One size does not fit all: variations by ethnicity in demographic characteristics of men seeking fertility treatment across North America.

OBJECTIVE: To compare racial differences in male fertility history and treatment. DESIGN: Retrospective review of prospectively collected data. SETTING: North American reproductive urology centers. PATIENT(S): Males undergoing urologist fertility evaluation. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Demographic and reproductive Andrology Research Consortium data. RESULT(S): The racial breakdown of 6,462 men was: 51% White, 20% Asian/Indo-Canadian/Indo-American, 6% Black, 1% Indian/Native, <1% Native Hawaiian/Other Pacific Islander, and 21% "Other". White males sought evaluation sooner (3.5 ± 4.7 vs. 3.8 ± 4.2 years), had older partners (33.3 ± 4.9 vs. 32.9 ± 5.2 years), and more had undergone vasectomy (8.4% vs. 2.9%) vs. all other races. Black males were older (38.0 ± 8.1 vs. 36.5 ± 7.4 years), sought fertility evaluation later (4.8 ± 5.1 vs. 3.6 ± 4.4 years), fewer had undergone vasectomy (3.3% vs. 5.9%), and fewer had partners who underwent intrauterine insemination (8.2% vs. 12.6%) compared with all other races. Asian/Indo-Canadian/Indo-American patients were younger (36.1 ± 7.2 vs. 36.7 ± 7.6 years), fewer had undergone vasectomy (1.2% vs. 6.9%), and more had partners who underwent intrauterine insemination (14.2% vs. 11.9%). Indian/Native males sought evaluation later (5.1 ± 6.8 vs. 3.6 ± 4.4 years) and more had undergone vasectomy (13.4% vs. 5.7%). CONCLUSION(S): Racial differences exist for males undergoing fertility evaluation by a reproductive urologist. Better understanding of these differences in history in conjunction with societal and biologic factors can guide personalized care, as well as help to better understand and address disparities in access to fertility evaluation and treatment.

Implications of employer coverage of contraception: Cost-effectiveness analysis of contraception coverage under an employer mandate.

OBJECTIVES: Mandatory employer-based insurance coverage of contraception in the US has been a controversial component of the Affordable Care Act (ACA). Prior research has examined the cost-effectiveness of contraception in general; however, no studies have developed a formal decision model in the context of the new ACA provisions. As such, this study aims to estimate the relative cost-effectiveness of insurance coverage of contraception under employer-sponsored insurance coverage taking into consideration newer regulations allowing for religious exemptions. STUDY DESIGN: A decision model was developed from the employer perspective to simulate pregnancy costs and outcomes associated with insurance coverage. Method-specific estimates of contraception failure rates, outcomes and costs were derived from the literature. Uptake by marital status and age was drawn from a nationally representative database. RESULTS: Providing no contraception coverage resulted in 33 more unintended pregnancies per 1000 women (95% confidence range: 22.4; 44.0). This subsequently significantly increased the number of unintended births and terminations. Total costs were higher among uninsured women owing to higher costs of pregnancy outcomes. The effect of no insurance was greatest on unmarried women 20-29 years old. CONCLUSIONS: Denying female employees' full coverage of contraceptives increases total costs from the employer perspective, as well as the total number of terminations. IMPLICATIONS: Insurance coverage was found to be significantly associated with women's choice of contraceptive method in a large nationally representative sample. Using a decision model to extrapolate to pregnancy outcomes, we found a large and statistically significant difference in unintended pregnancy and terminations. Denying women contraception coverage may have significant consequences for pregnancy outcomes.

Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.

