Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
NCT ID:
NCT01175759
Eligibility Criteria:
Inclusion Criteria:
For both groups:
1. Between ages of 20 to 40
2. Willing to participate as shown by signing the informed consent form.
For healthy group:
Parous subjects without premenstrual syndrome, as per medical history and subject's report ( PMS questionnaire)
For UPRL:
Women with three or more documented early pregnancy losses.
Exclusion Criteria:
For both groups:
1. No hormonal contraceptives (either OC or hormonal IUD (Mirena)), no psychotropic agents (e.g. Antidepressants, anxiolytics, or lithium carbonate) for at least two months prior to screening.
2. No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
3. Significant medical or psychiatric disease.
4. Severe allergies or an inflammatory illness at the time of enrollment
For healthy group:
1. Women who are pregnant or lactating on the day of screening
2. Abnormal routine blood tests
For UPRL:
1. Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A))
2. One or more abnormal test from the list below:
1. Karyotype of either parent (normal: 46XX or 46XY)
2. Glucose tolerance test (This can be altered to fasting blood sugar of 100mg/dl or less);
3. Toxoplasmosis serology (IgM positive);
4. Hysterosalpingogram, 3-D ultrasound or hysteroscopy, thereby excluding anatomical abnormalities, intrauterine adhesions and cervical incompetence;
5. Thyroid function (Euthyroid levels;);
6. Serum prolactin;
7. Normal luteal phase of at least 12 days and plasma progesterone above 24 ng/lL
8. Anti nuclear factor (Negative)
9. Anticardiolipin antibody by Elisa testing (cut off value \<13 GPLu/mL and \<7.6 MPLu/mlL) and Lupus anticoagulant (according to Kaolin clotting time (KCT), Russell's viper venom tome (RVVT) or APTT.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT01175759
Study Brief:
Protocol Section:
NCT01175759