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The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank (COLA)

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ClinicalTrials.gov Identifier: NCT02309047
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Bart CJM Fauser, UMC Utrecht

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.

Condition or disease
Anovulation

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Cycle Disturbances, OLigomenorrhea and Amenorrhea (COLA) Study & Biobank
Actual Study Start Date : October 2004
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : August 2023

Group/Cohort
WHO anovulation
WHO I, II. III anovulation. See inclusion criteria



Primary Outcome Measures :
  1. hormonal classification [ Time Frame: within 6 weeks ]
    FSH, LH, Estradiol, Progesterone,Testosterone, Androstenedione, Sex hormone binding globulin (SHBG), Cortisol, TSH

  2. metabolic profile [ Time Frame: within 6 weeks ]
    total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, insulin, glucose

  3. ovarian reserve [ Time Frame: within 6 weeks ]
    anti mullerian hormone, FSH and antral follicle count.


Secondary Outcome Measures :
  1. autoimmunity in WHO 3- POI patients [ Time Frame: within 3 months ]
    antithyroid peroxidase, antiadrenal, antiparietal and antiovarian antibodies

  2. bone density in WHO 3- POI patients [ Time Frame: within 3 months ]
    a dual-energy x-ray absorptiometry (DEXA) scan

  3. genotype in WHO 3 POI patients [ Time Frame: within 3 months ]
    karotype, fragile X mental retardation 1 gene premutation carriership


Biospecimen Retention:   Samples With DNA
6 x 500 μL serum, 2 x 500 μL EDTAplasma en 3 x 900 μL celpellet


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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.
Criteria

Inclusion Criteria:

WHO I Hypogonadotropic hypoestrogenic status (previously: "hypothalamic amenorrhea")

  1. Low to normal serum 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 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:

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

WHO III

  1. POI: defined as secondary amenorrhea before the age of 40 years and basal FSH > 40 IU/L.
  2. IOF: defined as normal ovulatory cycles with raised basal FSH > 12 IU/L before the age of 40 years.
  3. TOF: defined as irregular cycles with raised basal FSH > 12 IU/L before the age of 40 years.
  4. 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.
  5. Early menopause: menopause occurring between age 40 and 45 years.
  6. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309047


Locations
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Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508GA
Contact: Bart CJ Fauser, professor    +31887557524    b.c.fauser@umcutrecht.nl   
Contact: Nadine MP Daan, MD    +31877551044    n.m.p.daan@umcutrecht.nl   
Principal Investigator: Bart CJ Fauser, prof MD PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
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Principal Investigator: Bart CJ Fauser, professor UMC Utrecht
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bart CJM Fauser, professor BCJM Fauser, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02309047    
Other Study ID Numbers: 12-645
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Additional relevant MeSH terms:
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Anovulation
Amenorrhea
Oligomenorrhea
Menstruation Disturbances
Pathologic Processes
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases