NCT02309047

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

October 20, 2021

Status Verified

October 1, 2021

Enrollment Period

17.7 years

First QC Date

November 12, 2014

Last Update Submit

October 12, 2021

Conditions

Anovulation

Outcome Measures

Primary Outcomes (3)

  • hormonal classification

    FSH, LH, Estradiol, Progesterone,Testosterone, Androstenedione, Sex hormone binding globulin (SHBG), Cortisol, TSH

    within 6 weeks

  • metabolic profile

    total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, insulin, glucose

    within 6 weeks

  • ovarian reserve

    anti mullerian hormone, FSH and antral follicle count.

    within 6 weeks

Secondary Outcomes (3)

  • autoimmunity in WHO 3- POI patients

    within 3 months

  • bone density in WHO 3- POI patients

    within 3 months

  • genotype in WHO 3 POI patients

    within 3 months

Study Arms (1)

WHO anovulation

WHO I, II. III anovulation. See inclusion criteria

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.
  • +3 more criteria

You may not qualify if:

  • Age: younger than 18 yrs.
  • Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3508GA, Netherlands

RECRUITING

Related Publications (2)

  • Christ JP, Gunning MN, Meun C, Eijkemans MJC, van Rijn BB, Bonsel GJ, Laven JSE, Fauser BCJM. Pre-Conception Characteristics Predict Obstetrical and Neonatal Outcomes in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2019 Mar 1;104(3):809-818. doi: 10.1210/jc.2018-01787.

    PMID: 30590587DERIVED

  • Christ JP, Gunning MN, Palla G, Eijkemans MJC, Lambalk CB, Laven JSE, Fauser BCJM. Estrogen deprivation and cardiovascular disease risk in primary ovarian insufficiency. Fertil Steril. 2018 Apr;109(4):594-600.e1. doi: 10.1016/j.fertnstert.2017.11.035. Epub 2018 Mar 28.

    PMID: 29605405DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

6 x 500 μL serum, 2 x 500 μL EDTAplasma en 3 x 900 μL celpellet

MeSH Terms

Conditions

Anovulation

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Bart CJ Fauser, professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor BCJM Fauser

Study Record Dates

First Submitted

November 12, 2014

First Posted

December 5, 2014

Study Start

October 1, 2004

Primary Completion

June 1, 2022

Study Completion

August 1, 2023

Last Updated

October 20, 2021

Record last verified: 2021-10

Locations

NL(1)