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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Female

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 |