The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- UMC Utrecht
- Enrollment
- 5,000
- Locations
- 1
- Primary Endpoint
- hormonal classification
Study Overview
Brief Summary
Through the COLA Study and Biobank the investigators hope to enable further identification of phenotype, endocrine, ethnic, and metabolic characteristics associated with menstrual cycle disturbances; and: the identification of genetic or other etiologic factors associated with cycle disturbances.
Detailed Description
Population Women with cycle disturbances are referred to the outpatient clinic specialized in cycle disturbances by 1st or 2nd line care providers for further diagnostic procedures.
Inclusion criteria WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")
- Low to normal serum follicle-stimulating hormone (FSH) concentrations
- Low serum estradiol concentrations
WHO II
- Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
- Normal serum FSH concentrations (<12 IU/L)
- Absence of other causes for the cycle disturbance, including: normal prolactin concentrations (<1.0 IU/L), normal thyroid stimulating hormone (TSH) concentrations (0.2 - 4.2 milli-International unit /L), abnormalities on ultrasonography.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")
- •Low to normal serum FSH concentrations
- •Low serum estradiol concentrations
- •Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
- •Normal serum FSH concentrations (<12 IU/L)
- •Absence of other causes for the cycle disturbance, including: normal prolactin concentrations (<1.0 IU/L), normal TSH concentrations (0.2 - 4.2 milliunits/L), abnormalities on ultrasonography.
- •Within women with WHO II status, PCOS is diagnosed when at least 2 of the following criteria are met:
- •Oligo-/anovulation
- •Clinical and/ or biochemical hyperandrogenism
- •Polycystic ovaries on ultrasonography
- •POI: defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L.
- •IOF: defined as normal ovulatory cycles with raised basal FSH > 12 IU/L before the age of 40 years.
- •TOF: defined as irregular cycles with raised basal FSH > 12 IU/L before the age of 40 years.
- •Poor ovarian response: defined as less than 4 oocytes retrieved or cancellation in case of absent follicle growth after ovarian hyperstimulation with 300 IU gonadotropins.
- •Early menopause: menopause occurring between age 40 and 45 years.
- •Hypergonadotropic primary amenorrhea: primary amenorrhea with raised basal FSH > 12 IU/L.
- •Exclusion criteria: Exclusion criteria
- •Age: younger than 18 yrs.
- •Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
hormonal classification
Time Frame: within 6 weeks
FSH, LH, Estradiol, Progesterone,Testosterone, Androstenedione, Sex hormone binding globulin (SHBG), Cortisol, TSH
metabolic profile
Time Frame: within 6 weeks
total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, insulin, glucose
ovarian reserve
Time Frame: within 6 weeks
anti mullerian hormone, FSH and antral follicle count.
Secondary Outcomes
- genotype in WHO 3 POI patients(within 3 months)
- autoimmunity in WHO 3- POI patients(within 3 months)
- bone density in WHO 3- POI patients(within 3 months)
Investigators
Bart CJM Fauser
professor BCJM Fauser
UMC Utrecht