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NCT Number: NCT05358483

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.

Recruiting

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Key information

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Northwestern Medicine Fertility and Reproductive Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Brianna Borger, BS

CONTACT

[email protected]

312-503-8208

Emily Jungheim, MD, MSCI

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Live birth after embryo transfer

    Time frame: ~0-24 months

    Live birth after embryo transfer (y/n)

Secondary outcomes

  1. Cycle number

    Time frame: ~0-24 months

    IVF cycle number

  2. AMH

    Time frame: ~0-24 months

    Most recent AMH

  3. Antral follicle count (AFC)

    Time frame: ~0-24 months

    Most recent AFC

  4. Diagnosis/reason for ART

    Time frame: ~0-24 months

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

  5. Stimulation type

    Time frame: ~0-24 months

    Antagonist, microcode flare, long agonist, minimal stimulation

  6. Total gonadotropin dose (IU/L)

    Time frame: ~0-24 months

    Total gonadotropin dose

  7. Maximum estradiol level (pmol/L)

    Time frame: ~0-24 months

    Maximum estradiol level

  8. Days of stimulation

    Time frame: ~0-24 months

    Total number of days of stimulation

  9. Trigger type

    Time frame: ~0-24 months

  10. Sperm source

    Time frame: ~0-24 months

  11. Number follicles >14 mm

    Time frame: ~0-24 months

  12. Cycle cancellation

    Time frame: ~0-24 months

    Cycle cancellation (Y/N). If Y, reason for cancellation

  13. Number of oocytes retrieved

    Time frame: ~0-24 months

  14. Number of mature oocytes

    Time frame: ~0-24 months

  15. Number of blastocysts

    Time frame: ~0-24 months

  16. Number of embryos transferred

    Time frame: ~0-24 months

  17. Day of embryo transfer

    Time frame: ~0-24 months

  18. Type of embryo transfer

    Time frame: ~0-24 months

    Frozen or fresh embryo transfer

  19. Frozen embryo transfer protocol

    Time frame: ~0-24 months

  20. Luteal phase support

    Time frame: ~0-24 months

  21. Number of embryos cryopreserved

    Time frame: ~0-24 months

  22. Stage of embryo cryopreservation

    Time frame: ~0-24 months

  23. Grade of embryo transferred

    Time frame: ~0-24 months

  24. PGT

    Time frame: ~0-24 months

  25. PGT indication

    Time frame: ~0-24 months

  26. PGT methodology

    Time frame: ~0-24 months

  27. Endometrial thickness

    Time frame: ~0-24 months

  28. Ovarian hyperstimulation syndrome

    Time frame: ~0-24 months

  29. Clinical outcome

    Time frame: ~0-24 months

  30. Insemination Type

    Time frame: ~0-24 months

    ICSI, conventional, split

  31. Singleton pregnancy

    Time frame: ~12-36 months

  32. Multiple gestation

    Time frame: ~12-36 months

  33. Asthma

    Time frame: ~12-36 months

  34. Gestational diabetes

    Time frame: ~12-36 months

  35. Insulin

    Time frame: ~12-36 months

  36. Gestational hypertension/pre-eclampsia

    Time frame: ~12-36 months

  37. Abruption

    Time frame: ~12-36 months

  38. Placental disorders

    Time frame: ~12-36 months

    Placenta accreta, Placenta previa, Placenta increta, Placenta percreta

  39. Intrauterine growth restriction

    Time frame: ~12-36 months

  40. Congenital malformation

    Time frame: ~12-36 months

    Cleft palate, genetic defect, limb defect, cardiac defect, other

  41. Thyroid disease

    Time frame: ~12-36 months

  42. Heart disease

    Time frame: ~12-36 months

  43. Renal disease

    Time frame: ~12-36 months

  44. Polyhydramnios

    Time frame: ~12-36 months

  45. Lupus

    Time frame: ~12-36 months

  46. Clinical chorioamnionitis

    Time frame: ~12-36 months

  47. Prenatal genetic testing

    Time frame: ~12-36 months

  48. Type of prenatal genetic testing

    Time frame: ~12-36 months

    NIPT, CVS, amniocentesis

  49. Maternal blood type

    Time frame: ~12-36 months

  50. Preconception COVID vaccination

    Time frame: ~12-36 months

  51. Pregnancy COVID vaccination

    Time frame: ~12-36 months

  52. Predelivery hospitalization

    Time frame: ~12-36 months

  53. Maternal weight at oocyte retrieval

    Time frame: ~12-36 months

    Weight (lbs)

