Potential Costs and Benefits of Incorporating PGT-A Across Age Groups: A Canadian Clinic Perspective.

OBJECTIVE: To assess the potential costs and benefits of preimplantation genetic testing for aneuploidy (PGT-A) across age groups, considering financial costs, total euploidy rates and the potential for morphology grading to predict a euploid embryo. METHODS: This study is a blinded retrospective chart review of patients who incorporated PGT-A as part of their in vitro fertilization (IVF) treatment cycle at a university-affiliated fertility clinic. Patients between 25-44 years of age undergoing IVF with intracytoplasmic sperm injection and PGT-A with autologous oocytes (n = 220) were included in this study. Number of blastocysts achieved, euploidy rates and PGT-A costs were compared between 3 age groups: <35 years, 35-37, and ≥38. Additionally, agreement on the top-quality embryo based on morphology assessment alone versus PGT-A selection was analyzed and further compared based on the number of blastocysts achieved. RESULTS: A significant negative correlation between patient age and number of embryos produced, PGT-A costs, and euploidy rates (P < 0.001) was observed. Additionally, morphology alone ratings were able to predict the top-quality euploid embryo 78% of the time in the <35 age group, but only 32% of the time in the ≥38 age group (P < 0.05), with a trend toward even lower agreement when 3 or fewer blastocysts were produced. CONCLUSION: Based on our cost analysis, it may be advantageous to incorporate PGT-A when maternal age is ≥38, given the lower financial costs associated with each cycle and the low likelihood of transferring a euploid embryo on the first attempt for this age group. Nevertheless, we acknowledge that PGT-A remains a complex decision influenced by a multitude of factors.

Preimplantation genetic testing for BRCA gene mutation carriers: a cost effectiveness analysis.

BACKGROUND: Gynecologic oncologists should be aware of the option of conception through IVF/PGT-M for families with high BRCA related morbidity or mortality. Our objective was to investigate the cost-effectiveness of preimplantation genetic testing for selection and transfer of BRCA negative embryo in BRCA mutation carriers compared to natural conception. METHODS: Cost-effectiveness of two strategies, conception through IVF/PGT-M and BRCA negative embryo transfer versus natural conception with a 50% chance of BRCA positive newborn for BRCA mutation carriers was compared using a Markovian process decision analysis model. Costs of the two strategies were compared using quality adjusted life years (QALYs'). All costs were discounted at 3%. Incremental cost effectiveness ratio (ICER) compared to willingness to pay threshold was used for cost-effectiveness analysis. RESULTS: IVF/ PGT-M is cost-effective with an ICER of 150,219 new Israeli Shekels, per QALY gained (equivalent to 44,480 USD), at a 3% discount rate. CONCLUSIONS: IVF/ PGT-M and BRCA negative embryo transfer compared to natural conception among BRCA positive parents is cost effective and may be offered for selected couples with high BRCA mutation related morbidity or mortality. Our results could impact decisions regarding conception among BRCA positive couples and health care providers.

In-vitro maturation versus IVF: a cost-effectiveness analysis.

RESEARCH QUESTION: How do costs and effects of in-vitro maturation (IVM) compare to IVF in women with a high antral follicle count (AFC)? DESIGN: This cost-effectiveness analysis (CEA) was based on data of a previous retrospective cohort study at IVFMD, My Duc Hospital, Ho Chi Minh City, Vietnam. Between July 2015 and December 2017, 608 women underwent IVM and 311 women IVF. The effectiveness measure for the CEA was cumulative live birth rate (LBR) after one completed cycle including subsequent cryo-cycles within 12 months of inclusion. Data were collected on resource use related to treatment, medication and pregnancy from the case report forms. The mean costs and effects, average cost differences and incremental cost-effectiveness ratios (ICER) were calculated using non-parametric bootstrap resampling to assess the effect of uncertainty in the estimates. RESULTS: Cumulative LBR after one completed cycle were 239/608 (39.3%) in the IVM group versus 155/311 (49.8%) in the IVF group (adjusted odds ratio 0.52, 95% confidence interval [CI] 0.30-0.89). Ovarian hyperstimulation syndrome (OHSS) did not occur in the IVM group versus 11/311 (3.5%) in the IVF group. The mean costs per couple were €4300 (95% CI €1371-18,798) for IVM and €6493 (95% CI €2204-20,136) for IVF. The ICER per additional live birth with IVF was €20,144 (95% CI €9116-50,418). Results were robust over a wide range of assumptions. CONCLUSIONS: IVM is less expensive than IVF in women with a high AFC undergoing treatment with assisted reproductive technology, while leading to a slightly lower effectiveness in terms of cumulative LBR.

