Status:
UNKNOWN
The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Lead Sponsor:
UMC Utrecht
Conditions:
Anovulation
Eligibility:
FEMALE
18-45 years
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; ...
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 criteri...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")
- Low to normal serum 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 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
- WHO III
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT02309047
Start Date
October 1 2004
End Date
August 1 2023
Last Update
October 20 2021
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA