PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health (PROMISE)

The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Emily Jungheim, MD, MSCI; Phone Number: 312-926-6643; Email: Emily.Jungheim@nm.org
• Study Contact Backup: Name: Jessica Almgren-Bell, BA; Phone Number: 312-694-6678; Email: Jessica.almgrenbell@nm.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Northwestern Medicine Fertility and Reproductive Medicine
      • Contact: Jessica Almgren-Bell, BA; Phone Number: 312-694-6678; Email: Jessica.almgrenbell@nm.org
      • Contact: Emily Jungheim, MD, MSCI; Email: Emily.Jungheim@nm.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The PROMISE Study is enrolling women undergoing IVF for the first time without use of a gestational carrier or donor oocytes.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth after embryo transfer	Live birth after embryo transfer (y/n)	~0-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycle number	IVF cycle number	~0-24 months
AMH	Most recent AMH	~0-24 months
Antral follicle count (AFC)	Most recent AFC	~0-24 months
Diagnosis/reason for ART	E.g., male factor, DOR, tubal factor	~0-24 months
Stimulation type	Antagonist, microcode flare, long agonist, minimal stimulation	~0-24 months
Total gonadotropin dose (IU/L)	Total gonadotropin dose	~0-24 months
Maximum estradiol level (pmol/L)	Maximum estradiol level	~0-24 months
Days of stimulation	Total number of days of stimulation	~0-24 months
Trigger type		~0-24 months
Sperm source		~0-24 months
Number follicles >14 mm		~0-24 months
Cycle cancellation	Cycle cancellation (Y/N). If Y, reason for cancellation	~0-24 months
Number of oocytes retrieved		~0-24 months
Number of mature oocytes		~0-24 months
Number of blastocysts		~0-24 months
Number of embryos transferred		~0-24 months
Day of embryo transfer		~0-24 months
Type of embryo transfer	Frozen or fresh embryo transfer	~0-24 months
Frozen embryo transfer protocol		~0-24 months
Luteal phase support		~0-24 months
Number of embryos cryopreserved		~0-24 months
Stage of embryo cryopreservation		~0-24 months
Grade of embryo transferred		~0-24 months
PGT		~0-24 months
PGT indication		~0-24 months
PGT methodology		~0-24 months
Endometrial thickness		~0-24 months
Ovarian hyperstimulation syndrome		~0-24 months
Clinical outcome		~0-24 months
Insemination Type	ICSI, conventional, split	~0-24 months
Singleton pregnancy		~12-36 months
Multiple gestation		~12-36 months
Asthma		~12-36 months
Gestational diabetes		~12-36 months
Insulin		~12-36 months
Gestational hypertension/pre-eclampsia		~12-36 months
Abruption		~12-36 months
Placental disorders	Placenta accreta, Placenta previa, Placenta increta, Placenta percreta	~12-36 months
Intrauterine growth restriction		~12-36 months
Congenital malformation	Cleft palate, genetic defect, limb defect, cardiac defect, other	~12-36 months
Thyroid disease		~12-36 months
Heart disease		~12-36 months
Renal disease		~12-36 months
Polyhydramnios		~12-36 months
Lupus		~12-36 months
Clinical chorioamnionitis		~12-36 months
Prenatal genetic testing		~12-36 months
Type of prenatal genetic testing	NIPT, CVS, amniocentesis	~12-36 months
Maternal blood type		~12-36 months
Preconception COVID vaccination		~12-36 months
Pregnancy COVID vaccination		~12-36 months
Predelivery hospitalization		~12-36 months
Maternal weight at oocyte retrieval	Weight (lbs)	~12-36 months
Maternal height at oocyte retrieval	Height (inches)	~12-36 months
Number of mature oocytes inseminated		~0-24 months
Number of mature oocytes fertilized (2PN)		~0-24 months
Maternal weight at embryo transfer		~12-36 months
Maternal weight at last OB visit		~12-36 months
Maternal weight at 1 year postpartum		~12-36 months
Date of delivery		~12-36 months
Time of delivery		~12-36 months
Weight at delivery		~12-36 months
Mode of delivery		~12-36 months
Preterm birth	Birth <37 weeks	~12-36 months
Spontaneous preterm birth		~12-36 months
Presentation of spontaneous preterm birth (if applicable)		~12-36 months
Tocolytic medication during pregnancy		~12-36 months
Gestational age at delivery		~12-36 months
Presentation of term birth (if applicable)		~12-36 months
Magnesium sulfate administered		~12-36 months
Intrapartum antibiotics		~12-36 months
Length of hospital stay		~12-36 months
Head circumference		~12-36 months
Maternal mortality		~12-36 months
Infection		~12-36 months
Anesthetic complication		~12-36 months
Antepartum hemorrhage		~12-36 months
Postpartum hemorrhage		~12-36 months
Blood transfusion		~12-36 months
Thromboembolism		~12-36 months
Birthweight		~12-36 months
Small-for-gestational age		~12-36 months
Large-for-gestational age		~12-36 months
1-min APGAR score		~12-36 months
5-min APGAR score		~12-36 months
Arterial umbilical cord pH		~12-36 months
Breastfeeding compliance		~12-48 months
Postpartum weight change		~12-48 months
General well-being		~12-48 months
Length of NICU stay		~12-48 months
Neonatal death	<28 days post delivery	~12-48 months
Breastfeeding		~12-48 months
Supplemental formula		~12-48 months
Breastfeeding at 1 year of life		~12-48 months
Child weight at 1 year of life		~12-48 months
Child height at 1 year of life		~12-48 months
NICU admission		~12-48 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Emily Jungheim, MD, MCSI, Division Chief of Reproductive Endocrinology and Infertility

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2021
• Primary Completion (Anticipated): December 1, 2046
• Study Completion (Anticipated): December 1, 2046

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 27, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: STU00215252

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No