Impact of insurance coverage on access to assisted reproductive technology: A nationwide survey in Japan (the IZANAMI project)

Abstract

Aim

Assisted reproductive technology (ART) is a well‐established infertility treatment. However, financial and geographical barriers can hinder patient access. The Japanese government implemented insurance coverage in April 2022 for specific ART treatments. This study assessed the effects of insurance coverage on ART utilization and accessibility.

Methods

An online survey was administered to 427 ART facilities that participated in a pre‐policy assessment from December 1, 2023, to January 30, 2024.

Results

A total of 283 facilities responded (response rate: 66.3%). The number of ART patients increased by 4.0% (217 699–226 401) following the implementation of insurance coverage. The number of insured patients aged 25–43 years increased by 6.6%, with a notable increase of 22.9% (range: 44 144–54 253) in the 25‐ to 34‐year age group. However, the number of uninsured patients aged ≥44 decreased by 16.3%; 172 facilities experienced an increased number of patients, whereas 111 facilities experienced no increase or decline. Patient growth rates were significantly higher in rural areas than in metropolitan regions (mean difference: 0.07; 95% confidence interval: 0.0–0.1; p = 0.03). Although there was a significant negative association between the proportion of out‐of‐pocket treatment and the rate of patient increase (p = 0.02), no such association was observed in rural areas (p = 0.68).

Conclusions

Insurance coverage improved patient access to ART services, especially for those in their 20s and early 30s. However, the number of patients in the uninsured group decreased significantly. Accessibility in rural areas also notably improved. These findings highlight the importance of economic support for enhancing ART accessibility.

INTRODUCTION

Japan is undergoing a significant demographic shift characterized by a declining birth rate and an aging population. In 2023, the number of live births declined to 727 277, and the total fertility rate reached a historic low of 1.20. Against this backdrop, assisted reproductive technology (ART) has become essential for the treatment of infertility. In 2022, 543 630 ART cycles were performed nationwide, resulting in 77 206 neonates born through ART, accounting for approximately 10% of all live births that year. ¹

Despite the growing importance of ART, it remains a financial burden for many patients. Economic constraints, advanced maternal age, geographic distance, history of unsuccessful childbirth, and poor ovarian response (i.e., low oocyte yield or failure to obtain viable embryos for cryopreservation) have been identified as significant predictors of ART discontinuation. ² In the United States, where ART services are not universally covered by insurance, the estimated cost of a single in vitro fertilization (IVF) cycle is approximately $12 500. ³ Similarly, in Japan, ART has historically been provided as an out‐of‐pocket service, placing a substantial financial burden on patients. The cost of a single IVF cycle, including pretreatment evaluations, ovulation stimulation, oocyte retrieval, and embryo transfer (ET), ranges from ¥400 000 ($2697) to ¥500 000 ($3371), with a mean of ¥501 284 ($3380) and a median of ¥500 000 ($3371). ⁴ Given that 83.9% of the patients (385/439) underwent up to five IVF cycles, the cumulative cost often exceeded ¥2 500 000 ($16 844). In contrast, the average household income in Japan in 2022 is ¥5 242 000 ($35 316), highlighting a significant economic barrier to ART accessibility. ⁵

Recognizing the financial challenges associated with ART, several countries have introduced insurance policies or financial support to improve accessibility. Studies from regions with ART insurance coverage have consistently reported increased utilization across all age groups following policy implementation. ⁶ To address these economic barriers and mitigate the impact of declining birth rates, the Japanese government introduced insurance coverage for ART in April 2022. This policy provides coverage for women aged <43 years at the initiation of treatment. Notably, demographic data from 2022 revealed a peak in treatment cycles among 42‐year‐old patients, suggesting a behavioral shift in response to the age restriction. ¹

However, despite the expansion of insurance coverage, its effects on ART accessibility and treatment patterns remain poorly understood. While evidence from the United States suggests that insurance coverage may lead to increased ART utilization, lower pregnancy and multiple birth rates, and fewer embryos transferred per cycle, ⁷ extrapolating these findings to Japan requires the consideration of country‐specific factors, including reimbursement schemes, regulatory constraints on age and cycle limits, and broader demographic trends.

Prior to the implementation of insurance coverage, our research committee conducted a national survey (“Survey on the Implementation of Technological Innovations in ART” [IZANAMI project]) to evaluate the adoption of ART‐related technologies in Japan. ⁸ To assess the impact of insurance coverage on ART accessibility, we conducted a follow‐up survey targeting facilities that participated in the previous study. This study aimed to comprehensively evaluate the effects of these policies on ART utilization and patient access in Japan.

