Infertility is a major health problem in the U.S. It affects approximately 4 million reproductive age women, almost 60,000 of whom undergo assisted reproductive technology (ART) procedures each year. ART currently results in over 35,000 U.S. live births and more than 50,000 babies each year. Most of these babies are healthy. However, studies suggest that a greater than average number of ART babies have health problems. There may also be adverse health effects for women who have ART and other infertility treatments. We do not know the extent of these problems because studies that attempt to define the risks have had small numbers of study subjects or used inappropriate comparison groups. So far, studies have been unable to distinguish the effects of treatments from the effects of the infertility diagnoses. We thus have a very limited understanding of the health problems caused by treatment. The goal of this study is to develop a large, renewable pool of patient volunteers who will be available for future studies of infertility disease and treatment in order to improve research in this field. This project will create an Infertility Family Research Registry (IFRR) to recruit study subjects from all over the U.S. The IFRR will fill the need for recruitment of sufficient numbers of study subjects to adequately address the risks of infertility treatments. Registries of this type have been used successfully in other fields of medicine including pediatrics and cancer research. We will do this project in conjunction with the Society for Assisted Reproductive Technology (SART), a professional organization that represents the clinics and providers of over 90% of ART procedures in the U.S. We have support for database development through the BioInformatics department at Dartmouth Medical School.
Our aims are to 1) implement strategies for nationwide passive recruitment of volunteers willing to be contacted as study subjects, 2) develop a database to hold information on volunteers and to track their involvement in studies, 3) manage post-recruitment validation of patient information while maintaining interest of volunteers and prospective investigators. Patients will self-identify to be part of the registry. They will enroll via the internet. We will encourage participation with advertisements and newsletters. We will encourage and support the use of the registry by researchers. Our goal is to provide a source of study subjects for research studies on ART and infertility. The long term goal is to facilitate high quality infertility research that uses adequate numbers of patients and appropriate comparison groups. We expect this registry to markedly improve the options for research in this population.
Infertility is a major U.S. health problem. Large numbers of study subjects are needed to adequately study the health effects of this disease and its treatments including assisted reproductive technology (ART). This project will recruit volunteers from across the country to a research registry that will help improve research on infertility.
