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IUI is often the first intervention offered for unexplained or mild to moderate male infertility and appears to be a safe method to prevent HIV transmission. Pregnancy and delivery rates per cycle remained stable for years. Factors influencing IUI results and studies evaluating if first line IVF rather than IUI could be a better option for couples with unexplained or mild male infertility will be discussed.
Increased risks compared to spontaneous conceptions have been described. However, data on comparison with IVF is limited and points to similar or lower perinatal risks. Multiple pregnancies are responsible for most of perinatal morbidities and are dependent on the use and aggressiveness of ovarian stimulation. Cost efficiency appears to be influenced by the indication, associated medications and perinatal complications mainly related to multiple pregnancies. While currently IUI with ovarian stimulation seems cost-effective, further studies are needed to confirm it in settings with advanced ART techniques.
Australia established the first national ART registries in the world in 1983, collating treatment and outcome data on the just over 200 pregnancies achieved in Australia from IVF. New Zealand clinics soon followed, contributing data to the registry in 1984. The registry, now known as the Australian and New Zealand Assisted Reproductive Technology Database (ANZARD), is an example of successful cooperation and collaboration between clinicians, fertility clinics, universities and regulators. Under a fertility clinic’s licensing agreement all ART treatment cycles are required to be report to ANZARD, ensuring complete ascertainment is achieved. The data from the registry have been publicly reported without interruption on an annual basis by the National Perinatal Epidemiology and Statistics Unit (NPESU), formally the NPESU for over 30 years, and made widely available to consumers, policy makers and researchers. The ANZARD annual report includes over 80 descriptive tables including age-specific success rates from successive treatment cycles. One of ANZARD’s important achievements has been in supporting the fertility sector in Australia and New Zealand to reduce the multiple birth rate to become one of the lowest in the world, with rates consistently below 5%. ANZARD continues to evolve towards more automated data collection and reporting platforms, and periodic changes to the data dictionary to accommodate changing patient demographics, and scientific and clinical practice.
The increasing complexity and variation in ART laboratory and clinical practice, together with a recognition of the importance of patient-centered outcomes, makes ART registries a central resource for informing patients, regulators and governments about the performance of ART treatment. The sequential nature of ART treatment gives rise to a multitude of possible numerators and denominators for measuring treatment outcomes. Which combination of these is the most appropriate and important depends on the stakeholder perspective and the purpose of the measure. ART registries are used in a number of countries to measure ART performance, particularly for reporting at a fertility clinic level. While health data transparency generally leads to better decision making, the process of measurement itself has the potential to both positively and negatively alter the behavior of clinics and clinicians. Finally, personalized patient predictor tools developed using large registry datasets are becoming common and are likely to become an important tool to assist clinicians in counselling patients about their individual chances of ART success.
Safety of medical treatments implies all their side and long-term effects on patients. With reference to ART, subjects involved are mothers and their children.
Since the early application of IVF, operators have agreed on the importance of monitoring these new techniques in order to build and maintain trust towards them.
Collecting data regarding assisted reproduction techniques worldwide is of the utmost usefulness to ensure safety and quality of treatments provided, to detect potential problems, as well as to implement practices aimed at reducing risks and improving outcomes.
Nowadays, well-functioning registries have been set up in most countries. Regulations and guidelines for the monitoring of all clinical and laboratory aspects of assisted reproduction techniques have been issued, also based on data collected so far.
Currently available evidence should be the basis for a further improvement of medical and laboratory practices.
Infertility affects an estimated 80 million individuals worldwide, or 10–15% of couples of reproductive age. The number of assisted reproductive technology (ART) cycles in the United States more than doubled between 2000 and 2013. In 2015, about 1.7% of all live births in the United States were the result of this technology. In the US, studies of the long-term outcomes of ART involve the challenge of linking databases, in which one database has information on the treatment parameters, and the other database captures the outcomes of interest. This chapter discusses the linkage efforts, methodologies, and resulting research in the US by the Society for Assisted Reproductive Technology (SART) and the Centers for Disease Control and Prevention (CDC), and the health linkages routinely performed in the Nordic countries. Strengths and limitations of these approaches are also discussed.
Choosing ART treatment is a major life decision. Patients have a fundamental right to patient-centered healthcare that respects their unique needs, preferences and values.
At the heart of a patient’s question about success rates is the need to know whether they can be assured of the best chance of taking home a healthy baby.
However, choosing a clinic based solely on reported success rates can create unrealistic expectations, as pregnancy rates vary tremendously, depending on the type of treatment, the age and cause of infertility. ‘League Tables’ comparing the performance of one clinic to another can be misleading.
More than 25 years’ experience from patients’ organizations suggest that many pursue ART without fully understanding the risks and potential complications. The format of ART surveillance reports varies considerably and are usually written for a scientific audience.
Therefore, ART surveillance data should be available in a format that is unbiased, understandable and meaningful.
While many countries recognize the importance of collecting and using ART data, ART surveillance systems and other ART data collection tools, such as registries or repositories, vary according to ownership, reporting responsibility, type of data being reported, information being reported, data quality and validation activities, public reporting of success rates, reporting requirements, and data protection around the world. However, there is a need for ART surveillance systems to be simple, flexible, acceptable, representative, timely, and stable as well as to have high data quality, sensitivity, and positive predictive values. This chapter will explore each of these areas as they relate to ART surveillance.
ART was pioneered in Africa in the 1980’s. Subsequently, ART centres emerged around the continent, mostly by specialists acquiring skills abroad. Despite this, ART activity remains scant in most African countries and absent in several others.
Historically, ART surveillance in Africa has been similarly scant and fragmented. Recently however, the African Network and Registry for ART (ANARA) has been established with the vision to reduce the high burden of infertility in Africa through ART; and its mission to bring together ART centres within and across countries and to collect data pertaining to availability, utilization, effectiveness and safety of ART. First registry data, collected from 40 centres in 13 countries, and will be published shortly. ANARA protects the anonymity of centres and patients and the ownership of data.
The successful establishment of ANARA is rooted in a collaborative spirit of engagement with ART centres and other stakeholders, developmental assistance from both the Latin American and World Registry, and the importance of data in reducing the burden of infertility in Africa.
Asia is composed of more than 40 countries where about 60% of the global population live. Since Asia is the largest and geographically variable continent, where cultural and social backgrounds are very diverse in every part of this area, it is almost impossible to describe the whole area in one chapter. Rapid decline of birth rates in multiple countries, particularly in eastern Asia, drew wide public attention and promoted the treatment and care for infertile couples. Particularly, assisted reproductive technology (ART) has significantly spread in many Asian countries and its growth is still ongoing. Although ART registries were established in several Asian countries many years ago, there is no Asian regional registry because of this diverse situation of this area.
Nation-specific registries of ART treatments were established in the United States, Canada, and Mexico in 1985, 1999 and 1995 respectively. In the United States, reporting became mandatory in 1992, and 94% of nearly the 500 clinics report. In Canada, reporting is voluntary and all but one clinic is currently reporting. In Mexico, a small proportion (about 20%) of over 50 clinics report to their country’s registry. Initially these registries contained summaries of each clinic’s overall outcomes, but all have now become cycle-specific. While all registries have systems in place to ensure quality of data, prospective reporting and annual data validations are mandatory only in the United States. All registries have adjusted their online data collections systems to capture changes in clinical practice patterns. Clinic-specific ART reports are available online in all North American countries. Information from these registries has been valuable for research and to develop treatment guidelines; most significantly, guidelines regarding the number of embryos to transfer has led to a dramatic reduction in multiple pregnancy rates.
In many areas activities in assisted reproductive technology (ART) are being recorded and analyzed by registries, either on a voluntary or compulsory basis , and reports are generated producing cross-sectional data on an annual basis. Current ART is now developing towards a segmented longitudinal approach, in which single therapeutic steps are spread over prolonged time intervals, necessitating a cumulative approach in the handling of ART-data. This requires a unique identifier for each individual seeking fertility care together with an informed and signed consent. The identifier should reside with the institution offering fertility treatment and follow the infertile individual through the various therapeutic steps, even if leaving to another institution. The identifier should be added to all data submitted to the ART registry. This will allow the national health register to construct cumulative outcome data on all forms of fertility treatment, including long-term gamete and tissue freezing-related information.
The Latin American Registry of Assisted Reproduction (RLA) is part of the Latin American Network of Assisted Reproductive Technology (REDLARA). It is a voluntary registry, which collects and publishes regional data yearly since 1990. The main objective of RLA has been to disseminate information on ART procedures performed in Latin America. Since 2010, it is a cycle-based registry, used to monitor outcomes, as well as trends in safety and efficacy, contributing to the development of better health interventions in the region and the development of appropriate public policies. New centers willing to report to RLA are obliged to pass an accreditation processes, which is re-assessed every 5 years. The accreditation program started in 1985 and provides a certain guarantee for minimum standards of performing and reporting ART procedures but is also seen as an external quality control program that helps institutions look at their results and introduce changes when necessary.
Assisted reproductive technology (ART) surveillance data are important for assessing ART effectiveness and safety. Cycle-level and patient-level data allow the most detailed analysis. In using these data for research, it is important to recognize the strengths and limitations of surveillance data. The large sample size can facilitate precise estimation of the relationships between patient or treatment factors and outcomes, as well as permit detection of rare outcomes and trends over time. However, these databases may have limited detail compared with those designed specifically for research. Surveillance data allow the researcher to assess associations, but cannot prove causation. Appropriate strategies should be employed to address and communicate the limitations whenever possible. ART surveillance data should be available to interested and responsible researchers. Continued efforts to expand ART surveillance to additional countries will benefit the diverse population of women and men who are attempting to build their families using ART.
Although, IUI is one of the most frequently used fertility treatments worldwide insemination with and without ovarian stimulation and cycle-monitoring (timed intercourse) are only included in very few large national and international data collections on ART monitoring. . IUI is easy accessible, low tech, cheap and patient friendly and is efficient in the treatment of unexplained infertility and mild to moderate male factor infertility. Yet, another indication for IUI is in addition to ovulation induction in women with anovulatory infertility. The European IVF-Monitoring Consortium (EIM), an institution of the European Society of Human Reproduction and Embryology (ESHRE) has collected data on IUI since 1997.
This chapter comprises a definition of MAR and an overview of the worldwide current MAR monitoring. Moreover, we discuss the importance of including MAR and IUI in the ART monitoring programs to assess the full quality and safety of fertility treatments.