cancellation. The impact of this new FSH preparation for assisted reproduction treatments is discussed in this review.

Granulocyte-macrophage colony-stimulating factor alleviates adverse consequences of embryo culture on fetal growth trajectory and placental morphogenesis.

Growth factors secreted by the female reproductive tract promote development of the preimplantation embryo and potentially act as epigenetic determinants of postimplantation developmental competence and pregnancy outcome. In a comprehensive embryo transfer study in mice, we examined the late gestational and postnatal effects of embryo exposure to the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF), identified as a key physiological regulator of cell number and viability in mouse and human blastocysts. Embryo development in culture in the absence of GM-CSF restricted fetal growth, accelerated postnatal growth, and increased adult body mass and adiposity in offspring compared with in vivo-grown embryos, especially in males. Addition of GM-CSF to embryo culture medium increased the proportion of transferred embryos that generated viable progeny and alleviated the effects of in vitro culture on fetal and postnatal growth trajectory but did not prevent programming of adult obesity. Placental morphogenesis was modified by embryo culture, which inhibited development of labyrinthine exchange tissue and adversely altered some structural correlates of placental transfer function. GM-CSF reversed the effect of culture on labyrinthine growth and increased the surface area of placental trophoblast available for nutrient exchange. These findings indicate that the detrimental influence of embryo culture on fetal viability and growth may be largely mediated through altered placental morphogenesis and can be alleviated by GM-CSF. This demonstrates that embryonic exposure to GM-CSF is essential for normal placental development and fetal growth.

Human blastocysts for the development of embryonic stem cells.

Establishment of human embryonic stem cells (hES) from surplus human IVF embryos has been successful when both fresh and frozen-thawed cleavage stage embryos have been cultured to the blastocyst stage. This study reports the characteristics of the starting material, the blastocysts, for hES cell lines that were first derived at the University of Gothenburg, Sahlgrenska University Hospital in 1999. Twenty-two hES cell lines were derived by Cellartis AB from 114 blastocysts, giving an overall success rate of 19.3%. The blastocysts from which the hES cell lines were established were of varying morphological quality, both fresh and frozen-thawed. Two techniques of hES establishment were applied, i.e. direct application of the blastocysts on feeder cells or the standard immunosurgery method. It was further found that the efficiency by which frozen-thawed embryos gave rise to new hES cell lines was 3.7 times better than with fresh surplus embryos. These findings suggest that frozen-thawed embryos are superior to fresh surplus human embryos in hES cell establishment, which also avoids specific ethical problems associated with embryo donation in a fresh IVF cycle.

Chromosomal abnormality rate in human pre-embryos derived from in vitro fertilization cycles cultured in the presence of Follicular-Fluid Meiosis Activating Sterol (FF-MAS).

BACKGROUND: The objective of the study was to investigate the effect of Follicular-Fluid Meiosis Activating Sterol (FF-MAS) when added to the culture media on the incidence of chromosomal abnormalities and pre-embryo development in human pre-embryos. METHODS: 243 women undergoing IVF/ICSI treatment donated 353 oocytes in a multicentre, prospective, randomized, double blind, four-arm, controlled trial performed at Danish and Swedish public and private IVF centers. Metaphase II oocytes were randomly assigned to: FF-MAS 5 microM, FF-MAS 20 microM, ethanol 0.2% (vehicle control) or water for injection (inert control). The exposure regimen of FF-MAS to the human oocytes was 4 h prior to fertilization by ICSI and 20 h exposure post ICSI. The primary endpoint was the incidence of numerical chromosomal abnormalities. Secondary endpoints were cleavage rate and pre-embryo quality. RESULT: On the pre-embryo level, no significant differences in chromosomal abnormality rate were observed among the four groups. However, the percentage of uniformly normal pre-embryos was significantly lower in the pooled FF-MAS group (5 microM: 12% and 20 microM: 17%) than in the pooled control group (inert control 32% and vehicle control 42%). A high level of mosaicism (41-60%) was found in all groups. At the blastomere level, the percentage of blastomeres categorized as normal was significantly lower in the FF-MAS 5 microM group (41%) and the FF-MAS 20 microM (29%) group versus the inert (52%) and the vehicle (61%) groups. Significantly reduced cleavage and good quality pre-embryo rates were found in both FF-MAS groups. CONCLUSION: FF-MAS increased the rate of aneuploidy and had detrimental effects on cleavage and pre-embryo development, when exposed both before and after fertilization.

A randomized, double-blind, controlled trial of the effect of adding follicular fluid meiosis activating sterol in an ethanol formulation to donated human cumulus-enclosed oocytes before fertilization.

OBJECTIVE: To evaluate the effect of follicular fluid meiosis activating sterol (FF-MAS) in a 0.2% ethanol formulation on chromosomal status and development of preembryos. DESIGN: Multicenter, prospective, randomized, double-blind, five parallel group, controlled trial. SETTING: Public and private IVF-clinics in Denmark and Sweden. PATIENT(S): Two hundred ten women undergoing IVF treatment donated 310 oocytes. INTERVENTIONS(S): FSH/hCG primed cumulus-enclosed oocytes randomized to 4 hours exposure of medium with 0.1, 1, or 10 microM FF-MAS dissolved in 0.2% ethanol, medium with ethanol 0.2%, or medium with water for injection (control) before insemination. MAIN OUTCOME MEASURE(S): Primary: incidence of human preembryos with chromosomal abnormalities. Secondary: fertilization rate, cleavage rate, and preembryo quality after 68 hours of culture. RESULT(S): At the preembryo level, no significant differences in chromosomal abnormality rate were found among any of the groups. At the blastomere level, a significant increased abnormality rate was observed in the ethanol group and the combined FF-MAS groups compared with the control group. No significant differences in fertilization rate, cleavage rate, or preembryo quality were observed among any of the groups and the control group except for a significant reduction in the number of embryos with >or=2 cells at 26 hours in the ethanol group. CONCLUSION(S): No negative effect of FF-MAS was observed. However, addition of ethanol 0.2% to standard IVF-medium with or without FF-MAS for culturing cumulus-enclosed oocytes for 4 hours before insemination increased the chromosomal abnormality rate at the blastomere level. Further studies of FF-MAS in a nonethanol formulation are under way.

Electro-acupuncture as a peroperative analgesic method and its effects on implantation rate and neuropeptide Y concentrations in follicular fluid.

BACKGROUND: In a previous study on the effect of electro-acupuncture (EA) in combination with a paracervical block (PCB) as an analgesic method during oocyte aspiration in IVF treatment, EA appeared to increase the pregnancy rate. This study was designed to test the hypothesis that EA as an analgesic during oocyte aspiration would result in: (i) a better IVF pregnancy rate than with alfentanil; (ii) peroperative analgesia that was as good as that produced by alfentanil; (iii) less postoperative abdominal pain, nausea and stress; and (iv) a reduction in the use of additional analgesics. Neuropeptide Y (NPY) concentrations in follicular fluid (FF) were analysed when possible. METHODS AND RESULTS: In this prospective, randomized, multicentre clinical trial, 286 women undergoing oocyte aspiration were randomly allocated to the EA group (EA plus a PCB) or to the alfentanil group (alfentanil plus a PCB). No significant differences were found between the EA and alfentanil groups in any of the IVF variables. NPY concentrations in FF were significantly higher in the EA group compared with the alfentanil group. No correlation between pregnancy rate and NPY concentrations was found in either analgesic group. Both EA plus a PCB and alfentanil plus a PCB induced adequate peroperative analgesia during oocyte aspiration evaluated using the visual analogue scale. After 2 h, the EA group reported significantly less abdominal pain, other pain, nausea and stress than the alfentanil group. In addition, the EA group received significantly lower amounts of additional alfentanil than the alfentanil group. CONCLUSION: EA does not improve pregnancy rate in the present clinical situation. The observation that NPY concentrations in FF were higher in the EA group may be important for human ovarian steroidogenesis. The analgesic effects produced by EA are as good as those produced by conventional analgesics, and the use of opiate analgesics with EA is lower than when conventional analgesics alone are used.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) acts independently of the beta common subunit of the GM-CSF receptor to prevent inner cell mass apoptosis in human embryos.

Granulocyte-macrophage colony-stimulating factor (GM-CSF) is expressed in the female reproductive tract during early pregnancy and can promote the growth and development of preimplantation embryos in several species. We have demonstrated with in vitro experiments that the incidence of blastulation in human embryos is increased approximately twofold when GM-CSF is present in the culture medium. In the present study, we investigated the mechanisms underlying the embryotrophic actions of GM-CSF. Using reverse transcription-polymerase chain reaction and immunocytochemistry, expression of mRNA and protein of the GM-CSF-receptor alpha subunit (GM-Ralpha) was detected in embryos from the first-cleavage through blastocyst stages of development, but the GM-CSF-receptor beta common subunit (betac) could not be detected at any stage. When neutralizing antibodies reactive with GM-Ralpha were added to embryo culture experiments, the development-promoting effect of GM-CSF was ablated. In contrast, GM-CSF activity in embryos was not inhibited either by antibodies to betac or by E21R, a synthetic GM-CSF analogue that acts to antagonize betac-mediated GM-CSF signaling. Unexpectedly, E21R was found to mimic native GM-CSF in promoting blastulation. When embryos were assessed for apoptosis and cell number by confocal microscopy after TUNEL and propidium iodine staining, it was found that blastocysts cultured in GM-CSF contained 50% fewer apoptotic nuclei and 30% more viable inner cell mass cells. Together, these data indicate that GM-CSF regulates cell viability in human embryos and that this potentially occurs through a novel receptor mechanism that is independent of betac.

Alternative treatments in reproductive medicine: much ado about nothing. Acupuncture-a method of treatment in reproductive medicine: lack of evidence of an effect does not equal evidence of the lack of an effect.

The increasing popularity of alternative treatments-methods of treatment that are not generally established in Western medicine-demands a serious debate about scientific documentation, efficacy and safety. It has been argued that there is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data, and we agree. Different methods of treatment, referred to as alternative treatments, are used by millions of patients every day which generates billions of dollars in health care expenditure each year. Therefore, it is important that physicians become more knowledgeable about different methods of treatment and increase their understanding of the possible benefits and limitations of each therapy. This article is intended to illustrate acupuncture in reproductive medicine today, as an example of a method of treatment that has become more established in Western medicine over the last decade. Discussed are the scientific documentation and aspects of acupuncture research, the physiological basis for the use of acupuncture, and evidence for the use of acupuncture in reproductive medicine. We are well aware that there are few well-designed papers on the effectiveness of different treatments in this field. However, we need to adhere to these principles, as we hope, do the readers of the present debate article.

Analysis of the cost effectiveness of recombinant versus urinary follicle-stimulating hormone in in vitro fertilization/intracytoplasmic sperm injection programs in the United States.

OBJECTIVE: To compare the cost effectiveness of recombinant human FSH (Gonal-F; Serono, Inc., Randolph, MA) and urinary FSH (Fertinex; Serono, Inc.) for ovarian stimulation during IVF with or without intracytoplasmic sperm injection for the treatment of infertility. DESIGN: Clinical decision analysis techniques (the Markov model) were used to model the direct medical costs per patient during assisted reproductive technology. MAIN OUTCOME MEASURE(S): Clinical and economic outcomes of two different ovarian stimulation protocols (recombinant human FSH or urinary FSH) during three treatment cycles were considered. RESULT(S): More ongoing pregnancies were achieved, with fewer stimulation cycles, after recombinant human FSH (Gonal-F) than after urinary FSH (Fertinex) (40,665 versus 37,890). In addition, recombinant human FSH was also found to be more cost effective per ongoing pregnancy. From a societal perspective, the mean cost per pregnancy was $40,688 for recombinant human FSH versus $47,096 for urinary FSH. From the insurers' perspective, the mean cost/pregnancy for recombinant human FSH was $28,481 versus $32,967 for urinary FSH. CONCLUSION(S): Recombinant human FSH (Gonal-F) is not only more efficient clinically than urinary FSH (Fertinex), but also more cost effective. This analysis illustrates the point that the economic effectiveness of a drug depends less on its acquisition costs and rather more on the clinical outcomes associated with its use.

Is your IVF programme good?

Few standards exist today to assess the quality of an IVF centre. Although much focus is placed upon pregnancy rates, emphasis on this outcome alone is inadequate. The purpose of this report is to examine those factors that should be considered in assessing the overall quality of an IVF centre. Current methods to assess quality are reviewed. Many governing bodies throughout the world currently focus solely on pregnancy rates, which can be misguided if factors such as multiple pregnancies, ovarian hyperstimulation, patient satisfaction, and the proper evaluation of laboratory and clinical protocols are not taken into account. Measurements of quality and methods to improve it are critical in all business models, including IVF. We propose an international standard such as the ISO 9001 for IVF centres to properly evaluate and improve the delivery of their care.