PCOS Polycystic ovary syndrome
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
16 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Women with signs and symptoms of PCOS, including: irregular or absent menstrual cycle, hirsutism or polycystic ovarian morphology who undergoing a standardized screening (COLA screening) - Age range 16-45 years - Sufficient command of the Dutch language - Signed written informed consent
Exclusion criteria
Exclusion criteria: - Documented ongoing pregnancy - Malignancy (documented malignancy, documentation of current radiation therapy or chemotherapy in medical record) - If transvaginal ultrasound is not possible or it is inappropriate - Not willing to share clinical data with Roche and Evidencio - Use of hormonal medication in the past three months, including hormonal IUD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The validity of the PriskA tool to diagnose PCOS, by assessing the sensitivity and specificity of the risk probabilities of 0.2 and 0.8. Parameters that will be used: - Testosterone level in serum (using Elecsys using Cobas 6000) - SHBG level in serum (using Elecsys using Cobas 6000). - AMH level in serum (using Elecsys using Cobas 6000). - LH level in serum (using Elecsys using Cobas 6000) - FSH level in serum (using Elecsys using Cobas 6000) - Cycle information - Age - BMI | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary study parameter is to assess the number (percentage) and characteristics of patients with a PriskA score between 0.2-0.8. Characteristics will include: menstrual cycle information, age, BMI, serum LH, serum FSH, serum AMH, serum testosterone, serum SHBG, serum progesterone, serum estradiol, total follicle count, PCOS phenotype (if applicable), WHO diagnosis or other endocrinological diagnosis. Another secondary parameter is the user experience of the PriskA tool. This will be collected from every user by a questionnaire. Questionnaires will be collected from every user when he/she completed 20 patients during the study. | — |
Countries
Netherlands
Outcome results
None listed