OBJECTIVE: To identify baseline characteristics of women with unexplained infertility to determine whether treatment with an aromatase inhibitor will result in a lower rate of multiple gestations than current standard ovulation induction medications. DESIGN: Randomized, prospective clinical trial. SETTING: Multicenter university-based clinical practices. PATIENT(S): A total of 900 couples with unexplained infertility. INTERVENTION(S): Collection of baseline demographics, blood samples, and ultrasonographic assessments. MAIN OUTCOME MEASURE(S): Demographic, laboratory, imaging, and survey characteristics. RESULT(S): Demographic characteristics of women receiving clomiphene citrate (CC), letrozole, or gonadotropins for ovarian stimulation were very consistent. Their mean age was 32.2 ± 4.4 years and infertility duration was 34.7 ± 25.7 months, with 59% primary infertility. More than one-third of the women were current or past smokers. The mean body mass index (BMI) was 27 and mean antimüllerian hormone level was 2.6; only 11 women (1.3%) had antral follicle counts of <5. Similar observations were identified for hormonal profiles, ultrasound characterization of the ovaries, semen parameters, and quality of life assessments in both male and female partners. CONCLUSION(S): The cause of infertility in the couples recruited to this treatment trial is elusive, as the women were regularly ovulating and had evidence of good ovarian reserve both by basal FSH, antimüllerian hormone levels, and antral follicle counts; the male partners had normal semen parameters. The three treatment groups have common baseline characteristics, thereby providing comparable patient populations for testing the hypothesis that use of letrozole for ovarian stimulation can reduce the rates of multiples from that observed with gonadotropin and CC treatment. CLINICAL TRIAL REGISTRATION NUMBER: NCT 01044862.

Anatomical and histological equivalence of the human, canine, and bull vas deferens.

INTRODUCTION: Several animal models have been utilized for in-vitro experimentation and surgical training exercises of the vas deferens. The canine model is currently the standard for both in-vivo and ex-vivo study. Due to increasing costs associated with experimentation on canines, and in keeping with the principles of refine, reduce, and replace, a novel model that is cost-effective and easily obtained is desired. We compared morphology of the bull vas deferens to that of the human and the canine. MATERIALS AND METHODS: Bilateral vas deferens tissue from the human (n = 6), canine (n = 6), and bull (n = 5) were compared. Outer diameter (OD), inner diameter (ID), and microscopic measurements of the luminal mucosa and muscularis were then determined from each of these tissues. Histological comparisons were performed by a single pathologist. Data was analyzed using Two One-sided Tests (TOST) Analysis of Equivalence. RESULTS: According to the TOST statistical analysis, the vassal ID was equivalent for all three species. Similarly, equivalent microscopic measurements were noted for both vassal mucosal (human-canine and human-bull) and muscularis thicknesses (canine-bull). Lastly, all three species had similar histological characteristics. CONCLUSIONS: The vas deferens' of the human, canine, and bull are equivalent in many ways, including histological similarities. It is reasonable to conclude that the bull vas could be substituted for the human vas for both in-vitro testing and microscopic vasovasostomy simulation exercises. Specimens are cost-effective, provide ample tissue length, and are easy to obtain.

Trends and determinants of reproductive health service use among young women in the USA.

BACKGROUND: This study explores the current patterns of reproductive health service use among young women in the USA and the changing influence of socio-demographic factors on the types of services used over time. METHODS: The study population, drawn from the two last cycles of the National Survey of Family Growth, consists of women aged 15-24 (n = 2543 in 1995, n = 2157 in 2002). We examined trends in use of 'contraceptive services' and 'other reproductive health services for preventive care' and tested for changes in the patterns of use of these services over time. Logistic regression models were used to further clarify the factors associated with the use of the two types of services in 2002. RESULTS: Results show no difference in the overall use of reproductive health services in the past year but did reveal changes in the type of service sought. Use of services for contraception increased by 10 percentage points (39.3% in 1995 to 49.7% in 2002, P < 0.001), although the use of other services remained stable (53.2% in 1995, 50.2% in 2002, P = 0.14). The patterns of use varied over time, exhibiting growing social disparities. In 2002, the use of contraceptive services depended on women's age, number of partners, personal and mother's level of education, and menstrual problems. The use of other reproductive health services for preventive care varied across women's socio-economic background. CONCLUSION: This study demonstrates increasing social differentials in the use of reproductive health services for preventive care among young women in the USA between 1995 and 2002, a finding which calls for careful monitoring in the context of limited resources.

Emergency contraception.

Emergency contraceptives are methods that prevent pregnancy when used shortly after unprotected sex. Three different emergency contraceptive methods are safe, simple, and widely available in the United States. These are: (1) ordinary combined oral contraceptives containing ethinyl estradiol and levonorgestrel taken in a higher dose for a short period of time and started within a few days after unprotected intercourse; (2) levonorgestrel-only tablets used similarly; and (3) copper-bearing intrauterine devices inserted within approximately 1 week after unprotected intercourse. Emergency contraceptive use is best known for women who have been raped, but the methods are also appropriate for women who have experienced condom breaks, women who did not use any method because they were not planning on having sex, or women who had unprotected intercourse for any other reason. Unfortunately, few women know about emergency contraceptives, and few clinicians think to inform their patients routinely about the option. A nationwide toll-free hotline (1-888-NOT-2-LATE) and a website (http://not-2-late.com) can help women learn about these options. Sharing "family planning's best-kept secret" widely with women could prevent as many as a million unwanted pregnancies annually in the United States.

Cost savings from emergency contraceptive pills in Canada.

OBJECTIVE: To estimate cost savings from emergency contraceptive pills in Canada. METHODS: We modeled cost savings when a single emergency contraceptive treatment was provided after unprotected intercourse and when women were provided emergency contraceptive pills in advance. RESULTS: Each dollar spent on a single treatment saved $1.19--$2.35 (in Canadian currency), depending on the regimen and on assumptions about savings from costs avoided by preventing mistimed births. The dedicated products Preven (Shire Canada, Inc., Oakville, Ontario) and Plan B (Paladin Labs, Inc., Montreal) were cost-saving even under the least favorable assumption that mistimed births prevented today occur 2 years later. Each dollar spent on advance provision of Preven saved $1.24--$12.23, depending on the regular contraception method, on how consistently emergency contraception was used when needed, and on whether mistimed births were averted forever or simply delayed. Plan B was almost always cost-saving, although less so. CONCLUSION: Emergency contraception was cost-saving whether provided when the emergency occurred or in advance to be used as needed. More extensive use of emergency contraception could save considerable medical costs by reducing unintended pregnancies.

Likelihood of conception with a single act of intercourse: providing benchmark rates for assessment of post-coital contraceptives.

Emergency post-coital contraceptives effectively reduce the risk of pregnancy, but their degree of efficacy remains uncertain. Measurement of efficacy depends on the pregnancy rate without treatment, which cannot be measured directly. We provide indirect estimates of such pregnancy rates, using data from a prospective study of 221 women who were attempting to conceive. We previously estimated the probability of pregnancy with an act of intercourse relative to ovulation. In this article, we extend these data to estimate the probability of pregnancy relative to intercourse on a given cycle day (counting from onset of previous menses). In assessing the efficacy of post-coital contraceptives, other approaches have not incorporated accurate information on the variability of ovulation. We find that the possibility of late ovulation produces a persistent risk of pregnancy even into the sixth week of the cycle. Post-coital contraceptives may be indicated even when intercourse has occurred late in the cycle.

Emergency contraception: a review of the programmatic and social science literature.

Many biomedical aspects of emergency contraception have been investigated and documented for >30 years now. A large number of social science questions, however, remain to be answered. In this article, we review the rapidly growing but geographically lopsided literature on this topic. Using computer database searches supplemented by reference reviews and professional correspondence with those active in the field, we gathered literature on the social science and service delivery aspects of emergency contraception published in English up through December 1998, as well as a few unpublished papers from the same time and slightly later, representing regions where published material is practically nonexistent. Methodologically acceptable papers are summarized in our tables and text, and form the basis for suggested improvements in existing emergency contraceptive services. The review also offers ideas for designing new emergency contraception services where they do not yet exist. We conclude by proposing an agenda for further social science research in this area.

Access to emergency contraception.

OBJECTIVE: To evaluate access to emergency contraception among women seeking help from clinicians who registered to be listed on the Emergency Contraception Hotline (1-888-NOT-2-LATE, ie, 1-888-668-2528) and the Emergency Contraception Website (not-2-late.com). METHODS: Two college-educated investigators posing as women who had a condom break the previous night called 200 providers to seek help. RESULTS: Only 76% of attempts resulted in an appointment or telephone prescription from a hotline provider within 72 hours, 14% were failures, and 11% resulted in referrals to other providers not listed on the hotline or website. CONCLUSION: Even under ideal conditions, access to emergency contraception is currently constrained. Although emergency contraception could reduce significantly the incidence of unintended pregnancy and the consequent need for abortion, its potential will not be realized unless women have better access to clinicians who can prescribe emergency contraceptive pills.

Contraceptive failure, method-related discontinuation and resumption of use: results from the 1995 National Survey of Family Growth.

CONTEXT: Half of all pregnancies in the United States are unintended. Of these, half occur to women who were practicing contraception in the month they conceived, and others occur when couples stop use because they find their method difficult or inconvenient to use. METHODS: Data from the 1995 National Survey of Family Growth were used to compute life-table probabilities of contraceptive failure for reversible methods of contraception, discontinuation of use for a method-related reason and resumption of contraceptive use. RESULTS: Within one year of starting to use a reversible method of contraception, 9% of women experience a contraceptive failure--7% of those using the pill, 9% of those relying on the male condom and 19% of those practicing withdrawal. During a lifetime of use of reversible methods, the typical woman will experience 1.8 contraceptive failures. Overall, 31% of women discontinue use of a reversible contraceptive for a method-related reason within six months of starting use, and 44% do so within 12 months; however, 68% resume use of a method within one month and 76% do so within three months. Multivariate analyses show that the risk of contraceptive failure is elevated among low-income women and Hispanic women. Low-income women are also less likely than other women to resume contraceptive use after discontinuation. CONCLUSIONS: The risks of pregnancy during typical use of reversible methods of contraception are considerably higher than risks of failure during clinical trials, reflecting imperfect use of these methods rather than lack of inherent efficacy. High rates of method-related discontinuation probably reflect dissatisfaction with available methods.

PIP: This study computed life table probabilities of contraceptive failure, discontinuation of use, and return to contraceptive use in the US. Data were obtained from the 1995 National Survey of Family Growth (NSFG) among a nationally representative sample of 6867 contraceptive use intervals contributed by women 15-45 years old who began use or resumed use after discontinuation during 1991-95. Analysis was based on Kaplan-Meier product-limit single decrement life table probability methods. Findings indicate that the risk of failure during typical use of reversible methods was 9% within 1 year of starting. Women with continuous lifetime use will experience 1.8 contraceptive failures. Failure rates were 7% for the pill, 9% for the male condom, 8% for the diaphragm, 20% for periodic abstinence, and 15% for spermicides. Failure rates reflect imperfect use. 31% of women discontinued use within 6 months of starting use. 44% discontinued within 12 months. Women using reversible methods continuously will discontinue use nearly 10 times during the reproductive period. Most women resumed use shortly after discontinuation. Low income women had higher risk of unintended pregnancy for all methods and the pill and lower risk of resumption after discontinuation. Hispanics had a higher risk of contraceptive failure for all methods and the condom. Black women had a higher risk of discontinuation of oral pills and condoms.

Should emergency contraceptive pills be available without prescription?

Leading health agencies, including the World Health Organization and the US Food and Drug Administration, consider emergency contraceptive pills (ECPs) safe and effective and have called for better access to them. Yet debate about whether ECPs should continue to be available by prescription only has been limited. After measuring the characteristics of ECPs against criteria developed to assess the necessity for prescription status for drugs generally, we argue that ECPs can safely be marketed over the counter. Professional assistance is not necessary since the woman diagnoses her own need for the pills and takes them herself. ECPs do not need to be adjusted for the individual woman and pose no potential threat of overdose or addiction. There are no contraindications except confirmed pregnancy (in which case the therapy will not work), and monitoring is not necessary. We conclude that prescription requirements that keep ECPs from women provide little, if any, benefit.

Call 1-888-NOT-2-LATE: promoting emergency contraception in the United States.

In 1997, the nonprofit Reproductive Health Technologies Project and the Office of Population Research at Princeton University, together with the communications firm Elgin DDB, planned and executed a mass media campaign to advertise the Emergency Contraception Hotline and more generally to further awareness of emergency contraception as a last chance means of pregnancy prevention in the United State. We produced a variety of public service announcements (PSAs) including television and radio spots in English and Spanish and several print versions adaptable for newspapers and magazines as well as outdoor settings such as billboards, transit shelters, and the sides of buses. Working with local coalitions, we succeeded in placing the PSAs free of charge in six pilot cities. We also generated coverage about the campaign in local and national news outlets. We chronicle the development of the media campaign, discuss the challenges and obstacles faced, and conclude with a review of the principal lessons learned.

