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Infertility, FemalePROMISENCT05358483

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

An observational study of Infertility, Female, run by Northwestern University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 44 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female
How many people
1,000 participants
Where
1 siteUnited States
Study dates
7 Sep 2021to Dec 2046
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 44 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • Women using donor oocytes or gestational carriers
  • Inability or unwillingness to provide informed consent for any aspects of the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily Jungheim, MD, MSCI contact

312-926-6643

Emily.Jungheim@nm.org

Brianna Borger, BS contact

312-503-8208

Brianna.Borger1@nm.org

United States1 site, 1 recruiting

  • Northwestern Medicine Fertility and Reproductive Medicine

    Chicago, Illinois, 60611

    Emily Jungheim, MD, MSCI, Emily.Jungheim@nm.org

    Brianna Borger, BS, 312-503-8208, Brianna.Borger1@nm.org

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Medical subject headings
Infertility, Female

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth after embryo transfer

    Live birth after embryo transfer (y/n)

    Measured: ~0-24 months

Secondary outcomes (97)

  1. Cycle number

    IVF cycle number

    Measured: ~0-24 months

  2. AMH

    Most recent AMH

    Measured: ~0-24 months

  3. Antral follicle count (AFC)

    Most recent AFC

    Measured: ~0-24 months

  4. Diagnosis/reason for ART

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

    Measured: ~0-24 months

  5. Stimulation type

    Antagonist, microcode flare, long agonist, minimal stimulation

    Measured: ~0-24 months

  6. Total gonadotropin dose (IU/L)

    Total gonadotropin dose

    Measured: ~0-24 months

  7. Maximum estradiol level (pmol/L)

    Maximum estradiol level

    Measured: ~0-24 months

  8. Days of stimulation

    Total number of days of stimulation

    Measured: ~0-24 months

  9. Trigger type

    Measured: ~0-24 months

  10. Sperm source

    Measured: ~0-24 months

  11. Number follicles >14 mm

    Measured: ~0-24 months

  12. Cycle cancellation

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

    Measured: ~0-24 months

  13. Number of oocytes retrieved

    Measured: ~0-24 months

  14. Number of mature oocytes

    Measured: ~0-24 months

  15. Number of blastocysts

    Measured: ~0-24 months

  16. Number of embryos transferred

    Measured: ~0-24 months

  17. Day of embryo transfer

    Measured: ~0-24 months

  18. Type of embryo transfer

    Frozen or fresh embryo transfer

    Measured: ~0-24 months

  19. Frozen embryo transfer protocol

    Measured: ~0-24 months

  20. Luteal phase support

    Measured: ~0-24 months

  21. Number of embryos cryopreserved

    Measured: ~0-24 months

  22. Stage of embryo cryopreservation

    Measured: ~0-24 months

  23. Grade of embryo transferred

    Measured: ~0-24 months

  24. PGT

    Measured: ~0-24 months

  25. PGT indication

    Measured: ~0-24 months

  26. PGT methodology

    Measured: ~0-24 months

  27. Endometrial thickness

    Measured: ~0-24 months

  28. Ovarian hyperstimulation syndrome

    Measured: ~0-24 months

  29. Clinical outcome

    Measured: ~0-24 months

  30. Insemination Type

    ICSI, conventional, split

    Measured: ~0-24 months

  31. Singleton pregnancy

    Measured: ~12-36 months

  32. Multiple gestation

    Measured: ~12-36 months

  33. Asthma

    Measured: ~12-36 months

  34. Gestational diabetes

    Measured: ~12-36 months

  35. Insulin

    Measured: ~12-36 months

  36. Gestational hypertension/pre-eclampsia

    Measured: ~12-36 months

  37. Abruption

    Measured: ~12-36 months

  38. Placental disorders

    Placenta accreta, Placenta previa, Placenta increta, Placenta percreta

    Measured: ~12-36 months

  39. Intrauterine growth restriction

    Measured: ~12-36 months

  40. Congenital malformation

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

    Measured: ~12-36 months

  41. Thyroid disease

    Measured: ~12-36 months

  42. Heart disease

