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")

  1. Low to normal serum follicle-stimulating hormone (FSH) concentrations
  2. Low serum estradiol concentrations

WHO II

  1. Amenorrhea or oligomenorrhea (mean cycle >35 days during the last 6 months)
  2. Normal serum FSH concentrations (<12 IU/L)
  3. 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:

  1. Oligo-/anovulation
  2. Clinical and/ or biochemical hyperandrogenism
  3. Polycystic ovaries on ultrasonography

WHO III

  1. primary ovarian insufficiency (POI): defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L.
  2. 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