NCT03306849

Brief Summary

The investigators would like to determine whether ultrasound features of the ovaries can be used to reliably diagnose different types of anovulatory disorders in women across all body types. The study will also try to establish whether ultrasound features of the ovary can reflect the degree of reproductive and metabolic problems that a woman with irregular or absent periods might be experiencing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

7.7 years

First QC Date

October 6, 2017

Last Update Submit

February 8, 2024

Conditions

Menstrual Cycle AbnormalPCOSOverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Follicle number per ovary

    The number and size of all follicles in each ovary will be assessed by ultrasonography

    1 day

Secondary Outcomes (16)

  • Follicle number per cross section

    1 day

  • Ovarian volume

    1 day

  • Stromal echogenicity on ultrasound

    1 day

  • Ovarian area-stromal area ratio

    1 day

  • LH-FSH ratio

    1 day

  • +11 more secondary outcomes

Study Arms (3)

Regular menstrual cycles

Women will be assigned to this category if they report a history of regular menstrual cycles (every 21 to 35 days). Recruitment will be targeted such that equal numbers of lean (BMI \<25kg/m2) and overweight or obese (BMI \>24.9kg/m2) participate.

Normoandrogenic anovulation

Women will be assigned to this category if they do not have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (\<21 days or \>35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI \<25kg/m2) and overweight or obese (BMI \>24.9kg/m2) participate.

Hyperandrogenic anovulation

Women will be assigned to this category if they have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (\<21 days or \>35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted such that equal numbers of lean (BMI \<25kg/m2) and overweight or obese (BMI \>24.9kg/m2) participate.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women must be able to transport to Weill Cornell University. Eligible participants are between 18-45 years with a BMI of 18.5 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Women are recruited from the general population. Enrollment is restricted to the geographical area.

You may qualify if:

  • Aged 18-45 years
  • At least 2y post-menarche
  • BMI \>18.5kg/m2
  • Good visibility of the ovaries on ultrasound
  • Either:
  • Regular menstrual cycles (21-35 days);
  • Irregular menstrual cycles (\>35 days); or
  • Previous diagnosis of PCOS from a primary care provider

You may not qualify if:

  • Weight \>300lbs
  • Currently pregnant or breast feeding
  • History of ovarian surgery
  • Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months
  • Evidence of reproductive aging as assessed by the principal criteria of STRAW+10 stages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Science Center

New York, New York, 10065, United States

Location

Biospecimen

Retention: NONE RETAINED

26mL Blood

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marla E Lujan, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

  • Steven Spandorfer, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

August 1, 2015

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

US(1)