    Measured: ~12-36 months

  43. Renal disease

    Measured: ~12-36 months

  44. Polyhydramnios

    Measured: ~12-36 months

  45. Lupus

    Measured: ~12-36 months

  46. Clinical chorioamnionitis

    Measured: ~12-36 months

  47. Prenatal genetic testing

    Measured: ~12-36 months

  48. Type of prenatal genetic testing

    NIPT, CVS, amniocentesis

    Measured: ~12-36 months

  49. Maternal blood type

    Measured: ~12-36 months

  50. Preconception COVID vaccination

    Measured: ~12-36 months

  51. Pregnancy COVID vaccination

    Measured: ~12-36 months

  52. Predelivery hospitalization

    Measured: ~12-36 months

  53. Maternal weight at oocyte retrieval

    Weight (lbs)

    Measured: ~12-36 months

  54. Maternal height at oocyte retrieval

    Height (inches)

    Measured: ~12-36 months

  55. Number of mature oocytes inseminated

    Measured: ~0-24 months

  56. Number of mature oocytes fertilized (2PN)

    Measured: ~0-24 months

  57. Maternal weight at embryo transfer

    Measured: ~12-36 months

  58. Maternal weight at last OB visit

    Measured: ~12-36 months

  59. Maternal weight at 1 year postpartum

    Measured: ~12-36 months

  60. Date of delivery

    Measured: ~12-36 months

  61. Time of delivery

    Measured: ~12-36 months

  62. Weight at delivery

    Measured: ~12-36 months

  63. Mode of delivery

    Measured: ~12-36 months

  64. Preterm birth

    Birth <37 weeks

    Measured: ~12-36 months

  65. Spontaneous preterm birth

    Measured: ~12-36 months

  66. Presentation of spontaneous preterm birth (if applicable)

    Measured: ~12-36 months

  67. Tocolytic medication during pregnancy

    Measured: ~12-36 months

  68. Gestational age at delivery

    Measured: ~12-36 months

  69. Presentation of term birth (if applicable)

    Measured: ~12-36 months

  70. Magnesium sulfate administered

    Measured: ~12-36 months

  71. Intrapartum antibiotics

    Measured: ~12-36 months

  72. Length of hospital stay

    Measured: ~12-36 months

  73. Head circumference

    Measured: ~12-36 months

  74. Maternal mortality

    Measured: ~12-36 months

  75. Infection

    Measured: ~12-36 months

  76. Anesthetic complication

    Measured: ~12-36 months

  77. Antepartum hemorrhage

    Measured: ~12-36 months

  78. Postpartum hemorrhage

    Measured: ~12-36 months

  79. Blood transfusion

    Measured: ~12-36 months

  80. Thromboembolism

    Measured: ~12-36 months

  81. Birthweight

    Measured: ~12-36 months

  82. Small-for-gestational age

    Measured: ~12-36 months

  83. Large-for-gestational age

    Measured: ~12-36 months

  84. 1-min APGAR score

    Measured: ~12-36 months

  85. 5-min APGAR score

    Measured: ~12-36 months

  86. Arterial umbilical cord pH

    Measured: ~12-36 months

  87. Breastfeeding compliance

    Measured: ~12-48 months

  88. Postpartum weight change

    Measured: ~12-48 months

  89. General well-being

    Measured: ~12-48 months

  90. Length of NICU stay

    Measured: ~12-48 months

  91. Neonatal death

    <28 days post delivery

    Measured: ~12-48 months

  92. Breastfeeding

    Measured: ~12-48 months

  93. Supplemental formula

    Measured: ~12-48 months

  94. Breastfeeding at 1 year of life

    Measured: ~12-48 months

  95. Child weight at 1 year of life

    Measured: ~12-48 months

  96. Child height at 1 year of life

    Measured: ~12-48 months

  97. NICU admission

    Measured: ~12-48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start7 Sep 2021
  3. Primary completionDec 2046 (estimated)
  4. Study completionDec 2046 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358483
Sponsor's protocol ID
STU00215252
Acronym
PROMISE
Status last verified
Jun 2026
First submitted
15 Dec 2021
Last updated
16 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility, Female, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily Jungheim, MD, MSCI (312-926-6643, Emily.Jungheim@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth after embryo transfer (time frame: ~0-24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05358483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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