Clinical trial NCT05358483: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Official title: The PROMISE Study: PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility, Female
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Live birth after embryo transfer
timeFrame: ~0-24 months
Secondary outcomes:
measure: Cycle number
timeFrame: ~0-24 months
measure: AMH
timeFrame: ~0-24 months
measure: Antral follicle count (AFC)
timeFrame: ~0-24 months
measure: Diagnosis/reason for ART
timeFrame: ~0-24 months
measure: Stimulation type
timeFrame: ~0-24 months
measure: Total gonadotropin dose (IU/L)
timeFrame: ~0-24 months
measure: Maximum estradiol level (pmol/L)
timeFrame: ~0-24 months
measure: Days of stimulation
timeFrame: ~0-24 months
measure: Trigger type
timeFrame: ~0-24 months
measure: Sperm source
timeFrame: ~0-24 months
measure: Number follicles >14 mm
timeFrame: ~0-24 months
measure: Cycle cancellation
timeFrame: ~0-24 months
measure: Number of oocytes retrieved
timeFrame: ~0-24 months
measure: Number of mature oocytes
timeFrame: ~0-24 months
measure: Number of blastocysts
timeFrame: ~0-24 months
measure: Number of embryos transferred
timeFrame: ~0-24 months
measure: Day of embryo transfer
timeFrame: ~0-24 months
measure: Type of embryo transfer
timeFrame: ~0-24 months
measure: Frozen embryo transfer protocol
timeFrame: ~0-24 months
measure: Luteal phase support
timeFrame: ~0-24 months
measure: Number of embryos cryopreserved
timeFrame: ~0-24 months
measure: Stage of embryo cryopreservation
timeFrame: ~0-24 months
measure: Grade of embryo transferred
timeFrame: ~0-24 months
measure: PGT
timeFrame: ~0-24 months
measure: PGT indication
timeFrame: ~0-24 months
measure: PGT methodology
timeFrame: ~0-24 months
measure: Endometrial thickness
timeFrame: ~0-24 months
measure: Ovarian hyperstimulation syndrome
timeFrame: ~0-24 months
measure: Clinical outcome
timeFrame: ~0-24 months
measure: Insemination Type
timeFrame: ~0-24 months
measure: Singleton pregnancy
timeFrame: ~12-36 months
measure: Multiple gestation
timeFrame: ~12-36 months
measure: Asthma
timeFrame: ~12-36 months
measure: Gestational diabetes
timeFrame: ~12-36 months
measure: Insulin
timeFrame: ~12-36 months
measure: Gestational hypertension/pre-eclampsia
timeFrame: ~12-36 months
measure: Abruption
timeFrame: ~12-36 months
measure: Placental disorders
timeFrame: ~12-36 months
measure: Intrauterine growth restriction
timeFrame: ~12-36 months
measure: Congenital malformation
timeFrame: ~12-36 months
measure: Thyroid disease
timeFrame: ~12-36 months
measure: Heart disease
timeFrame: ~12-36 months
measure: Renal disease
timeFrame: ~12-36 months
measure: Polyhydramnios
timeFrame: ~12-36 months
measure: Lupus
timeFrame: ~12-36 months
measure: Clinical chorioamnionitis
timeFrame: ~12-36 months
measure: Prenatal genetic testing
timeFrame: ~12-36 months
measure: Type of prenatal genetic testing
timeFrame: ~12-36 months
measure: Maternal blood type
timeFrame: ~12-36 months
measure: Preconception COVID vaccination
timeFrame: ~12-36 months
measure: Pregnancy COVID vaccination
timeFrame: ~12-36 months
measure: Predelivery hospitalization
timeFrame: ~12-36 months
measure: Maternal weight at oocyte retrieval
timeFrame: ~12-36 months
measure: Maternal height at oocyte retrieval
timeFrame: ~12-36 months
measure: Number of mature oocytes inseminated
timeFrame: ~0-24 months
measure: Number of mature oocytes fertilized (2PN)
timeFrame: ~0-24 months
measure: Maternal weight at embryo transfer
timeFrame: ~12-36 months
measure: Maternal weight at last OB visit
timeFrame: ~12-36 months
measure: Maternal weight at 1 year postpartum
timeFrame: ~12-36 months
measure: Date of delivery
timeFrame: ~12-36 months
measure: Time of delivery
timeFrame: ~12-36 months
measure: Weight at delivery
timeFrame: ~12-36 months
measure: Mode of delivery
timeFrame: ~12-36 months
measure: Preterm birth
timeFrame: ~12-36 months
measure: Spontaneous preterm birth
timeFrame: ~12-36 months
measure: Presentation of spontaneous preterm birth (if applicable)
timeFrame: ~12-36 months
measure: Tocolytic medication during pregnancy
timeFrame: ~12-36 months
measure: Gestational age at delivery
timeFrame: ~12-36 months
measure: Presentation of term birth (if applicable)
timeFrame: ~12-36 months
measure: Magnesium sulfate administered
timeFrame: ~12-36 months
measure: Intrapartum antibiotics
timeFrame: ~12-36 months
measure: Length of hospital stay
timeFrame: ~12-36 months
measure: Head circumference
timeFrame: ~12-36 months
measure: Maternal mortality
timeFrame: ~12-36 months
measure: Infection
timeFrame: ~12-36 months
measure: Anesthetic complication
timeFrame: ~12-36 months
measure: Antepartum hemorrhage
timeFrame: ~12-36 months
measure: Postpartum hemorrhage
timeFrame: ~12-36 months
measure: Blood transfusion
timeFrame: ~12-36 months
measure: Thromboembolism
timeFrame: ~12-36 months
measure: Birthweight
timeFrame: ~12-36 months
measure: Small-for-gestational age
timeFrame: ~12-36 months
measure: Large-for-gestational age
timeFrame: ~12-36 months
measure: 1-min APGAR score
timeFrame: ~12-36 months
measure: 5-min APGAR score
timeFrame: ~12-36 months
measure: Arterial umbilical cord pH
timeFrame: ~12-36 months
measure: Breastfeeding compliance
timeFrame: ~12-48 months
measure: Postpartum weight change
timeFrame: ~12-48 months
measure: General well-being
timeFrame: ~12-48 months
measure: Length of NICU stay
timeFrame: ~12-48 months
measure: Neonatal death
timeFrame: ~12-48 months
measure: Breastfeeding
timeFrame: ~12-48 months
measure: Supplemental formula
timeFrame: ~12-48 months
measure: Breastfeeding at 1 year of life
timeFrame: ~12-48 months
measure: Child weight at 1 year of life
timeFrame: ~12-48 months
measure: Child height at 1 year of life
timeFrame: ~12-48 months
measure: NICU admission
timeFrame: ~12-48 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine Fertility and Reproductive Medicine
state: Illinois
Study officials:
affiliation: Division Chief of Reproductive Endocrinology and Infertility
name: Emily Jungheim, MD, MCSI
role: PRINCIPAL_INVESTIGATOR
References: