Out of pocket expenditure incurred by couples seeking infertility services at tertiary level facilities in India

The study was conducted by the department of Operational and Implementation Research, ICMR-National Institute for Research in Reproductive and Child Health (ICMR NIRRCH), Mumbai, Maharshtra, India. Ethical approval from all the study sites with all translated versions of the participant information sheet (PIS) and consent forms was obtained before study initiation. Using a convenience sampling method and willingness to collaborate, five healthcare facilities—three from the public sector [Postgraduate Institute of Medical Education and Research (PGIMER) Chandigarh, Sree Avittom Thirunal Hospital (SAT Hospital), Thiruvananthapuram, Maulana Azad Medical College (MAMC), New Delhi] and two private facilities [Sri Ramachandra Institute of Higher Education and Research (SRIHER), Chennai; Jawaharlal Nehru Medical College (JNMC), Wardha] were selected which represented different geographical regions of India. Considering the mean out-of-pocket expenditure for infertility to be ₹144393 (±130943) [US $1,739.07 (±US $1,577.52)] 8 and assuming effect size=0.20 with α error probability of 0.05 at 80% power, the sample size estimate was 100 per site. Accordingly, a total of 500 participants were included in the study. Infertile couples who were seeking treatment up to IUI were enrolled in the study after written informed consent over a period of 8 months. These cases were selected such that they had been diagnosed with only one factor of infertility namely polycystic ovarian syndrome (PCOS), endometriosis, tubal factors, uterine factors, and male infertility. Couples with idiopathic infertility and multiple factors of infertility were excluded from the study, as it seemed difficult to segregate the expenditure for different factors from patients’ perspectives. Data on out-of-pocket expenditure were collected by trained researchers using a structured questionnaire where tools were designed to capture the data from patients’ perspectives. A standard tool was modified to ensure the capture of all expenditure at various stages of seeking care for infertility. 9 The details on the expenditure obtained from the couple’s interviews were validated with the actual bills of expenditure. The data of one year time period was collected starting from April 1, 2022 to March 31, 2023. Out-of-pocket expenditure related to infertility treatment was systematically categorised into three distinct cost components to provide a clearer understanding of the financial burden faced by couples. The first component, direct medical costs, includes the most immediately visible expenses such as registration fees, consultations with specialists, diagnostic investigations, medications, and the procedures involved in the treatment itself. The second component, non-medical costs include costs related to travel costs associated with treatment, such as transportation and accommodation, as well as food expenses incurred during treatment cycles. And the third component, indirect costs, captures the often-hidden economic impact of infertility treatment. 10 This includes lost wages due to missed work for both the patient and any accompanying person during the treatment process. The indirect costs were calculated using human capital approach which assigns a monetary value to time lost from work based on the income of the individuals affected. To estimate the cost of indirect costs, participants were asked to report their monthly income and for salaried individuals, the monthly income was divided by the number of working days in a month to obtain the daily wage. Then the total indirect cost was then calculated using the formula: Indirect cost = Number of workdays lost × daily wage rate Only patients who had undergone infertility diagnosis and treatment up to IUI (excluding IVF) and met the inclusion criteria were enrolled. Data on expenses incurred in the previous year was collected. The collected data were cleaned and analysed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp.; 2011; Armonk, NY, USA) and Microsoft Excel (version 2016). Mean and median (in cases of skewed data) were computed. The burden of catastrophic health expenditure was also analysed and the threshold for catastrophic health expenditure was taken. Reported costs were recorded in Indian Rupees (INR) and subsequently converted into US Dollars (USD) using an exchange rate of ₹83 per US$ 1. As per WHO recommendations, catastrophic health expenditure was considered as 40% of annual household consumption expenditure without the food as recommended by the WHO 11 ( Supplementary Material ). Supplementary Material

