NCT01927471

Brief Summary

The investigators would like to determine how aspects of metabolism and age influence ovarian function. The purpose of the study is to understand how nutrition and metabolism relate to follicle development in women with regular cycles, irregular cycles, or polycystic ovary syndrome (PCOS). We also plan to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

September 1, 2011

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

7.8 years

First QC Date

August 20, 2013

Last Update Submit

February 8, 2024

Conditions

Polycystic Ovary Syndrome (PCOS)Menstrual Irregularity

Keywords

Menstrual cyclesUltrasoundOvaryPolycystic Ovary Syndrome (PCOS)Physical activityDiet

Outcome Measures

Primary Outcomes (2)

  • Follicle number per ovary

    The number and size of all follicles in each ovary will be assess by ultrasonography for each participant with regular menstrual cycles, irregular menstrual cycles and PCOS.

    1 day

  • Insulin sensitivity

    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared across groups.

    1 day

Secondary Outcomes (14)

  • Ovarian Volume

    1 day

  • Anti-Müllerian hormone

    1 day

  • LH-FSH ratio

    1 day

  • Androgen concentrations

    1 day

  • Menstrual Cycle Length

    1 day

  • +9 more secondary outcomes

Study Arms (3)

Regular menstrual cycles

Adult women will be assigned to this category if they report a history of regular menstrual cycles. We will aim to recruit 120 women in this category.

Irregular menstrual cycles, no PCOS

Adult women will be assigned to this category if they report a history of irregular menstrual cycles, without a pre-existing diagnosis of PCOS. We will aim to recruit 120 women in this category.

Irregular menstrual cycles, with PCOS

Adult women will be assigned to this category if they report a history of irregular menstrual cycles with a pre-existing diagnosis of PCOS by a physician. We will aim to recruit 120 women in this category.

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women must be able to transport to Cornell University and University of Rochester. Eligible participants are between 18-48 years with a BMI of 18 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Enrollment is restricted to the geographical area.

You may qualify if:

  • Between 18 and 48 years
  • BMI ≥ 18 kg/m2
  • Either:
  • Regular menstrual cycles (21-35 days);
  • Irregular menstrual cycles (\>36 days); or
  • Previous diagnosis of PCOS from a primary care provider
  • If 21 years of age or older, must have had a healthy pelvic exam w/in the past 2 years

You may not qualify if:

  • Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity
  • Pregnant or breastfeeding
  • Not otherwise healthy
  • Significant weight changes within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Human Metabolic Research Unit, Cornell University

Ithaca, New York, 14853, United States

Location

Strong Fertility Center

Rochester, New York, 14623, United States

Location

CRC at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Biospecimen

Retention: NONE RETAINED

Blood serum, subcutaneous fat

MeSH Terms

Conditions

Polycystic Ovary SyndromeMenstruation DisturbancesMotor Activity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Marla E. Lujan, PhD

    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

August 20, 2013

First Posted

August 22, 2013

Study Start

September 1, 2011

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

US(3)