METHODS

Methods and timelines for preparing questions, conducting surveys, and gathering information

The current study was conducted as part of the IZANAMI project, a nationwide survey led by the Subcommittee on Assisted Reproductive Technology under the Committee on Reproduction and Endocrinology. This survey aimed to evaluate the impact of insurance coverage on ART accessibility and patient demographics in Japan. An online survey was administered between December 1, 2023, and January 30, 2024. To maximize participation, multiple reminders were sent via email and direct individual contact. The survey targeted 427 ART facilities that participated in a baseline study conducted before the implementation of insurance coverage. ⁸ , ⁹ , ¹⁰ , ¹¹

Survey content

The survey questionnaire was based on a previous study, which included the following key domains: (i) medical care system—institutional structures and policies related to ART; (ii) reproductive medicine—treatment approaches and clinical practices in ART; (iii) add‐on treatment—utilization and regulation of adjunctive ART interventions; and (iv) patient population dynamics—newly added questions to assess changes in patient demographics following the introduction of insurance coverage (Supporting Information S1). Conversely, questions regarding the use of medical supplies were omitted as they were covered in overlapping surveys. Of the 427 facilities, 283 responded, yielding a response rate of 66.3%.

Assessment of changes in patient demographics

To analyze changes in patient demographics, we designed survey questions addressing the number of patients after insurance coverage, the rate of change in patient numbers before and after insurance coverage, and the proportion of patients in each age group relative to the total patient population before and after insurance implementation. Respondents reported the rate of patient increase or decrease using predefined categories: 70% or less, 80%, 90%, 100%, 110%, 120%, and 130% or higher. Similarly, the proportion of patients in each age group was reported using predefined intervals: 0%–10%, 10%–20%, 20%–30%, 30%–40%, 40%–50%, 50%–60%, 60%–70%, 70%–80%, 80%–90%, and 90%–100%. The number of patients before the insurance coverage was estimated by applying the reported rate of change to the post‐insurance patient count. Age‐specific changes in patient numbers were calculated using the reported proportions before and after insurance coverage. In cases where the sum of age group proportions did not reach 100% within a facility, the reported values were normalized to ensure a total of 100% before calculating the absolute patient counts.

Statistical analysis

We performed statistical analysis by conducting a t‐test using the GraphPad Prism 9 (GraphPad Software, Inc., La Jolla, CA, USA) to examine the differences in patient numbers and percentage changes before and after insurance adoption. A linear regression analysis was performed for the proportion of out‐of‐pocket treatments and patient number change after insurance adoption. All numerical results presented in the text and tables are expressed as the mean values for each parameter. Statistical significance was set at a two‐tailed p‐value <0.05.

Ethical approval

This study was approved by the Institutional Research Ethics Board of Keio University School of Medicine (approval number: 20231126). The collaborating institutions obtained approval from their respective ethics committees to participate in this study.

RESULTS

Changes in patient numbers and age distribution following insurance coverage

To assess whether insurance coverage improved patient access to ART, we analyzed changes in the total number of patients before and after its implementation. The results showed that the total number of patients receiving ART increased by 4.0% (from 217 699 to 226 401) following the introduction of insurance coverage (Table 1).

TABLE 1.

Number of patients by age group and utilization rate before and after insurance coverage.

	All	25–34 years	35–37 years	38–40 years	41–43 years	44+ years
Number of patients before insurance coverage	217 699	44 144	48 081	55 618	45 340	24 516
Number of patients after insurance coverage	226 401	54 253	47 826	55 358	48 441	20 523
Percent change in the number of patients	1.04	1.23	0.99	1.00	1.07	0.84
p‐Value	<0.0001	0.003	0.90	0.91	0.07	0.002

Age‐stratified analysis revealed that the number of patients utilizing IVF within the insurance‐covered age range (25–43 years) increased by 6.6% (193 183–205 878), with a particularly significant increase of 22.9% (44 144–54 253) in the 25‐ to 34‐year age group. In contrast, among patients aged ≥44 years who were outside the coverage range, the number significantly decreased by 16.3% (24 516–20 523) (Table 1). These findings suggest that financial support through insurance coverage improved patient access to ART. However, among those outside the coverage criteria, it may have also influenced the decision to discontinue treatment.

Impact of facility location on ART access after insurance coverage

Several factors, including facility location, proportion of out‐of‐pocket treatments, and facility size, are likely to influence patient access to ART. To evaluate these effects, we analyzed facility‐level changes in the number of patients following the implementation of insurance coverage. Among the surveyed facilities, 172 experienced an increase in the number of patients, whereas 111 either maintained or experienced a decline.

