NCT01859663

Brief Summary

The purpose of the study is to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS. The secondary aim is to examine psychosocial factors (e.g., health beliefs) of women with PCOS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

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

May 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

9 years

First QC Date

May 17, 2013

Last Update Submit

February 8, 2024

Conditions

Polycystic Ovary SyndromeDietary HabitsPhysical Activity

Keywords

Polycystic Ovary Syndrome (PCOS)DietExerciseQuestionnairesHealth Beliefs

Outcome Measures

Primary Outcomes (1)

  • Differences in diet between women with and without PCOS

    A food frequency questionnaire will be administered to assess diet composition for the last three months.

    1 week

Secondary Outcomes (16)

  • Differences in exercise between women with and without PCOS

    1 week

  • Differences in psychosocial factors (e.g., health beliefs) of women with and without PCOS

    1-2 weeks

  • Differences in sleep patterns between women with and without PCOS

    6 consecutive nights

  • LH-FSH ratio

    1 day

  • Hirsutism Score

    1 day

  • +11 more secondary outcomes

Study Arms (3)

Women with a past diagnosis of PCOS

We aim to recruit 120 women with a past diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

Women with a history of regular menstrual cycles

We aim to recruit 120 women with a history of regular menstrual cycles. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

Women with a history of irregular menstrual cycles

We aim to recruit 120 women with a history of irregular menstrual cycles, and no previous diagnosis of PCOS. An equal number of lean and overweight/obese women will be recruited within this group based on body mass index (BMI; Lean = 18 - 24 kg/m2 and overweight/obese ≥ 25 kg/m2).

Eligibility Criteria

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

New York State. Must be between 18-48 years, with a BMI of 18 kg/m2 or higher.

You may qualify if:

  • Between 18 and 48 years
  • BMI ≥ 18 kg/m2
  • If ≥ 21 years old, must have completed a pelvic exam in the past 2 years
  • In PCOS if: Confirmed PCOS diagnosis from their primary care provider

You may not qualify if:

  • Use of oral contraceptives, fertility medications, or any drugs known to influence reproductive function
  • Pregnant or breastfeeding

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

Related Publications (1)

  • Lin AW, Dollahite JS, Sobal J, Lujan ME. Health-related knowledge, beliefs and self-efficacy in women with polycystic ovary syndrome. Hum Reprod. 2018 Jan 1;33(1):91-100. doi: 10.1093/humrep/dex351.

    PMID: 29182737DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and urine samples. Subcutaneous fat biopsy.

MeSH Terms

Conditions

Polycystic Ovary SyndromeFeeding BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesBehavior, AnimalBehavior

Study Officials

  • Marla E. Lujan, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 17, 2013

First Posted

May 22, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations

US(3)