Status:
UNKNOWN
Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
Lead Sponsor:
EVE Medical Systems Ltd.
Collaborating Sponsors:
Semmelweis University
Conditions:
Abortion, Recurrent
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
Brief Summary
The EVE- technology is intended for determination of intolerance or sensitivity to female sex hormones among women with hormone-related conditions and for further treatment by desensitization procedur...
Eligibility Criteria
Inclusion
- For both groups:
- Between ages of 20 to 40
- 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
- For both groups:
- 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.
- No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
- Significant medical or psychiatric disease.
- Severe allergies or an inflammatory illness at the time of enrollment
- For healthy group:
- Women who are pregnant or lactating on the day of screening
- Abnormal routine blood tests
- For UPRL:
- Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A))
- One or more abnormal test from the list below:
- Karyotype of either parent (normal: 46XX or 46XY)
- Glucose tolerance test (This can be altered to fasting blood sugar of 100mg/dl or less);
- Toxoplasmosis serology (IgM positive);
- Hysterosalpingogram, 3-D ultrasound or hysteroscopy, thereby excluding anatomical abnormalities, intrauterine adhesions and cervical incompetence;
- Thyroid function (Euthyroid levels;);
- Serum prolactin;
- Normal luteal phase of at least 12 days and plasma progesterone above 24 ng/lL
- Anti nuclear factor (Negative)
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01175759
Start Date
June 1 2010
End Date
December 1 2011
Last Update
August 5 2010
Active Locations (1)
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1
Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine
Budapest, Hungary, H1125