Study Objective
To evaluate the impact of dietary and other modifiable lifestyle factors in female partners on prospectively measured pregnancy outcomes among couples seeking fertility treatment (female partners of FAZST participants) in the context of a couple-based approach across a spectrum of fertility and treatment.
Background
Infertility affects approximately 16% of couples in the United States. Roughly one third of infertility is caused by male disorders, one third by female disorders, and one third by combined male and female disorders (per the CDC). The couple-based definition of infertility, combined with possible individual-level reproductive disorders, highlights the importance of including both partners in any study assessing modifiable factors and reproductive success.
While urological and/or gynecological disorders are the primary underlying causes for infertility, diet and other modifiable lifestyle and psychosocial factors in both men and women can potentially mitigate or exacerbate fertility problems. Effects of lifestyle and psychosocial factors (here meant to describe dietary and supplement intake, physical activity, stress, depression, anxiety, weight, sleep patterns, smoking, alcohol, caffeine consumption, sexual activity, and intimate partner violence) on ovulation, conception, implantation, and embryonic and fetal development remain largely unexplored, but offer the potential for low-cost strategies to improve fertility. Well-conducted prospective studies are scarce in regards to how a couple's peri-conceptional and, for women, early pregnancy dietary intake affect fertility. Thus, it is currently unclear how diet, exercise, stress, and other modifiable lifestyle factors impact reproductive outcomes both spontaneously and subsequent to the utilization of assisted reproductive technology (ART).
Study Design & Progress
IDEAL participants will complete the same activities as female partners in FAZST (a baseline visit with a questionnaire and biospecimen collection, monthly questionnaires updating their pregnancy and fertility treatment status, and follow-up for pregnancy outcomes via medical record abstraction). The IDEAL study expands this follow-up to include additional biospecimen collection, as well as a fitness tracker to wear throughout the study follow-up. These women will also have scheduled follow-up questionnaires at two points during their fertility treatment, as well as at-home biospecimen collection. If they become pregnant during the follow-up period (up to 9 months post-randomization), they will have three additional pregnancy follow-up clinic visits. Data regarding diet, exercise, and lifestyle will be collected throughout the follow-up period. Recruitment was completed in December 2017, with follow-up continuing in 2018.
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