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NCT04424576: OMG

Ovarian Morphology in Girls

Recruiting now Last updated 12 August 2024
What this trial tests

trial in Amenorrhea in 60 participants. Currently enrolling.

Timeline
31 January 2020
Primary endpoint
31 March 2025
31 March 2025

Quick facts

Lead sponsorCornell University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment60
Start date31 January 2020
Primary completion31 March 2025
Estimated completion31 March 2025
Sites3 locations across United States

Conditions studied

Sponsor

Cornell University

Who can join

Adults 9 to 17, female only, with Amenorrhea or Oligomenorrhea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Changes in the Bile Acid Pool and Timing of Female Puberty: Potential Novel Role of Hypothalamic TGR5.
    Vanden Brink H, Vandeputte D, Brito IL, Ronnekleiv OK, et al · · 2024 · cited 11× · PMID 39082696 · DOI 10.1210/endocr/bqae098

Verify or expand the search:

Other recruiting trials for Amenorrhea

Currently open trials in the same condition.

Other Cornell University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04424576.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing