PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Infertility, Female. Basic parameters: 18 years — 44 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Overview
The goal of the PROMISE study is to determine how pre-conception lifestyle factors (e.g., sleep, nutrition, physical activity) affect short- and long-term reproductive outcomes.
Detailed description
The overall goal of the PROMISE study is to identify strategies to improve health outcomes for women and their children. The proposed study is important and novel as it aims to capture women before they are pregnant. Current research on maternal and child health often focuses on women who are already pregnant. This time period is likely too late to make a meaningful clinical impact on long term maternal and child health outcomes influenced by social and epidemiologic determinants of health as important epigenetic changes are or have already taken place. Examples of tools that will be used to capture social and epidemiologic data include validated surveys for nutrition, physical activity, sleep, and stress. The importance of these tools is that many of the data points captured are modifiable, and therefore if associations are noted between these data points and health outcomes, actionable interventions may be developed and implemented for women who are preconceptional.
Primary outcome measures
- Live birth after embryo transfer [Time frame: ~0-24 months]
Secondary outcome measures (12)
- Cycle number [Time frame: ~0-24 months]
- AMH [Time frame: ~0-24 months]
- Antral follicle count (AFC) [Time frame: ~0-24 months]
- Diagnosis/reason for ART [Time frame: ~0-24 months]
- Stimulation type [Time frame: ~0-24 months]
- Total gonadotropin dose (IU/L) [Time frame: ~0-24 months]
- Maximum estradiol level (pmol/L) [Time frame: ~0-24 months]
- Days of stimulation [Time frame: ~0-24 months]
- Trigger type [Time frame: ~0-24 months]
- Sperm source [Time frame: ~0-24 months]
- Number follicles >14 mm [Time frame: ~0-24 months]
- Cycle cancellation [Time frame: ~0-24 months]
Eligibility criteria
Inclusion criteria
- Women ages 18-44 seeking pregnancy at Northwestern Fertility and Reproductive Medicine (FRM) who agree to
- Be followed for a period for up to 25 years
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Northwestern Medicine Fertility and Reproductive Medicine — Chicago
Identifiers
NCT: NCT05358483 · STU00215252