Clinical trial · Observational
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid19-related restrictions
Summary
Brief summary (as posted)
Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive age women, which causes disordered follicle growth and ovulation resulting in infertility. In addition women with PCOS have hyperandrogenemia and a dysregulated hormonal profile, resulting in altered feedback on the hypothalamic-pituitary-gonadal (HPG) axis. Obesity, insulin resistance, vitamin D (VD) deficiency and ageing worsen the symptoms. The gonadotrophins - follicle stimulating hormone (FSH) \& luteinising hormone (LH), along with the pregnancy hormone human chorionic gonadotrophin (hCG) have structural similarities. The altered levels of FSH and LH in women with PCOS cause production of hCG from the brain leading to false positive pregnancy tests. Part one of this project will involve the investigation of this over-production of hCG in urine and serum of women with PCOS to develop suitable ovulation and pregnancy test kits, in collaboration with Swiss Precision Diagnostics (SPD). In Part two of the project, we would like to see if intervention with VD supplementation and/or using myo-inositol supplement compared with metformin (insulin sensitiser), improves prediabetes, distribution of fat/water content, weight loss and menstrual cyclicity in women with PCOS. We aim to correlate these interventions with particular serum \& urine markers to develop better diagnostic tools.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose.
- timeFrame
- 6 months
- description
- Statistically significant differences in: levels of hormone/factors produced as measured in blood and urine samples sent to pathology lab; hormonal \& metabolic responses/parameters after dietary/pharmaceutical intervention
Secondary outcomes (1)
- measure
- Measurement of BMI
- timeFrame
- 6 months
- description
- BMI between different patient types
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women with PCOS (Rotterdam criteria) attending the endocrine clinic, aged between 18-45 years Exclusion Criteria: * There is a clear exclusion criteria under the Rotterdam criteria; age \<18 years or \>45 years; oral contraceptive use within 3 months prior to recruitment, diabetes mellitus \& pregnancy
References
Publications (0)
Data not yet available