Declining cesarean delivery rates in California: an effect of managed care?

OBJECTIVES: We hypothesized that movement from traditional indemnity insurance to managed care in California between 1983 and 1994 would lead to reductions in the rate of cesarean delivery. STUDY DESIGN: We decomposed the frequency of cesarean delivery with each primary diagnosis into the product of the diagnosis rate among all women and the cesarean delivery rate among women with the given diagnosis (conditional cesarean delivery rate). We used logistic regression to estimate the diagnosis and conditional cesarean delivery rates. RESULTS: Adjusted and observed cesarean delivery rates are indistinguishable. Both the diagnosis rates and the conditional cesarean delivery rates contributed to the increase in the cesarean delivery rate between 1983 and 1987. The subsequent decline is attributable to the decline in the repeated cesarean delivery rate. CONCLUSIONS: The increase in managed care in California played no apparent role in the decline in the cesarean delivery rate. With the exception of Kaiser health maintenance organizations, managed care providers and indemnity insurers managed deliveries similarly.

Should emergency contraceptive pills be available without prescription in Europe?

PIP: Although several dedicated products are specifically marketed for emergency contraception in parts of Europe, the method requires a physician's prescription. This article argues that there are no compelling reasons to continue to restrict the method to prescription-only status. The UK's Office of Health Economics has identified the following criteria for determining a drug's need for prescription status: women's ability to self-diagnose, the complexity of self-administration, the need for individualized regimens, the potential for addiction or accidental overdose, the existence of contraindications, and the need to monitor short- and long-term side effects. Consideration of these criteria provides no persuasive arguments for continuing to restrict emergency hormonal contraception to prescription status. Given the 72-hour time limit on use of this method after unprotected intercourse, the requirement of a medical appointment may put this option out of reach of many women who need it. A compromise solution would be to allow women to receive emergency contraception from pharmacists in accordance with an approved protocol rather than over the counter.^ieng

Preventing unintended pregnancy: the cost-effectiveness of three methods of emergency contraception.

OBJECTIVES: This study examined the cost-effectiveness of emergency contraceptive pills, minipills, and the copper-T intrauterine device (IUD) as emergency contraception. METHODS: Cost savings were modeled for both (1) a single contraceptive treatment following unprotected intercourse and (2) emergency contraceptive pills provided in advance. RESULTS: In a managed care (public payer) setting, a single treatment of emergency contraception after unprotected intercourse saves $142 ($54) with emergency contraceptive pills and $119 ($29) with minipills. The copper-T IUD is not cost-effective as an emergency contraceptive alone, but savings quickly accrue as use continues. Advance provision of emergency contraceptive pills to women using barrier contraceptives, spermicides, withdrawal, or periodic abstinence saves from $263 to $498 ($99 to $205) annually. CONCLUSIONS: Emergency contraception is cost-effective whether provided when the emergency arises or in advance to be used as needed. Greater use of emergency contraception could reduce the considerable medical and social costs of unintended pregnancies.

Medical care cost savings from adolescent contraceptive use.

An analysis of the economic benefits of adolescent contraceptive use utilizes information from a national private payer database and from the California Medicaid program to compare private- and public-sector costs and savings. The study estimates the costs of acquiring and using 11 contraceptive methods appropriate for adolescents, treating associated side effects, providing medical care related to an unintended pregnancy during method use and treating sexually transmitted diseases (STDs) and compares them with the costs of using no method. The average annual cost per adolescent at risk of unintended pregnancy who uses no method is $1,267 ($1,079 for unintended pregnancy and $188 for STDs) in the private sector and $677 ($541 for unintended pregnancy and $137 for STDs) in the public sector under the most conservative assumptions. At one year of use, private-sector savings from adolescent contraceptive use range from $308 for the implant to $946 for the male condom; public-sector savings rise from $60 for the implant to $525 for the male condom. Both the use of male condoms with another method and the advance provision of backup emergency contraceptive pills provide additional savings.

