NCT05358483

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
247mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2021Dec 2046

Study Start

First participant enrolled

September 7, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
24.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2046

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2046

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

25.2 years

First QC Date

December 15, 2021

Last Update Submit

June 14, 2026

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Live birth after embryo transfer

    Live birth after embryo transfer (y/n)

    ~0-24 months

Secondary Outcomes (97)

  • Cycle number

    ~0-24 months

  • AMH

    ~0-24 months

  • Antral follicle count (AFC)

    ~0-24 months

  • Diagnosis/reason for ART

    ~0-24 months

  • Stimulation type

    ~0-24 months

  • +92 more secondary outcomes

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine Fertility and Reproductive Medicine

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Officials

  • Emily Jungheim, MD, MCSI

    Division Chief of Reproductive Endocrinology and Infertility

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Jungheim, MD, MSCI

CONTACT

312-926-6643Emily.Jungheim@nm.org

Brianna Borger, BS

CONTACT

312-503-8208Brianna.Borger1@nm.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

December 15, 2021

First Posted

May 3, 2022

Study Start

September 7, 2021

Primary Completion (Estimated)

December 1, 2046

Study Completion (Estimated)

December 1, 2046

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations

US(1)