A Prospective Cohort Study to Evaluate the Impact of Diet, Exercise, and Lifestyle on Fertility (IDEAL): Design and Baseline Characteristics.

Diet, lifestyle, and psychosocial factors may influence fertility for men and women, though evidence is mixed, and couple-based approaches are needed for assessing associations with reproductive outcomes. The Impact of Diet, Exercise, and Lifestyle on Fertility (IDEAL) study is a prospective cohort with contemporaneous detailed follow-up of female partners of men enrolled in the Folic Acid and Zinc Supplementation Trial studying couples seeking infertility treatment (2016-2019). Follow-up of men continued for 6 months, while female partners were followed for 9 months while attempting pregnancy and throughout any resulting pregnancy (up to 18 months). Longitudinal data on diet, physical activity (including measurement via Fitbit), sleep, and stress were captured at multiple study visits during this follow-up. A subset of women (IDEALplus) also completed daily journals and a body fat assessment via dual X-ray absorptiometry. 920 women were enrolled in IDEAL and 218 in IDEALPlus. We demonstrated the ability to enroll women in a prospective cohort study contemporaneous to a partner-enrolled randomized trial. In combination with data collected on male partners, IDEAL data facilitates a couple-based approach to understanding associations between lifestyle factors and infertility treatment outcomes. We describe in detail the study design, recruitment, data collection, lessons learned, and baseline characteristics.

American journal of epidemiology. 2020 May 30 [Epub ahead of print]

Sunni L Mumford, Erica Johnstone, Keewan Kim, Mudsar Ahmad, Shanna Salmon, Karen Summers, Kayla Chaney, Ginny Ryan, James M Hotaling, Alexandra C Purdue-Smithe, Zhen Chen, Traci Clemons

Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, Utah., Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, Iowa City, Iowa., The Emmes Company LLC, Rockville, Maryland., Department of Surgery (Urology), Center for Reconstructive Urology and Men's Health, University of Utah School of Medicine, Salt Lake City, Utah., Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy ShriverNational Institute of Child Health and Human Development, Bethesda, Maryland.