Study on how lifestyle factors affect women's reproductive health before pregnancy
The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
This study looks at how things like sleep, diet, and exercise can affect women's health and pregnancy outcomes before they become pregnant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 44 Years |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05358483 on ClinicalTrials.gov |
What this trial studies
The PROMISE study aims to explore the impact of pre-conception lifestyle factors such as sleep, nutrition, and physical activity on reproductive outcomes for women and their children. By focusing on women aged 18-44 who are seeking pregnancy, the study seeks to gather data on social and epidemiologic determinants of health before conception. This observational study will utilize validated surveys to collect information on modifiable lifestyle factors, with the goal of identifying actionable interventions that could improve long-term health outcomes. The study will follow participants for up to 25 years, allowing for a comprehensive analysis of health trends over time.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-44 who are actively seeking pregnancy and have not undergone prior IVF cycles.
Not a fit: Patients using donor oocytes or gestational carriers, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved reproductive health outcomes for women and their children by identifying effective pre-conception interventions.
How similar studies have performed: While there is existing research on maternal and child health, this study's focus on pre-conception factors is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to 1. Be followed for a period for up to 25 years 2. Share information regarding their child's health * No prior IVF cycles Exclusion Criteria: * Women using donor oocytes or gestational carriers * Inability or unwillingness to provide informed consent for any aspects of the study
Where this trial is running
Chicago, Illinois
- Northwestern Medicine Fertility and Reproductive Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Emily Jungheim, MD, MCSI — Division Chief of Reproductive Endocrinology and Infertility
- Study coordinator: Emily Jungheim, MD, MSCI
- Email: Emily.Jungheim@nm.org
- Phone: 312-926-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.