Intro
The average cost to couples undergoing in-vitro fertilization (IVF) approaches $25,000 ( 1 ). While this cost alone may already be prohibitive for many US households, time spent pursuing care is an additional source of potential financial burden by way of lost wages and other economic hardships. Time spent on care may also represent a significant social and mental burden. These costs are directly felt by the couple and may not be mitigated by insurance coverage or other external assistance ( 2 ).
The financial burden of fertility care has been previously well characterized as a possible barrier to treatment. Individual income significantly affects the probability of seeking fertility care ( 3 ), with patients of higher socioeconomic status (SES) more likely to seek treatment for infertility, even in states with comprehensive insurance coverage for such services ( 4 ). Once fertility treatment is initiated, SES is independently associated with the amount of money one will spend on their care ( 5 ). The impact of time costs have been previously investigated as an assessment of how travel time impacts decision making ( 6 ), and how time costs in a French population impact couples’ impressions and satisfaction ( 7 ). However, time costs have not been previously evaluated prospectively over time.
In contrast, time spent pursuing care for other conditions have been measured. Yabroff et al. reviewed the time costs associated with 11 of the most common types of cancer in the United States and found that time costs ranged from 18 to 368 hours during initial treatment and 99 to 512 hours during end-stage treatment. Based on the median wage of $15.23, time spent pursuing initial cancer care translated to an estimated $2.3 billion of lost wages ( 8 ).
In a cohort of couples seeking fertility care prospectively followed for 18 months, diaries were used to estimate the time spent pursuing reproductive health care, the primary components of this time, and the degree to which fertility-related stress was associated with time spent pursuing care. Using multivariable regression modeling we estimate the independent factors associated with time spent pursuing care and fertility-related stress, hypothesizing that time spent on fertility care will be associated with type of treatment, socioeconomic factors, and fertility-related stress.
Methods
A detailed description of the cohort and methods has been previously published ( 1 ). Briefly, women were recruited into the study from 8 participating reproductive endocrinology clinics after the female partner presented for fertility treatment, and were followed for 18 months. Of 809 women who met inclusion criteria, 437 (54%) agreed to participate. Women included were heterosexual, English-speaking, and were attending their first visit to the recruiting reproductive endocrinology clinic. Women were excluded if they had prior IVF, hysterectomy, sterilization procedure, or were seeking consultation for recurrent miscarriages. Women receiving other prior treatments for infertility were not excluded. Among this group, 319 (73% retention) completed diaries detailing the time spent pursuing fertility care. Only women with compete data regarding demographics, diagnosis, treatment, outcome, and time costs were included in the analysis. The Institutional Review Board at the University of California, San Francisco approved the study protocol; all subjects provided written consent.
Time spent pursuing fertility treatment was directly determined by patient responses in diaries, and includes time spent by both male and female partners. Subjects were asked how many hours they spent on the following tasks: visits or procedures with doctors or other providers, traveling, telephone calls (making appointments, getting test results, talking with insurance companies) and other tasks (including picking up drugs, recovery time, attending support group meetings and internet searches).
Fertility stress was measured with four questions asking participations to rate how stressful each of the following had been over the past 18 months: discussing fertility treatments with their partner, dealing with fertility treatments, overall how stressful as an individual, and overall how stressful as a couple. Each item was rated on an 11-point scale from 0 (not at all stressful) to 10 (most stressful thing in the past 18 months). The mean of the four items was used as an indicator of fertility stress (Cronbach’s alpha = 0.85).
Fertility treatment use was categorized based on the highest treatment intensity utilized: no treatment, ovulation induction medications only, intrauterine insemination (IUI) with ovulation induction only, and in vitro fertilization (IVF) ( 9 ). Couples transitioning from a lower intensity of treatment to a higher intensity were included in the highest intensity treatment group. Couples were also divided by those receiving cycle-based therapy (CBT) and those receiving non-CBT. Couples receiving non-CBT included those that were treated with expectant management, behavioral modification, or a one-time surgical procedure, such as laparoscopy for treatment of endometriosis or hysteroscopy for uterine fibroids. Additionally, in cases of male factor infertility, male partners may have received interventions including medications or surgery, but these data were not available.
Female highest level of education, employment status, annual household income, female age, female race/ethnicity, previous child, duration of infertility, previous treatment, marital status, and insurance coverage for fertility services was determined through questionnaires. Education was dichotomized to less than college graduate or college graduate. Household income was categorized as <$60,000/year, $60,000–$99,999, $100,000–$149,999, ≥$$150,000/year, and refusal to declare income. Because of low numbers of subjects in the lowest 2 income subgroups, we combined these groups for regression models. Race and ethnicity were determined by female partner self-report and categorized to white, black, Hispanic, Asian, and other, according to US Census guidelines ( 10 ). Due to low numbers in several racial and ethnic minority groups, race was dichotomized to white or non-white. The etiology of infertility was obtained through medical record abstraction and classified as no known etiology, male factor only, female factor only, and both male and female factors.
Descriptive statistics were used to summarize cohort characteristics. Linear regression was used to explore bivariate relationships between predictor variables and outcomes. Multivariable linear regression analysis was performed to determine the independent effect of age, marital status, race, education, income, previous child, duration of infertility, employment status, insurance coverage for fertility care, and infertility diagnosis on the time spent pursuing fertility treatment. An additional multivariable linear regression model was developed to determine the relationship between time spent pursuing fertility care and fertility stress. Number of treatment cycles was excluded from these models due to collinearity with treatment intensity. All p-values were based on two-tailed tests, with statistical significance indicated by p < 0.05 (95% confidence interval excluding zero for linear regression models). STATA 11 (Statacorp, College Station, TX, USA) was used for all analyses.
Results
Demographic, socioeconomic, diagnostic, and treatment characteristics of the cohort and their associated time spent over the 18-months study period are shown in Table 1 . The mean time spent on fertility care for all subjects was 125 hours (SD: 128, range: 2 – 751 hours). The average age of the cohort was 35.6 years old (+/− 4.8), 89% were married, 72% were Caucasian, 76% had a college degree, 76% had no previous children, 71% had been treated previously and 60% were employed full time. Time spent on fertility care did not significantly differ by patient age, marital status, household income, insurance coverage, employment status, previous treatment, the duration of infertility, or by male or female factor.
In initial bivariate comparisons, patients with a college degree spent significantly more time pursing treatment versus those without a degree (139 hours vs. 82 hours, p <0.001). Additionally, patients with a previous child spent significantly less time on treatment compared to those without a previous child (133 hours vs. 98 hours, p=.04).
Among all members of the cohort, 80% pursued CBT, with 53% of the cohort using IVF, 23% IUI, and 4% ovulation induction methods. Couples utilizing CBT spent significantly more time pursuing fertility treatment, averaging 142 hours, versus 58 hours for non -CBT couples (p<0.001). Increasing number of cycles was associated with increasing time spent on fertility care: couples using 1–2 cycles averaged 110 hours, those using 3–4 cycles averaged 153 hours and those using over 5 cycles averaged 175 hours (p<0.001). Time spent also differed based on the highest level of fertility treatment utilized: couples using ovulation induction medications averaged 61 hours compared to 107 for IUI, and 162 hours for IVF (p<0.001).
Components of time spent on care, stratified by use or non-use of CBT are shown in Table 2 . Couples using CBT consistently spent more time seeking care. Provider visits consumed the most time for both groups (CBT: 73, SD: 69, range: 0.2 – 353 hours), (non-CBT: 26, SD: 35, range: 1 – 170 hours). Travel time was the second largest category for both groups (CBT: 43, SD: 52, range 0 – 300 hours), (non-CBT: 19, SD: 49, range 0 – 305 hours). Provider visits and travel time combined to account for 82% and 79% of time spent for CBT and non-CBT couples, respectively.
Results of multivariable linear regression analysis, adjusting for age, marital status, race, education, income, previous child, previous treatment, duration of infertility, employment status, insurance coverage, and infertility diagnosis are shown in Table 3 . After multivariable adjustment, women with college degrees spent on average 49 hours more (95% CI: 14 to 83) pursuing fertility care than those without (p=0.006). Compared to those not undergoing CBT, couples undergoing IUI and IVF spent 40 hours (95% CI: -4 to 83, p=0.07) and 97 hours (95% CI: 60 to 135, p<0.001) more, respectively. When controlling for other variables, previous child was not significantly associated with decreased time spent (p=0.28).
Bivariate analysis demonstrated a direct relationship between time spent pursuing fertility care and fertility stress ( Table 4A ); subjects who spent greater than 160 hours on care were significantly more likely to experience fertility related stress (β= 12.8, 95% CI: 5 to 21, p= 0.002). After adjustment for female age, marital status, race, education, income, insurance, employment status, previous child, previous treatment and treatment type, a significant diminution in the strength of this relationship was observed (β= 7.3, 95% CI -2 to 17, p= .12), primarily mediated by the intensity of CBT utilized ( Table 4B ). In fact, pursuing IVF was the only factor independently associated with fertility stress, even after full adjustment for sociodemographic characteristics and time spent pursuing care (p= .04).
Discussion
This study prospectively characterizes the time couples spend pursuing fertility care. In this analysis, we observed that patients spent an average of 125 hours pursuing treatment. Cost overall is continually cited as a reason why patients choose not to pursue fertility care or discontinue care prior to achieving pregnancy ( 11 , 12 ), and this is true even in countries where infertility services are subsidized ( 13 , 14 ), suggesting a significant impact of indirect and time costs. This phenomenon is not unique to fertility care. A 2007 nationwide survey of cancer sufferers found 8% of all patients and 27% of patients who were ever uninsured delayed or decided not to obtain treatment because of the cost ( 15 ). Direct costs to patients for fertility care have previously been investigated, with median per-person costs ranging from $1,182 for medications only to $24,373 and $38,015 for IVF and IVF with donor eggs, respectively ( 1 ). When discussing the full potential burden posed by fertility care with patients, a clinician can now, in addition to providing patients a reasonable estimate of the direct costs for different treatment options, also give patients a sense of the time burden posed by various forms of treatment. This information will lead to a greater understanding of the true costs of different treatment modalities and may impact a patient’s decision on if and how to proceed.
These data suggest that as the time spent on fertility care increases, there is a trend towards an increase in stress experienced by the patient. Prior studies have found fertility treatment leads to emotional distress, which contributes to high dropout rates among those undergoing CBT ( 16 – 18 ). Additionally, specific diagnosis and prognosis may be related to fertility stress as well, as evidenced by the non-significant trend towards greater fertility stress amongst patients with both male and female factor fertility issues. Our data indicate that this stress may be in part due to the significant time burden faced by these patients. In our bivariate analysis of the relationship between stress and time, those spending over 160 hours pursuing treatment experienced significantly more stress, with an average of 12.8 more stress points in our 100-point scale. This effect on stress appears to reach the criterion of a minimally important difference, using one half standard deviation as an approximation ( 19 ).
There are several limitations to our analysis that are worth noting. While patient reported diaries are an accurate method of obtaining information on time spent on care, patients may neglect to report some aspects of the time they spent pursuing treatment or may overestimate other aspects.. Additionally, 71% of our cohort received previous treatment, and our analysis does not account for this time. Many couples were unsuccessful during the 18 months they were followed, and several of these couples likely continued to pursue additional fertility treatment, and we do not account for this time. We do not account for this time spent pursuing care. Thus, our findings are likely an underestimate of the true time costs associated with fertility care. Also, while we were able to control for which partner carried the infertility diagnosis, we did not control for specific diagnoses within gender, which may carry different time costs. Although a large percentage of couples from the original infertility cohort completed the cost diaries (73%), it is possible that couples completing cost diaries were more or less likely to report time expenses compared to non-respondents. We do not have direct data to assess this question.
Despite these limitations, we were able to evaluate the time spent pursuing several different treatment options for fertility care. This time represents an important and under recognized burden with stressful consequences for patients. Time spent on care varies significantly and independently by treatment modality and SES factors. These data may provide insight to both clinicians and patients regarding the full financial, mental, and social burden of pursuing fertility treatment.
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