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Clinical Trials/NL-OMON37641
NL-OMON37641
Withdrawn
Not Applicable

The Cycle disturbances, OLigomenorrhea and Amenorrhea (COLA) Study - COLA

Voortplantingsgeneeskunde0 sites4,000 target enrollmentTBD
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Conditionsinfertiliteitamenorrheacycle disturbancesoligomenorrhea1001470110013326

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
infertiliteit
Sponsor
Voortplantingsgeneeskunde
Enrollment
4000
Status
Withdrawn
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Sponsor
Voortplantingsgeneeskunde

Eligibility Criteria

Inclusion Criteria

  • •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 mU/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

Exclusion Criteria

  • •\- Age: younger than 12 yrs.
  • •\- Regularly cycling women, with the exception of women with elevated basal FSH concentrations (IOF cases).
  • •\- Hypergonadotropic primary amenorrhea caused by early development disorders causing absence of ovaries and Swyer syndrome (XY).

Outcomes

Primary Outcomes

Not specified

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