Measuring success in IVF is a complex multidisciplinary task: time for a consensus?

The goal of an IVF cycle is the birth of at least one baby per intention to treat. However, IVF cannot confer competence on an embryo, but only can provide each couple with a safe treatment to meet a predetermined chance of success. This commentary highlights how clinical, financial and patient-centred perspectives should be included in the definition of success in IVF. The primary outcome, which is the cumulative live birth delivery rate per intention to treat, must always be complemented by analyses of risks, costs and time invested, as well as by measures of patient satisfaction. Finally, it is essential, whenever clinical conditions exist, to limit treatment discontinuation after failed attempts. Constant monitoring of the data is pivotal and must be adjusted for patient characteristics and compared with national and international registers. The authors aimed to review all these aspects and highlight the points that are still open for discussion. Is it time for a consensus?

Prevalence and characteristics of patients declined from pursuing in vitro fertilization with autologous oocytes.

PURPOSE: To determine the frequency of and factors associated with a patient being declined from pursuing a cycle of in vitro fertilization with autologous oocytes (IVF-AO). METHODS: A cross-sectional study using a nationwide cohort of female respondents aged 35 or over, who visited a US fertility clinic from 1/2015 to 3/2020, responded to the online FertilityIQ questionnaire ( http://www.fertilityiq.com ). All respondents were asked if they were previously declined from pursuing a cycle of IVF-AO. Examined demographic and clinical predictors included age, race/ethnicity, education, income, clinic type, care received in a mandated state, insurance coverage for fertility treatment, and self-reported infertility diagnosis. Logistic regression was used to calculate the adjusted odds ratios for factors associated with being declined from pursuing IVF-AO. RESULTS: Of 8660 women who met inclusion criteria, 418 (4.8%) reported previously being declined a cycle of IVF-AO. In the multivariate analysis, predictors of being declined from pursuing IVF-AO included increasing age, income of less than $50,000, and diagnoses of poor oocyte quality and diminished ovarian reserve. Predictors of being less likely to report decline included some college or college degree and diagnoses of male factor, unexplained or tubal infertility. Notably, diagnosis of PCOS or residence in a state with mandated fertility coverage was not predictive of patients being declined from pursuing IVF-AO. CONCLUSION: Nearly 5% of patients who pursued IVF reported being declined from pursuing IVF-AO. Further studies are needed to confirm our findings and explore whether patients being declined treatment meet the criteria for futile or very poor prognosis.

The prevalence, promotion and pricing of three IVF add-ons on fertility clinic websites.

RESEARCH QUESTION: How are IVF clinic websites advertising three common IVF add-ons: assisted hatching, time-lapse embryo imaging and preimplantation genetic testing for aneuploidies (PGT-A)? DESIGN: The Human Fertilisation and Embryology Authority 'Choose a fertility clinic' website service was used to identify IVF clinics and their websites. Assisted hatching, time-lapse embryo imaging and PGT-A were examined to determine which websites advertised them, what price they charged and what claims they made in relation to the add-ons. RESULTS: Eighty-seven eligible clinics were identified, with 72 unique websites; 37 (43%) clinics were part of one of nine groups of IVF clinics, of sizes ranging from two to eight clinics in the UK. Time-lapse imaging (TLI) was the most frequently advertised of the three add-ons (67% of clinics), followed by PGT-A (47%) and assisted hatching (28%). Very few websites stated that the effectiveness of the add-on was in doubt or unclear (four, two and one websites for TLI, PGT-A and assisted hatching, respectively), and none raised the possibility that an add-on might have negative effects. Claims of efficacy were often based on upstream outcomes (e.g. implantation, pregnancy). Some claims that PGT-A and TLI improved live birth rates were found. There was substantial variation in pricing. CONCLUSIONS: IVF clinic websites provide valuable information for patients seeking fertility treatment so it is key that the information is accurate and complete. There is a need for transparent information on interventions, including uncertainties and risks, to be made available by IVF clinics to support well-informed treatment decisions. The selected add-ons are widely advertised, and there is wide variation in pricing.

Gonadotrophins or clomiphene citrate in couples with unexplained infertility undergoing intrauterine insemination: a cost-effectiveness analysis.

RESEARCH QUESTION: What is the cost-effectiveness of gonadotrophins compared with clomiphene citrate in couples with unexplained subfertility undergoing intrauterine insemination (IUI) with ovarian stimulation under strict cancellation criteria? DESIGN: A cost-effectiveness analysis alongside a randomized controlled trial (RCT). Between July 2013 and March 2016, 738 couples were randomized to gonadotrophins (369) or clomiphene citrate (369) in a multicentre RCT in the Netherlands. The direct medical costs of both strategies were compared. Direct medical costs included costs of medication, cycle monitoring, insemination and, if applicable, pregnancy monitoring. Non-parametric bootstrap resampling was used to investigate the effect of uncertainty in estimates. The cost-effectiveness analysis was performed according to intention-to-treat. The incremental cost-effectiveness ratio (ICER) between gonadotrophins and clomiphene citrate for ongoing pregnancy and live birth was assessed. RESULTS: The mean costs per couple were €1534 for gonadotrophins and €1067 for clomiphene citrate (mean difference of €468; 95% confidence interval [CI] €464-472). As ongoing pregnancy rates were 31% in women allocated to gonadotrophins and 26% in women allocated to clomiphene citrate (relative risk 1.16, 95% CI 0.93-1.47), the ICER was €21,804 (95% CI €11,628-31,980) per additional ongoing pregnancy with gonadotrophins and €17,044 (95% CI €8998-25,090) per additional live birth with gonadotrophins. CONCLUSIONS: Gonadotrophins are more expensive compared with clomiphene citrate in couples with unexplained subfertility undergoing IUI with adherence to strict cancellation criteria, without being significantly more effective.

Replacing HMG/FSH by low-dose HCG to complete corifollitropin alfa stimulation reduces cost per clinical pregnancy: a randomized pragmatic trial.

RESEARCH QUESTION: The cost of IVF treatment remains high, among other factors because of the medication needed for ovarian stimulation. This study investigated the effect of using low-dose human chorionic gonadotrophin (HCG) for the second phase of follicular maturation after corifollitropin alfa induction, to replace the more expensive, either recombinant or human menopausal gonadotrophin (HMG), on the cost of ovarian stimulation. DESIGN: One hundred and five patients were randomly divided into two groups: patients in the HCG group (n = 50) received low-dose HCG from Day 7 until the diameter of at least three follicles reached 17 mm or more, while patients in the FSH group (n = 55) received conventional ovarian stimulation with highly purified HMG injections. RESULTS: The clinical pregnancy rate in the HCG group was 38% higher than in the FSH group (number needed to treat, NNT = 13). The cost per pregnancy needed for ovarian stimulation was reduced from €4902 in the FSH group to €2684 in the HCG group. Hence, the cost of ovarian stimulation medication to obtain 10 pregnancies using the conventional FSH protocol is sufficient to attain 18 pregnancies when applying the low-dose HCG protocol. CONCLUSION: This study provides evidence that using HCG instead of HMG/FSH for ovarian stimulation results in a significant reduction in the cost of IVF with, at least, an equivalent pregnancy rate.

The social paradoxes of commercial surrogacy in developing countries: India before the new law of 2018.

BACKGROUND: Commercial surrogacy is a highly controversial issue that leads to heated debates in the feminist literature, especially when surrogacy takes place in developing countries and when it is performed by local women for wealthy international individuals. The objective of this article is to confront common assumptions with the narratives and experiences described by Indian surrogates themselves. METHODS: This qualitative study included 33 surrogates interviewed in India (Mumbai, Chennai and New Delhi) who were at different stages of the surrogacy process. They were recruited through five clinics and agencies. This 2-year field study was conducted before the 2018 surrogacy law. RESULTS: Surrogates met the criteria fixed by the national guidelines in terms of age and marital and family situation. The commitment to surrogacy had generally been decided with the husband. Its aim was above all to improve the socioeconomic condition of the family. Women described surrogacy as offering better conditions than their previous paid activity. They had clear views on the child and their work. However, they declared that they faced difficulties and social condemnation as surrogacy is associated with extra-marital relationships. They also described a medical process in which they had no autonomy although they did not express complaints. Overall, surrogates did not portray themselves as vulnerable women and victims, but rather as mothers and spouses taking control of their destiny. CONCLUSIONS: The reality of surrogacy in India embraces antagonistic features that we analyze in this paper as "paradoxes". First, while women have become surrogates in response to gender constraints as mothers and wives, yet in so doing they have gone against gender norms. Secondly, while surrogacy was socially perceived as dirty work undertaken in order to survive, surrogates used surrogacy as a means to upward mobility for themselves and their children. Finally, while surrogacy was organized to counteract accusations of exploitation, surrogates were under constant domination by the medical system and had no decision-making power in the surrogacy process. This echoes their daily life as women. Although the Indian legal framework has changed, surrogacy still challenges gender norms, particularly in other developing countries where the practice is emerging.

The Affordability and Accessibility of Ontario's Publicly Funded IVF Program: A Survey of Patients.

OBJECTIVE: On December 21, 2015, the Province of Ontario created the Ontario Fertility Program to fund one cycle of in vitro fertilization (IVF) to improve IVF affordability and access for Ontarians below age 43. The objective of this study was to determine whether the Program was meeting this goal, based on the experiences of participating patients. METHODS: Participation in an electronic survey was invited through posters and brochures placed within the waiting rooms of all 25 IVF clinics providing funded IVF in Ontario and by a survey link placed on websites focused on fertility issues. RESULTS: The survey was carried out at the end of the second year of the Program (September to December 2017), with 514 participants completing >75% of it. Program strengths were noted as follows: decreases in financial inequities of family building for the infertile; lowering of the opportunity cost of accessing IVF; and destigmatizing and raising public awareness of infertility as a legitimate medical condition. Weaknesses were as follows: lack transparency and consistency in clinics' patient prioritization schemes; clinic concentration in cities leading to geographic inequities in access; and high ancillary costs being financially burdensome. The following opportunities were suggested: funding of more than one IVF cycle and its supporting medications; standardization of prioritization schemes; and tying Program access to means testing. CONCLUSION: Patients strongly support the Program and noted improved IVF affordability, but the Program's reliance on existing private clinics for treatment provision has meant unresolved geographic inequities and inconsistent prioritization schemes. Because this is the first Program study of patients' experience, the results will help policymakers determine areas to re-evaluate for continued or increased funding and opportunities to collaborate with health care providers and clinic owners to improve provision and access.

Microbial contamination in assisted reproductive technology: source, prevalence, and cost.

Even the strictest laboratories and clinics are prone to the occurrence of microbial contamination. In the case of in vitro fertilization (IVF) research and practice facilities, the number of possible sources is particularly vast. In addition to ambient air, personnel, and non-sterilized materials, follicular fluid and semen from patients are a very common gateway for a diverse range of bacteria and fungi into embryo cultures. Even so, reports of contamination cases are rare, what leads many clinics to see the issue as a negligible risk. Microbiological contamination may result in the demise of the patient's embryos, leading to additional costs to both the patient and the clinics. Regardless of financial loss, emotional costs, and stress levels during IVF are highly distressing. Other worrisome consequences include DNA fragmentation, poor-quality embryos, early pregnancy loss or preterm birth, and possible long-term damages that need further investigation. In this review, we aimed to shed a light on the issue that we consider largely underestimated and to be the underlying cause of poor IVF outcomes in many cases. We also discuss the composition of the microbiome and how its interaction with the reproductive tract of IVF-seeking patients might influence their outcomes. In conclusion, we urge clinics to more rigorously identify, register, and report contamination occurrences, and highlight the role of the study of the microbiome to improve overall results and safety of assisted reproduction.

Is it ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it?

In vitro fertilisation (IVF) 'add-ons' are therapeutic or diagnostic tools developed in an endeavour to improve the success rate of infertility treatment. However, there is no conclusive evidence that these interventions are a beneficial or effective adjunct of assisted reproductive technologies. Additionally, IVF add-ons are often implemented in clinical practice before their safety can be thoroughly ascertained. Yet, patients continue to request and pay large sums for such additional IVF tools. Hence, this essay set out to examine if it is ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it. In order to determine what is ethical-namely, morally good and righteous, the question was considered in relation to three key values of medical ethics-autonomy, beneficence and non-maleficence. It was determined that providing IVF add-ons might be morally acceptable in specific circumstances, if true informed consent can be given, there is a potential of cost-effective physiological or psychological benefit and the risk of harm is minimal, particularly with regard to the unborn child.

Business models and provider satisfaction in in vitro fertilization centers in the USA.

PURPOSE: The number of in vitro fertilization (IVF) cycles is increasing and the majority of patients undergoing IVF pay out of pocket. Reproductive endocrinology and infertility practitioners employ different business models to help create financial pathways for patients needing IVF but details regarding the different types of business models being used and physician satisfaction with those models have not been described previously. METHODS: A cross-sectional survey was sent to members of the Society of Reproductive Endocrinology and Infertility. The survey included 30 questions designed to assess demographics, practice patterns, and business models utilized. RESULTS: A total of 222/736 (30%) physicians responded to the survey. The majority of physicians offer a-la-carte (67%), bundled services (69%), grants (57%), and cost/risk-sharing (50%). The majority answered that the single ideal business model is bundled services (53%). There was no significant association between financial package offered and region of practice or state-mandated insurance. The largest barrier to care reported was cost with or without state-mandated coverage (94% and 99%, respectively). The majority of practices are satisfied with their business model (75%). Higher physician satisfaction was associated with private practice [69% vs 27%; OR (95%CI) = 3.8 (1.7, 8.6)], male gender [59% vs 30%; OR = 2.4 (1.1, 5.4)], and offering bundled services [83% vs 59%; OR = 2.8 (1.2, 6.7)]. CONCLUSIONS: Physicians utilize a variety of business models and most are satisfied with their current model. Cost is the major barrier to care in states with and without mandated coverage.

The Impact of the Economic Recession in Greece on Assisted Reproduction Demand: A Retrospective Longitudinal Study.

