PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

Northwestern University1,000 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Infertility, Female

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 44 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Medicine Fertility and Reproductive Medicine

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

Live birth after embryo transfer

Live birth after embryo transfer (y/n)

Time frame: ~0-24 months

Secondary Outcomes

Cycle number

IVF cycle number

Time frame: ~0-24 months

AMH

Most recent AMH

Time frame: ~0-24 months

Antral follicle count (AFC)

Most recent AFC

Time frame: ~0-24 months

Diagnosis/reason for ART

E.g., male factor, DOR, tubal factor

Time frame: ~0-24 months

Stimulation type

Antagonist, microcode flare, long agonist, minimal stimulation

Time frame: ~0-24 months

Total gonadotropin dose (IU/L)

Total gonadotropin dose

Time frame: ~0-24 months

Maximum estradiol level (pmol/L)

Maximum estradiol level

Time frame: ~0-24 months

Days of stimulation

Total number of days of stimulation

Time frame: ~0-24 months

Trigger type

Time frame: ~0-24 months

Central Contacts

Emily Jungheim, MD, MSCI

CONTACT

312-926-6643 Emily.Jungheim@nm.org

Brianna Borger, BS

CONTACT

312-503-8208 Brianna.Borger1@nm.org

Data from ClinicalTrials.gov

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