The study population primarily comprised female participants (406/500) with a mean (SD) age of 30 (4.4) years, while males (n=94) averaged 34 (4.67) years. Employment was reported among all male participants compared to only 49 (17%) of females, with the rest (n=357, 83%) identified as homemakers. The average monthly family income was ₹31,089 (±₹24,721) (US $374.6±US $297.8), lower among those attending public facilities. Most couples (n=365, 73%) reported primary infertility, with an average of 6 years since marriage and 4 years of treatment-seeking, having visited at least three health facilities. Comorbid hypothyroidism was more prevalent in females (n=95, 24%), while males showed higher rates of tobacco (n=15, 16%) and alcohol use (n=31, 33%). PCOS was the most common cause diagnosed among enrolled couples (n=190, 38%) followed by tubal factor (n=109, 22%) and male infertility (n=98, 19.6%). Endometriosis and uterine factor were identified in 53 (10.6%) and 50 (10%), respectively. The median annual out-of-pocket expenditure for infertility treatment for selected factors (endometriosis, male infertility, PCOS, tubal factor and uterine factor) are presented as median (IQR) in Table I . Annual out-of-pocket expenditure on infertility (median (IQR)) categorised by aetiology and type of facility (public/private) Costs are in INR (conversion rate to USD; 1USD=INR83) Participants without insurance incurred significantly higher out of pocket expenditure by ₹6,919 (US83.4) (2118 -11720), and those with comorbidities spent ₹2,593 (US $31.2) more (both P< 0.05). IUI cycles were associated with an increased out of pocket expenditure of ₹2,668 (US $32.1; P= 0.017), while borrowing money also increased out of pocket expenditure (₹2,171 or US $26.2; P= 0.063). PCOS was linked to reduced out of pocket expenditure (₹2,004 or US $24.1; P= 0.080), and treatment at private facilities had higher out of pocket expenditure, though not statistically significant. Other factors, including duration since marriage, treatment duration, type of infertility, per capita income, and distance from residence, did not show any significant association with out-of-pocket expenditure ( P> 0.05). Among Direct Healthcare Costs, median spending on surgical procedures was ₹3,002 (US $36.2) and on investigations ₹4,025 (US $48.5). About 35% of participants underwent surgeries, mostly in public facilities, with median costs of ₹3,500 (US $42.2) for HSG and ₹3,250 (US $39.2) for laparoscopy. The study found that 64.8% (n=324) of patients underwent IUI, with the highest out of pocket expenditure spent on direct health costs primarily on medications. Medication costs were nearly double in private facilities compared to public ones. Indirect costs were incurred by n=276 (55.2%) of couples, mainly due to travel and accompanying persons. Among those incurring indirect costs, n=190 (69%) were patients attending private facilities and n=86 (31%) were from government facilities. The average distance travelled for treatment was 57 km (range: 3 km to 1,180 km), with public facilities generally located farther than private ones. Detailed costs of IUI are given in Table II . Distribution of cost for intrauterine insemination The study found 297 (59.4%) couples undergoing infertility treatment incurred catastrophic expenditure out of which 310 (62%) couples belonged to public sector and 190 (38%) couples from private sector. Endometriosis and uterine factor cases, requiring costly surgical interventions, and IUI treatments (n=275, 55% patients) were major contributors to higher out of pocket expenditure and Catastrophic expenditure. Only 5 (1%) had insurance, while 20 (44%) relied on loans or borrowing for treatment expenses. A binary logistic regression analysis was performed to identify factors associated with catastrophic health expenditure (CHE) among patients undergoing infertility treatment. Patients with any co-morbidities such as diabetes, hypertension, or thyroid conditions had significantly higher odds of experiencing Catastrophic expenditure [Odds ratio (OR)=1.612; 95% confidence interval (CI): 1.064–2.443; P= 0.024] as compared to those who did not have any co morbidity. Similarly, patients who had undergone IUI cycles had significantly greater odds of Catastrophic expenditure compared to those who had not (OR=1.882; 95% CI: 1.190–2.976; P= 0.007). Lower per capita income (< ₹59400) was strongly associated with increased risk of Catastrophic expenditure (OR=3.438; 95% CI: 2.269–5.210; P< 0.001). Although marginally significant but patients who visited more than three clinics had higher odds of Catastrophic expenditure compared to those who visited three or more (OR=1.540; 95% CI: 0.988–2.400; P= 0.056). Other variables, such as cause of infertility (PCOS or Others), type of facility (public vs . private), insurance coverage, financial support, marital duration, treatment duration, type of infertility, and distance from residence, did not show significant associations with Catastrophic expenditure ( Table III ). Determinants of catastrophic health expenditure

This study highlights the economic burden associated with infertility care in India, where treatment is mostly financed through out of pocket expenditure. The annual median out-of-pocket expenditure for infertility treatment for most common factors (Endometriosis, Male Infertility, PCOS, Tubal Factor and Uterine Factor) in India was calculated to be ₹11317 (IQR: 4801, 19513), with higher direct medical costs in private facilities and non-medical costs in public hospitals. Within direct medical costs, expenditure was driven not only by medicines but also by diagnostic investigations such as ultrasonography, hysterosalpingography, and laparoscopy, which form an essential part of infertility management. These findings are consistent with existing evidence from low- and middle-income countries (LMICs), where infertility care is largely dependent on OOPE. A systematic review by Njagi et al 10 , (2023) reported that in many LMIC countries, the direct medical costs paid by patients for infertility treatment are often higher than the GDP per capita, making it unaffordable for most people, considering that the income of many people is below the national average. Even in high income country like the US, the median out-of-pocket expense as reported by Wu et al 11 , (2014) was US $5,338, which corresponds to approximately ₹1,09,162 when adjusted for purchasing power parity (PPP conversion factor: 1 US$=₹20.46, World Bank 2022), 12 highlighting that infertility treatment imposes a considerable financial burden globally, irrespective of income setting. This is further supported by global evidence showing that infertility care involves multiple cost components, including repeated procedures and indirect productivity losses, which together increase the overall economic burden, particularly in LMICs. 