UnknownNot Applicable

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

Netherlands5,000 participantsStarted 2004-10

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion criteria

✓. Low to normal serum FSH concentrations
✓. Low serum estradiol concentrations
✓. 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.
✓. Oligo-/anovulation
✓. Clinical and/ or biochemical hyperandrogenism
✓. Polycystic ovaries on ultrasonography

What they're measuring

hormonal classification

Timeframe: within 6 weeks

metabolic profile

Timeframe: within 6 weeks

ovarian reserve

Timeframe: within 6 weeks

Trial details

NCT IDNCT02309047

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06

View on ClinicalTrials.gov More Anovulation trials