  54. Maternal height at oocyte retrieval

    Time frame: ~12-36 months

    Height (inches)

  55. Number of mature oocytes inseminated

    Time frame: ~0-24 months

  56. Number of mature oocytes fertilized (2PN)

    Time frame: ~0-24 months

  57. Maternal weight at embryo transfer

    Time frame: ~12-36 months

  58. Maternal weight at last OB visit

    Time frame: ~12-36 months

  59. Maternal weight at 1 year postpartum

    Time frame: ~12-36 months

  60. Date of delivery

    Time frame: ~12-36 months

  61. Time of delivery

    Time frame: ~12-36 months

  62. Weight at delivery

    Time frame: ~12-36 months

  63. Mode of delivery

    Time frame: ~12-36 months

  64. Preterm birth

    Time frame: ~12-36 months

    Birth <37 weeks

  65. Spontaneous preterm birth

    Time frame: ~12-36 months

  66. Presentation of spontaneous preterm birth (if applicable)

    Time frame: ~12-36 months

  67. Tocolytic medication during pregnancy

    Time frame: ~12-36 months

  68. Gestational age at delivery

    Time frame: ~12-36 months

  69. Presentation of term birth (if applicable)

    Time frame: ~12-36 months

  70. Magnesium sulfate administered

    Time frame: ~12-36 months

  71. Intrapartum antibiotics

    Time frame: ~12-36 months

  72. Length of hospital stay

    Time frame: ~12-36 months

  73. Head circumference

    Time frame: ~12-36 months

  74. Maternal mortality

    Time frame: ~12-36 months

  75. Infection

    Time frame: ~12-36 months

  76. Anesthetic complication

    Time frame: ~12-36 months

  77. Antepartum hemorrhage

    Time frame: ~12-36 months

  78. Postpartum hemorrhage

    Time frame: ~12-36 months

  79. Blood transfusion

    Time frame: ~12-36 months

  80. Thromboembolism

    Time frame: ~12-36 months

  81. Birthweight

    Time frame: ~12-36 months

  82. Small-for-gestational age

    Time frame: ~12-36 months

  83. Large-for-gestational age

    Time frame: ~12-36 months

  84. 1-min APGAR score

    Time frame: ~12-36 months

  85. 5-min APGAR score

    Time frame: ~12-36 months

  86. Arterial umbilical cord pH

    Time frame: ~12-36 months

  87. Breastfeeding compliance

    Time frame: ~12-48 months

  88. Postpartum weight change

    Time frame: ~12-48 months

  89. General well-being

    Time frame: ~12-48 months

  90. Length of NICU stay

    Time frame: ~12-48 months

  91. Neonatal death

    Time frame: ~12-48 months

    <28 days post delivery

  92. Breastfeeding

    Time frame: ~12-48 months

  93. Supplemental formula

    Time frame: ~12-48 months

  94. Breastfeeding at 1 year of life

    Time frame: ~12-48 months

  95. Child weight at 1 year of life

    Time frame: ~12-48 months

  96. Child height at 1 year of life

    Time frame: ~12-48 months

  97. NICU admission

    Time frame: ~12-48 months

Study contacts

Contact information is provided by the study sponsor or research team.

Brianna Borger, BS

CONTACT

[email protected]

312-503-8208

Emily Jungheim, MD, MSCI

CONTACT

[email protected]

312-926-6643

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Acronym: PROMISE

Important dates

Study start
2021
Primary completion
2046
Study completion
2046
First posted
May 3, 2022
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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