PIP: Six previous studies have demonstrated that contraceptive use saves substantial health care dollars in both private and public settings in the US. The present study was the first to focus on the costs and savings of contraceptive use among US adolescent women 15-19 years of age. Through use of data from a national third-party private payer database and from the California Medicaid program, the costs of acquiring and using 11 contraceptive methods appropriate for adolescents, treating associated side effects, providing medical care related to an unintended pregnancy during method use, and treating sexually transmitted diseases (STDs) were calculated and compared with the costs of using no method. Under the most conservative of the three scenarios considered (which included the cost of STDs and lowered the cost of unintended birth to reflect the reported proportions of unwanted and mistimed births), the average annual cost per adolescent at risk of unintended pregnancy who used no method was US$1267 (including $188 for STDs) in the private sector and $677 ($137 for STDs) in the public sector. At 1 year of use, cost savings from adolescent contraceptive use were lowest for the implant ($60 in the public sector and $308 in the private sector) and highest for the male condom ($525 and $946, respectively). Additional savings were conferred both by the use of male condoms with another method and the advance provision of backup emergency contraceptive pills. Policies that reduce the occurrence of adolescent pregnancy and STDs are important for their social and reproductive health benefits. These findings indicate that--in addition--the provision of health insurance coverage for contraception, without substantial out-of-pocket expenditures or deductibles, is highly cost-effective.

The economic value of contraception: a comparison of 15 methods.

OBJECTIVES: The purpose of the study was to determine the clinical and economic impact of alternative contraceptive methods. METHODS: Direct medical costs (method use, side effects, and unintended pregnancies) associated with 15 contraceptive methods were modeled from the perspectives of a private payer and a publicly funded program. Cost data were drawn from a national claims database and MediCal. The main outcome measures included 1-year and 5-year costs and number of pregnancies avoided compared with use of no contraceptive method. RESULTS: All 15 contraceptives were more effective and less costly than no method. Over 5 years, the copper-T IUD, vasectomy, the contraceptive implant, and the injectable contraceptive were the most cost-effective, saving $14,122, $13,899, $13,813, and $13,373, respectively, and preventing approximately the same number of pregnancies (4.2) per person. Because of their high failure rates, barrier methods, spermicides, withdrawal, and periodic abstinence were costly but still saved from $8933 to $12,239 over 5 years. Oral contraceptives fell between these groups, costing $1784 over 5 years, saving $12,879, and preventing 4.1 pregnancies. CONCLUSIONS: Contraceptives save health care resources by preventing unintended pregnancies. Up-front acquisition costs are inaccurate predictors of the total economic costs of competing contraceptive methods.

Teenage pregnancy in the United States.

One out of every 10 women aged 15-19 becomes pregnant each year in the United States. Of these pregnancies, five out of every six are unintended--92 percent of those conceived premaritally, and half of those conceived in marriage. The teenage pregnancy rate is high because only a minority (one in three) of sexually active young women always use contraceptives, and only one in two of these women rely on the most effective methods. The two most common reasons given by adolescents for not using contraceptives are believing that the risk of pregnancy is small, and failing to anticipate intercourse. Experience in other developed countries clearly shows that the incidence of adolescent pregnancy can be reduced if effective contraceptives are made widely available. Although high quality sex education programs that include information about contraception, reproductive biology and responsible sexual behavior can enhance the effectiveness of contraceptive delivery systems, they are not a substitute for the actual provision of services and supplies. However, there is formidable political opposition to the provision of such services by a vocal minority who believe that the crux of the problem is premarital sexual activity, and that lowering the cost of such behavior by reducing the risk of pregnancy will both legitimize adolescent sex and increase its prevalence. Consequently, there is a political impasse that guarantees a continuing large number of adolescent pregnancies. Further, even if contraceptives and sex education were readily available to all adolescents, there would still be a pool of teenagers who would see little benefit in postponing parenthood. This pool would be composed overwhelmingly of the poor and of blacks and Hispanics. Increasing the demand for pregnancy prevention among young women and men in this hard-core, high-risk group will be extremely hard to achieve without a fundamental restructuring of society.