The Cycle disturbances, OLigomenorrhea and Amenorrhea (COLA) Study

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 4000

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 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
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 normo-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 amenorrhoea with raised basal FSH > 12
IU/L.;When a familial component can be identified from the family history (i.e. * 3 affected relatives), the 1st and/or 2nd degree relatives will be approached for participation in the genetic screening. (for procedure; see question F1)

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).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To improve accuracy and reproducibility of diagnostic criteria for<br /><br>oligomenorrhea and amenorrhea (WHO classes I, II, and III)<br /><br>2. To better understand etiologic factors involved in cycle disturbances<br /><br>(including metabolic disturbances and ethnic variation)<br /><br>3. To better assess the extent of other female health implications in women<br /><br>with cycle disturbances (including bone density, quality of life, and<br /><br>cardiovascular risk)<br /><br>4. To identify genetic factors associated with oligomenorrhea or amenorrhea<br /><br>(using both conventional and newly developed molecular technologies)<br /><br>5. To enable long-term follow-up regarding pregnancy, children*s health by<br /><br>providing baseline (cross-sectional) data<br /><br>6. To enable long-term follow-up regarding the woman/mother by providing<br /><br>baseline (cross-sectional) data</p><br>

Secondary Outcome Measures