Geographic factors play a critical role in determining ART utilization, and insurance coverage has the potential to improve ART access. To assess this, we analyzed ART patient trends across different prefectures, considering the population distribution. In the prefectures where the number of patients per facility increased, the average number of responding facilities was 4.79, with an average of 1.43 ART facilities per 100 000 women aged 20–49 years and a pre‐insurance patient count of 2835. ¹² Conversely, in prefectures where patient numbers per facility decreased, the respective values were 9.0 facilities, 1.73 facilities per 100 000 women, and 8467 patients, indicating that prefectures with a higher number of patients tended to have smaller‐scale facilities (Figure 1a).

FIGURE 1.

Change in the number of patients by region before and after insurance coverage. (a) Number of patients before and after insurance coverage by prefecture. Pink indicates a higher increase, and blue indicates a lower increase. (b, c). Rural areas (red) exhibited a significantly higher increase in the number of patients after insurance coverage compared to the three largest metropolitan areas (yellow). *p < 0.05.

To further explore the impact of geographical distribution, we classified the regions into three major metropolitan and non‐metropolitan regions. The metropolitan areas included the Tokyo (Tokyo, Kanagawa, Chiba, and Saitama), Nagoya (Aichi, Gifu, and Mie), and Osaka regions (Osaka, Hyogo, and Kyoto) (Figure 1b). A comparative analysis of patient growth rates revealed that the increase in patient numbers was significantly higher in non‐metropolitan regions than in the three major metropolitan areas (mean difference: 0.07; 95% confidence interval [CI]: 0.0–0.1; p = 0.03) (Figure 1c).

Do out‐of‐pocket payments affect ART accessibility?

Out‐of‐pocket payments impose a significant financial burden on patients and may influence ART utilization rates. Our previous study ¹³ demonstrated that large‐scale facilities that perform more than 2000 oocyte retrieval cycles annually tend to have a higher proportion of out‐of‐pocket treatments. In this study, we analyzed facility‐level data on out‐of‐pocket treatment utilization. The results showed that among all facilities, four operated entirely on an out‐of‐pocket basis (100%), seven had an 80% out‐of‐pocket rate, four had a 60% rate, 29 had a 40% rate, 203 had a 20% rate, and 36 offered only insured ART services (0%) (Figure 2a). When stratifying facilities by metropolitan and non‐metropolitan regions, the proportion of facilities offering more than 40% out‐of‐pocket treatment was higher in the three major metropolitan areas (22.1%, N = 34) than in the rural regions (8.5%, N = 11) (Figure 2b,c).

FIGURE 2.

Distribution of out‐of‐pocket treatment utilization and patient growth by region. Proportion of facilities offering out‐of‐pocket treatment in (a) all facilities, (b) the three largest metropolitan areas, and (c) rural areas. Out‐of‐pocket treatment utilization rates are categorized as 0% (blue), 20% (red), 40% (green), 60% (purple), 80% (orange), and 100% (black). Correlation analysis between out‐of‐pocket treatment utilization rates and patient number growth in (d) all facilities, (e) major metropolitan areas, and (f) rural areas.

Notably, facilities that experienced a decline in patient numbers (N = 111) had a significantly higher proportion of out‐of‐pocket treatments (20.7%) than those that experienced an increase in the number of patients (N = 172, 12.2%). This finding suggests an inverse correlation between the proportion of out‐of‐pocket treatments and patient growth. To further examine this association, we conducted a correlation analysis across all facilities. The results confirmed a significant negative correlation between the proportion of out‐of‐pocket treatments and the patient growth rate (Y = −0.001176 × X + 1.105, p = 0.0245) (Figure 2d). This trend was particularly pronounced in urban areas, where the negative correlation was stronger (Y = −0.001864 × X + 1.118, p = 0.0025) (Figure 2e), with only 41.1% (N = 14) of the facilities offering more than 40% out‐of‐pocket treatments experiencing an increased number of patients. Contrary to expectations, no such correlation was observed in rural areas (Y = 0.0003616 × X + 1.079, p = 0.6810) (Figure 2f), and 72.7% (N = 8) of facilities providing more than 40% of out‐of‐pocket treatments still exhibited patient growth. These findings suggest that facilities with higher reliance on out‐of‐pocket payments tend to experience lower patient retention rates, particularly in urban areas. However, this trend was not observed in rural regions, indicating that local accessibility and availability of alternative treatment options may influence patient decision‐making in ART utilization.

DISCUSSION

The introduction of insurance coverage for ART has improved treatment accessibility, particularly for patients within the covered age range, while concurrently reducing utilization among those outside the eligibility criteria. Additionally, a higher proportion of out‐of‐pocket treatments correlated with a significantly lower patient growth rate, underscoring the persistent impact of financial burden on ART utilization, especially in high‐volume facilities. Notably, the effect of insurance coverage was more pronounced in non‐metropolitan regions, where the number of patients increased at a significantly higher rate than in the three largest metropolitan areas. This finding highlights the role of financial assistance in expanding treatment options for younger individuals and mitigating geographical disparities in ART access.

Prefectures with a greater increase in the number of patients tended to have fewer facilities and patients before the policy change, highlighting the role of financial assistance in mitigating geographical barriers to ART access. Importantly, the lower number of ART patients in certain prefectures was not solely attributable to smaller populations, as these regions also had fewer ART facilities per capita, underscoring the structural disparities in ART accessibility. Previous studies have shown that greater distances to medical facilities are associated with lower treatment continuation rates. ² These findings suggest that insurance coverage facilitates ART use in previously underserved populations.

Large‐scale clinics with high oocyte retrieval volumes are often perceived as more attractive to patients because of the cost‐reducing effects of insurance coverage. However, our previous study found that patients tended to concentrate in mid‐sized facilities handling 201–500 oocyte retrieval cycles per year rather than in large‐scale clinics, ¹³ potentially because of the higher proportion of out‐of‐pocket treatments in larger facilities. In the present analysis, the impact of the financial burden varies by region. Although a higher proportion of out‐of‐pocket treatments was significantly associated with suppressed patient growth in urban areas, no such correlation was observed in rural regions. This suggests that in metropolitan areas where multiple ART clinics are available, patients are more selective and prefer facilities with lower financial burdens. In contrast, in non‐metropolitan regions, patients favored clinics that offered a balance between accessibility and operational scales.

Insurance coverage for ART may impact not only treatment accessibility but also clinical outcomes. Our findings demonstrated a significant increase in ART utilization among patients within the covered age groups following the introduction of insurance coverage. These results align with those of previous U.S. studies conducted in 2002, ⁷ which showed higher ART utilization rates in states with comprehensive insurance coverage than in those with partial or no coverage. In addition, ART utilization increased significantly after the introduction of insurance coverage in New Jersey and Connecticut. ⁶ Regarding the clinical outcomes of ART, a German study reported a 54% decrease in the number of births after ART per 1000 insured individuals after insurance coverage for ART was reduced from full to partial reimbursement in 2004, suggesting that reduced financial support may adversely affect treatment outcomes. ¹⁴ In Japan, even before the introduction of ART insurance coverage in 2022, the government implemented financial support for infertility treatment. Notably, in 2021, income restrictions for receiving ART subsidies were removed, resulting in increased treatment cycles and live births compared to the previous year. ¹⁵ Thus, appropriate financial assistance, regardless of insurance status, appears to enhance ART outcomes. Moreover, insurance coverage may influence treatment continuation rates. A U.S. study found that, compared to states with comprehensive mandatory coverage, the likelihood of treatment discontinuation was 46% higher in states with partial insurance coverage and 26% higher in states with no insurance coverage. ² Collectively, our findings suggest that insurance coverage contributes not only to reducing financial burdens but also to improving access, clinical outcomes, and treatment continuation in ART. Further research is warranted to assess the long‐term effects of insurance coverage on treatment continuity and clinical outcomes.

However, the effect of insurance coverage on ART outcomes remains controversial. Jain et al. reported that although insurance coverage improved the safety of ART by reducing the number of embryos transferred per ET, thus decreasing the rate of multiple pregnancies, it also resulted in a decline in the overall birth rates. ⁷ In contrast, Peipert et al. demonstrated that in states with mandatory comprehensive IVF insurance coverage, live birth rates increased significantly by approximately 2%, ¹⁶ highlighting conflicting findings. These discrepancies may be attributed to differences in the age distributions of the patient populations included in each study. Specifically, the proportion of insured patients aged ≥42 years in the 2018 study ¹⁶ was only 4.0%, whereas in the 2002 study, ⁷ 9.4% (131 of 1394 cycles) of ET involved patients aged 41–45 years. Therefore, a higher proportion of older patients accessing treatment through insurance coverage in the 2002 study ⁷ could have negatively influenced the overall treatment outcomes. These findings suggest that the effect of insurance coverage on ART outcomes is influenced not only by the availability of insurance but also by patient age distribution and treatment practices.

