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Assisted reproduction is increasingly available to infertile and sub-fertile people in the developed countries and in many developing countries (also referred to as "low resource settings"). Correspondingly, the sophisticated treatment regimens associated with assisted reproduction are being applied to an expanding population of otherwise healthy infertile people.

As a result, questions have been raised on the effectiveness, safety, availability and costs of these procedures, as well as the many ethical and legal aspects of their use. It is therefore understandable that the practice of assisted reproduction and its clinical outcomes have been reported extensively in the literature during the last decade. However, most of these reports have come from individual clinical centers and are based on relatively small numbers of patients. Therefore, the applicability of specific results and outcomes from such small and highly selected patients to the general populations seeking treatment is limited.

During its infancy, assisted reproduction was only available at a small number of specialized research institutions worldwide. Individual clinical experiences could be exchanged through the scientific literature, international conferences or informal communication among the well-known clinical centers. With the increase in both the number of clinics providing these techniques and the number of patients receiving treatment, more rigorous data collection has become necessary.

Data Collection Rationale

To understand better the scope and impact of assisted reproduction, public health agencies and medical societies worldwide have established or soon will establish national surveillance systems for these technologies.

The collection of data on the outcomes and possible adverse effects of assisted reproductive techniques can assist:

  1. Patients seeking medical assistance for their infertility by allowing them to make informed and appropriate decisions concerning their own treatment options.
  2. The Medical Profession and Laboratory Professionals in providing optimal patient care by advancing the research and development of more effective forms of treatment while documenting the effectiveness of currently available techniques.
  3. Public Health Authorities responsible for assuring public safety, developing health care delivery policies and ensuring cost reimbursement.
  4. The Public in understanding better the assisted reproductive technologies and their role and value in helping people with infertility and other medical problems.

The collection and pooling of data on assisted reproduction occur at different levels for different purposes:

  1. Individual centers – collect data for monitoring their own procedures, for research purposes within their own clinic, as a basis for information provided to their patients, and as a basis for publication of results.
  2. National and regional registries – are increasing in number since they enable countries to summarize the total experience of all identified clinics performing assisted reproductive technology treatment. Such registry programs avoid the difficulties in interpreting the results of a small number of clinics performing, for example, limited forms of assisted reproduction on relatively small numbers of patients. Furthermore, an individual clinic can compare its practice and treatment outcomes with others within its country.
  3. International data collection programs – have been conducted largely as multicenter epidemiologic studies rather than as multinational registry programs. International data collection and analysis for research studies primarily serves the purpose of identifying rare but very important events, where even national programs often are restricted.
  4. An international registry – is important to describe the worldwide use of ART according to availability, effectiveness, safety, and to identify similarities, differences and trends.

Data Collection Methodology

Data collection and data handling can be done following either of two strategies:

  1. The national collection and analysis of clinic result summaries – is a reasonably inexpensive and simple way to record a number of defined events such as the proportions of treatment cycles resulting in pregnancy, the proportion of miscarriages, the proportion of ectopic pregnancies etc. Each center then usually operates its own type of data collection and only gives a yearly summary report. The disadvantage of such a strategy is that it gives no opportunities to identify key factors influencing the outcomes within the system so only general trends in the previously defined events can be followed over time.
  2. The centralized collection of data from all individual treatment cycles started in all centers within one country – is a more difficult and expensive approach requiring a larger staff of professionals centrally for data handling. It also requires that the individual centers agree to use a uniform data system. The resulting registry has considerable advantages over the first, simple strategy described above since it will give opportunities for research on multiple factors influencing selected outcomes of interest.

The USA and Sweden initially adopted the first strategy, but switched over to the second strategy. The UK, Germany, France, Australia and New Zealand have followed the second strategy for the duration of their ART collection. It is obvious that the second strategy leads to a more sophisticated and serviceable database, but the additional cost must be considered.

Published data need to meet the demands of the ART professionals and the public. The information needs to be interpreted and presented with relevant professional comments to avoid misinterpretation. Publication of crude (unadjusted) pregnancy rates from individual centers alone cannot be the primary goal of an international registry. Indeed, such presentations may not be in the best interest of the public.

A major accomplishment of any international working group, therefore, should be to define standard definitions and methods for presenting information, thereby facilitating interpretation and inference. ICMART has done this most recently in cooperation with the World Health Organization (WHO). ICMART is a non-governmental organization (NGO) in official relations with WHO.

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