Clinical Trial: The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
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 Summary:
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.
Within women with WHO II status, polycystic ovary syndrome (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
- primary ovarian insufficiency (POI): defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L.
- incipient ovarian failure (IOF): defined as normal-ovula
Sponsor: UMC Utrecht
Current Primary Outcome:
- 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.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- autoimmunity in WHO 3- POI patients [ Time Frame: within 3 months ]antithyroid peroxidase, antiadrenal, antiparietal and antiovarian antibodies
- bone density in WHO 3- POI patients [ Time Frame: within 3 months ]a dual-energy x-ray absorptiometry (DEXA) scan
- genotype in WHO 3 POI patients [ Time Frame: within 3 months ]karotype, fragile X mental retardation 1 gene premutation carriership
Original Secondary Outcome: Same as current
Information By: UMC Utrecht
Dates:
Date Received: November 12, 2014
Date Started: October 2004
Date Completion: August 2020
Last Updated: May 15, 2017
Last Verified: May 2017
- hormonal classification [ Time Frame: within 6 weeks ]