BACKGROUND AND OBJECTIVES: Since 2009, the decline of the Greek economy has been in the spotlight of the world's financial agenda. This study assesses the economic crisis' impact on assisted reproduction demand dynamics. MATERIALS AND METHODS: Patient records were recruited between 2005-2017. In 2013 the clinic proceeded with a cost reduction. The studied time-frames were defined accordingly: Period A: Prior to economic crisis, Period B: During the economic crisis-prior to cost reduction, and Period C: During the economic crisis-following cost reduction. Analysis focused on parameters reflecting on patient characteristics, decision to inquire on IVF treatment, embarking on it, and proceeding with multiple cycles. RESULTS: The mean annual number of first visit patients was significantly decreased during Period B (1467.00 ± 119.21) in comparison to period A (1644.40 ± 42.57) and C (1637.8 ± 77.23). Furthermore, Period C in comparison to B and A, refers to women of more advanced age (37.27 ± 5.62 vs 36.04 ± 5.76 vs 35.53 ± 5.28), reporting a longer infertility period (8.49 ± 6.25 vs 7.01 ± 5.66 vs 6.46 ± 5.20), being inclined to abandon IVF treatment sooner (2.78 ± 2.51 vs 2.60 ± 1.92 vs 4.91 ± 2.28). CONCLUSIONS: A decline regarding assisted reproduction techniques (ART) demand was noted as anticipated. Redefining the cost of infertility treatments may contribute towards overcoming the troubling phenomenon of postponing pregnancy due to financial concerns.

[Economic studies of in vitro fertilization and embryo transfer].

In vitro fertilization and embryo transplantation (IVF-ET) technology is one of the main treatments for infertility. But IVF-ET is expensive and has not be covered by health insurance in most developing countries. Therefore, how to obtain the maximum success rate with the minimum cost is a common concern of clinicians and patients. At present, the economic studies on IVF-ET mainly focus on different ovulation stimulating drugs, different ovulation stimulating protocols, different transplantation methods and the number of transplants. But the process of IVF-ET is complex, the relevant methods of economic study are diverse, and there are no unified standard for outcome indicators, so there is no unified conclusion for more economical and effective protocol by now. Therefore, to analyze the economic studies of IVF-ET, and to explore appropriate evaluation methods and cost-effective protocols will be helpful for reasonable allocation of medical resources and guidance of clinical selection. It would provide policy reference to include the costs of IVF-ET treatment in health insurance in the future.

A cost-effectiveness analysis of freeze-only or fresh embryo transfer in IVF of non-PCOS women.