13 The aetiology of infertility also has a bearing on expenditure. Endometriosis, a major contributor to infertility is known to affect a significant proportion of reproductive aged women often requires costly diagnostic and surgical interventions. 14 , 15 Male infertility contributes substantially to infertility burden in India and often requires hormonal treatment and diagnostic evaluation which increases the costs. 4 , 16 Polycystic ovary syndrome (PCOS), a common endocrine disorder with wide prevalence, requires comprehensive long-term management. 17 , 18 Tubal factor infertility is also associated with significant diagnostic and procedural costs. 19 Although intrauterine insemination (IUI) is recommended as a cost-effective first-line treatment 6 , repeated cycles and associated indirect costs contribute substantially to the overall financial burden. Infertility diagnosis and management in India is very heterogeneous in absence of standard technical and operational guidelines. This along with poor health systems preparedness to address some common causes of infertility such as PCOS 20 further adds to the diagnostic and management heterogeneity. Health care providers are in constant need for training, be it newer areas like infertility that has not formally been introduced in public health sector in India 16 , 21 or even a very long established program like cancer screening that has not been optimised in terms of coverage undermining the need for strengthening. 22 Furthermore despite the inclusion of essential drugs under public health standards their inconsistent availability in public facilities results in additional out-of-pocket spending. Drugs like, letrozole, metformin, and HCG, were not available at public facilities forcing patients to buy them out-of-pocket. Drugs like clomifene citrate and Inj. FSH are not part of the essential drug lists and many investigations are not covered by pmjay which are opd based such as usg diagnostic Hsg/laproscopy, further increasing out of pocket expenditure. A major finding of this study is the high proportion of couples experiencing catastrophic expenditure. This aligns with evidence on inadequate financial protection in health care, which highlights that high OOPE can lead to distress financing and impoverishment. 9 , 23 The low coverage of insurance coverage and reliance on borrowing further emphasise the economic hardship associated with infertility care. Evidence from India shows that publicly financed schemes such as Ayushman Bharat Pradhan Mantri Jan Arogya Yojana provide substantial financial risk protection, with near-zero out-of-pocket expenditure among beneficiaries, while uninsured individuals continue to bear a significant financial burden. 24 Additionally, the increased likelihood of CHE among individuals with co-morbidities and lower income underscores the compounded nature of financial risk. This study has some limitations. Since it was conducted in only five tertiary hospitals, the findings may not represent all infertile couples, especially those seeking care in primary or secondary health care facilities. Individual factor related costs were calculated, hence if couples have multiple factors the expenses may increase proportionately. Also these expenses were in the defined window of one year in which the data was collected and may not actually represent the entire picture of OOPE. There is a potential of recall bias which was addressed by verifying the actual bills in almost all cases. Expenses for IVF were collected and separately analysed that are being documented in a separate manuscript. In conclusion, infertility care in India imposes a substantial financial burden on affected couples, with a high risk of catastrophic expenditure. Addressing these challenges requires strengthening health financing mechanisms, improving service delivery, and prioritising infertility care within the public health system. शोध-संदेश भारत में बांझपन एक बढ़ती हुई प्रजनन स्वास्थ्य समस्या है, जिसे राष्ट्रीय स्वास्थ्य कार्यक्रमों में अभी तक पर्याप्त रूप से शामिल नहीं किया गया है। इसके निदान एवं उपचार के लिए दंपत्तियों को प्रायः उच्च स्तर की स्वास्थ्य सेवाओं का सहारा लेना पड़ता है, जिससे उन पर जेब से होने वाला व्यय काफी बढ़ जाता है। प्रस्तुत अध्ययन में एंडोमेट्रियोसिस, पुरुष बांझपन, PCOS, ट्यूबल एवं गर्भाशय संबंधी कारणों के लिए उपचार प्राप्त करने वाले दंपत्तियों के व्यय का आकलन किया गया, जिसमें जांच, उपचार एवं IUI से संबंधित लागत शामिल है। अध्ययन से स्पष्ट हुआ कि बांझपन का उपचार दंपत्तियों पर महत्वपूर्ण आर्थिक बोझ डालता है। इस स्थिति में समान रूप से स्वास्थ्य सेवाओं की उपलब्धता सुनिश्चित करने हेतु बीमा कवरेज को मजबूत करना तथा सार्वजनिक क्षेत्र में निवेश बढ़ाना आवश्यक है।