Clinical trial · Observational
Nutritional and Metabolic Correlates of Ovarian Morphology in Women With Polycystic Ovary Syndrome
NCT01927471CI-TRIAL-00073862completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Menstrual Irregularity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Regular menstrual cycles
- description
- 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.
- label
- Irregular menstrual cycles, no PCOS
- description
- 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.
- label
- Irregular menstrual cycles, with PCOS
- description
- 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.
Primary outcomes (2)
- measure
- Follicle number per ovary
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 48 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDEvans AT, Rehani E, Smith B, Hong MD, Lewin Z, Hiroshige K, Spandorfer SD, Hajirasouliha I, Lujan ME, Hoeger KM. Diagnosis of Polycystic Ovary Syndrome With Predictive Modeling of Select Clinical Features. O G Open. 2026 Mar 19;3(2):e161. doi: 10.1097/og9.0000000000000161. eCollection 2026 Apr. PMID 41868592