STUDY QUESTION: Is a freeze-only strategy more cost-effective from a patient perspective than fresh embryo transfer (ET) after one completed In Vitro Fertilization/ Intracytoplasmic Sperm Injection (IVF/ICSI) cycle in women without polycystic ovary syndrome (PCOS)? SUMMARY ANSWER: There is a low probability of the freeze-only strategy being cost-effective over the fresh ET strategy for non-PCOS women undergoing IVF/ICSI. WHAT IS KNOWN ALREADY: Conventionally, IVF embryos are transferred in the same cycle in which oocytes are collected, while any remaining embryos are frozen and stored. We recently evaluated the effectiveness of a freeze-only strategy compared with a fresh ET strategy in a randomized controlled trial (RCT). There was no difference in live birth rate between the two strategies. STUDY DESIGN, SIZE, DURATION: A cost-effectiveness analysis (CEA) was performed alongside the RCT to compare a freeze-only strategy with a fresh ET strategy in non-PCOS women undergoing IVF/ICSI. The effectiveness measure for the CEA was the live birth rate. Data on the IVF procedure, pregnancy outcomes and complications were collected from chart review; additional information was obtained using patient questionnaires, by telephone. PARTICIPANTS/MATERIALS, SETTING, METHODS: For all patients, we measured the direct medical costs relating to treatment (cryopreservation, pregnancy follow-up, delivery), direct non-medical costs (travel, accommodation) and indirect costs (income lost). The direct cost data were calculated from resources obtained from patient records and prices were applied based on a micro-costing approach. Indirect costs were calculated based on responses to the questionnaire. Patients were followed until all embryos obtained from a single controlled ovarian hyperstimulation cycle were used or a live birth was achieved. The incremental cost-effectiveness ratio (ICER) was based on the incremental cost per couple and the incremental live birth rate of the freeze-only strategy compared with the fresh ET strategy. Probabilistic sensitivity analysis (PSA) and a cost-effectiveness acceptability curve (CEAC) were also performed. MAIN RESULTS AND THE ROLE OF CHANCE: Between June 2015 and April 2016, 782 couples were randomized to a freeze-only (n = 391) or a fresh ET strategy (n = 391). Baseline characteristics including mean age, Body Mass Index (BMI), anti-Mullerian hormone, total dose of Follicle Stimulating Hormone (FSH), number of oocytes obtained, good quality Day 3 embryos, fertility outcomes and treatment complications were comparable between the two groups. The live birth rate (48.6% vs. 47.3%, respectively; risk ratio, 1.03; 95% Confidence Interval [CI], 0.89, 1.19; P = 0.78) and the average cost per couple (3906 vs. 3512 EUR, respectively; absolute difference 393.6, 95% CI, -76.2, 863.5; P = 0.1) were similar in the freeze-only group versus fresh ET. Corresponding costs per live birth were 8037 EUR versus 7425 EUR in the freeze-only versus fresh ET group, respectively. The incremental cost for the freeze-only strategy compared with fresh ET was 30 997 EUR per 1% additional live birth rate. The direct non-medical costs and indirect costs of infertility treatment strategies represented ~45-52% of the total cost. PSA shows that the 95% CI of ICERs was -263 901 to 286 681 EUR. Out of 1000 simulations, 44% resulted in negative ICERs, including 13.0% of simulations in which the freeze-only strategy was dominant (more effective and less costly than fresh ET), and 31% of simulations in which the fresh embryo strategy was dominant. In the other 560 simulations with positive ICERs, the 95% CI of ICERs ranged from 2155 to 471 578 EUR. The CEAC shows that at a willingness to pay threshold of 300 000 EUR, the probability of the freeze-only strategy being cost-effective over the fresh ET strategy would be 58%. LIMITATIONS, REASONS FOR CAUTION: Data were collected from a single private IVF center study in Vietnam where there is no public or insurance funding of IVF. Unit costs obtained might not be representative of other settings. Data obtained from secondary sources (medical records, financial and activity reports) could lack authenticity, and recall bias may have influenced questionnaire responses on which direct costs were based. WIDER IMPLICATIONS OF THE FINDINGS: In non-PCOS women undergoing IVF/ICSI, the results suggested that the freeze-only strategy was not cost-effective compared with fresh ET from a patient perspective. These findings indicate that other factors could be more important in deciding whether to use a freeze-only versus fresh ET strategy in this patient group. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by My Duc Hospital; no external funding was received. Ben Willem J. Mol is supported by an NHMRC Practioner Fellowship (GNT 1082548) and reports consultancy for Merck, ObsEva and Guerbet. Robert J. Norman has shares in an IVF company and has received support from Merck and Ferring. All other authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: Not applicable.

Probabilistic cost-effectiveness analysis of controlled ovarian stimulation with recombinant FSH plus recombinant LH vs. human menopausal gonadotropin for women undergoing IVF.

BACKGROUND: The association of recombinant FSH plus recombinant LH in 2:1 ratio may be used not only to induce ovulation in anovulatory women with hypogonadotropic hypogonadism but also to achieve multiple follicular developments in human IVF. The aim of this analysis was to estimate the cost-effectiveness of Controlled Ovarian Stimulation (COS) with recombinant FSH (rFSH) plus recombinant LH (rLH) in comparison with highly purified human menopausal gonadotropin (HP-hMG) in the woman undergoing in vitro fertilization (IVF) in Italy. METHODS: A probabilistic decision tree was developed to simulate patients undergoing IVF, either using r-FSH + r-LH or HP-hMG to obtain COS. The model considers the National Health System (NHS) perspective and a time horizon equal to two years. Simulations were reported considering the number of retrieved oocytes (5-9, 10-15 and > 15) and transition probabilities were estimated through specific analyses carried out on the population of 848 women enrolled in the real-life. RESULTS: The model estimated that patients undertaking therapeutic protocol with r-FSH + r-LH increase the general success rate (+ 6.6% for pregnancy). The incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) of r-FSH + r-LH was below the willingness to pay set at €20,000 for all the considered scenarios. CONCLUSIONS: The cost-utility analysis demonstrated that the r-FSH + r-LH is a cost-effective option for the Italian National Health System (NHS).

Cost-effectiveness modelling of IVF in couples with unexplained infertility.

RESEARCH QUESTION: Does delaying IVF for 6 months in couples with unexplained infertility, compared with immediate IVF treatment, decrease the cost of IVF without compromising success rates? DESIGN: Decision modelling was used to evaluate the cost and outcomes of immediate IVF versus delayed IVF for a cohort of women aged <40 years suffering unexplained infertility. Australian data and costs were used in the analysis. For different age groups, three scenarios were tested where 10%, 50% and 90% of couples with unexplained infertility delayed IVF for 6 months if they had a good prognosis for natural conception. The study included a total of 8781 couples aged <40 years, diagnosed with unexplained infertility and who had IVF in 2013. RESULTS: The studied couples underwent 27,648 fresh and frozen embryo transfers, for an estimated total cost of $141 million. Potential out-of-pocket cost savings if 90% of couples delayed IVF ranged from $4.7 to $12.2 million, with Medicare cost savings of up to $15.1 million. The impact on the total pregnancy and live birth rates after 18 months was minimal. CONCLUSIONS: In couples with unexplained infertility and a good prognosis for natural conception, delaying IVF for 6 months could substantially decrease out-of-pocket costs without compromising pregnancy and live birth rates over an 18-month period.

Impediments to communication and relationships between infertility care providers and patients.

BACKGROUND: Infertility patients generally see provider-patient communication and relationships as important, but as often insufficient, raising critical questions regarding why these gaps persist, and how they might best be addressed. METHODS: Semi-structured interviews of approximately one hour each were conducted with 37 ART providers and patients (17 physicians, 10 other health providers, and 10 patients) and were thematically analyzed. RESULTS: Patients see clinicians' interactions as ranging widely from good to bad, related to several specific barriers and factors. Patients and providers may differ in their physical and emotional experiences, expectations concerning treatment outcomes and uncertainties, and time frames and finances, generating dynamic processes and tensions. Characteristics of particular providers, clinics and patients can also vary. Infertility patients tend to find only one outcome acceptable - a "take home baby" - rather than partial success, as is the case with many other diseases. Yet most IVF cycles fail. Many patients must pay considerable out-of-pocket expenses for infertility treatment, exacerbating disappointments and frustrations. Providers often work in competitive, entrepreneurial markets, and "hype" their potential success. After treatment failures, providers may feel guilty and withdraw from patients. Yet these behaviors can antagonize patients more than physicians realize, aggravating patient stresses. Several providers described how they understood patients' needs and perceptions more fully only after becoming infertility patients themselves. Interactions with not only physicians, but other providers (e.g., nurses and staff) can play key roles. Patients may be willing to understand these impediments, but providers often communicate these obstacles and reasons poorly or not at all, furthering tensions. CONCLUSIONS: These data, the first to examine several critical aspects of challenges that infertility providers and patients face in communication and relationships, suggest that several key dynamic processes and factors may be involved, and need to be addressed. While prior research has shown that infertility patients value, but often feel disappointed in relationships with clinicians, the present data highlight several specific impediments, and thus have critical implications for future practice, research, guidelines and education.

Health Care Access, Costs, and Treatment Dynamics: Evidence from In Vitro Fertilization.

We study public policies designed to improve access and reduce costs for in vitro fertilization (IVF). High out-of-pocket prices can deter potential patients from IVF, while active patients have an incentive to risk costly high-order pregnancies to improve their odds of treatment success. We analyze IVF's rich choice structure by estimating a dynamic model of patients' choices within and across treatments. Policy simulations show that insurance mandates for treatment or hard limits on treatment aggressiveness can improve access or costs, but not both. Insurance plus price-based incentives against risky treatment, however, can together improve patient welfare and reduce medical costs.