Nevertheless, our study revealed a significant decline in ART utilization among patients outside the insurance‐covered age range, suggesting that insurance eligibility may negatively influence patients' decisions to continue treatment. Given the limited success rates of ART in older patient populations, ¹⁷ , ¹⁸ , ¹⁹ the UK's National Institute for Health and Care Excellence (NICE) guidelines recommend limiting insurance coverage to a single IVF cycle for women aged 40–42 years. ²⁰ In contrast, countries facing rapidly declining birth rates, such as South Korea, have removed age restrictions from insurance coverage since 2019. ²¹ In Japan, insurance covers up to three ET cycles for women aged 40–42 years, whereas those aged ≥43 years are excluded. However, this approach presents two significant challenges. First, Japan calculates treatment limits based on the number of ET cycles, although additional retrieval cycles may increase pregnancy potential, highlighting the need for further assessment of appropriate criteria. Second, the availability and acceptability of oocyte donations differ between countries, influencing patients' reproductive options. Although determining the appropriate insurance coverage criteria must be grounded in scientific evidence, promoting reproductive health and rights through education and accurate information dissemination regarding the effectiveness and limitations of ART is essential, particularly for older patients.

Limitation

A key limitation of this study is that it was designed as an institutional survey focusing on the healthcare system, reproductive medicine, IVF add‐on treatment, and changes in the number of patients rather than treatment outcomes, making it difficult to assess how insurance coverage influenced ART success rates (i.e., live birth and multiple pregnancy rates). Additionally, individual patient factors, such as residential location, income, education, number of children, and socioeconomic status, which may affect ART utilization, were not accounted for. Given that previous research has shown that patients living more than 50 miles (approximately 80 km) from an ART facility are less likely to continue treatment after an initial failure, geographical barriers may still play a role. ² However, because Japan's health insurance system is not regionally structured, patients may seek treatment outside their residential areas, making it difficult to determine whether changes in patient numbers reflect regional characteristics. It is necessary to establish a treatment plan by the time patients reach the age of 42 years and 11 months. However, if patients reach the age of 43 under the corresponding plan, they remain eligible for insurance coverage for one treatment cycle. Consequently, it was difficult to clearly distinguish between insurance‐covered and out‐of‐pocket treatment in the data for patients aged 43. Further research incorporating individual‐level data is required to better understand the broader implications of insurance coverage on ART accessibility and utilization.

CONCLUSION

The implementation of insurance coverage for ART has improved accessibility, particularly among individuals aged <35 years and those residing in non‐metropolitan areas. In urban regions, facilities with a higher proportion of out‐of‐pocket treatments exhibited significantly lower patient growth rates, whereas in rural areas, no clear correlation between out‐of‐pocket treatment rates and patient growth was observed, suggesting that regional disparities in healthcare accessibility may influence patient choices. Our results indicate that financial support plays a critical role in alleviating economic and geographical barriers, thereby expanding ART use among populations that previously had limited access to these services.

AUTHOR CONTRIBUTIONS

Aika Wada: Conceptualization; investigation; writing – original draft; methodology; writing – review and editing; software; data curation; resources. Mitsutoshi Yamada: Conceptualization; investigation; writing – original draft; methodology; validation; visualization; writing – review and editing; software; project administration; data curation; resources. Hiromitsu Shirasawa: Writing – review and editing; validation. Seung Chik Jwa: Validation; writing – review and editing; software; methodology; investigation. Keiji Kuroda: Validation; writing – review and editing. Miyuki Harada: Supervision; writing – review and editing. Yutaka Osuga: Supervision; writing – review and editing.

CONFLICT OF INTEREST STATEMENT

The authors declare that they have no conflict of interest. Dr. Seung Chik Jwa is an Editorial Board member of JOGR and a coauthor of this article. To minimize bias, he was excluded from all editorial decisions related to the acceptance of this article for publication.

Supporting information

Data S1. Questionnaire.

Wada A, Yamada M, Shirasawa H, Jwa SC, Kuroda K, Harada M, et al. Impact of insurance coverage on access to assisted reproductive technology: A nationwide survey in Japan (the IZANAMI project). J Obstet Gynaecol Res. 2025;51(4):e16292. 10.1111/jog.16292

DATA AVAILABILITY STATEMENT

Data supporting the findings of this study are available upon request from the corresponding author. The data are not publicly available because of privacy and ethical restrictions.