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| Name | Class |
|---|---|
| Semmelweis University | OTHER |
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 procedure inducing a tolerance to the hormones the women are sensitive to.
This study is designed to evaluate the safety and the ability of the EVE- Skin-Test Panel to detect sensitivity to female sex hormones in subjects with Unexplained Recurrent Pregnancy Loss (URPL) and in Control parous, healthy women.
The Skin Test Panel includes four female hormones and three control solutions.
Hormones from the Skin Test Panel are injected intradermally during the luteal phase of the subject's menstrual cycle. The skin reactions are examined by physician for erythema and wheal after 20 minutes and 48 hours and self-assessed by the patient daily for the following month.
Skin response monthly data is analyzed and compared between unexplained recurrent pregnancy loss (UPRL) and healthy groups.
Following achievement of the significant differences between both groups the immune profile of the healthy and UPRL subjects will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control group | Experimental |
| |
| UPRL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin test panel | Drug | Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups | 1 month | |
| Measurement of cytokine production in subjects from UPRL and Control groups | 1 month |
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Inclusion Criteria:
For both groups:
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:
For healthy group:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Füst, Prof. | Contact | 361-212-9351 | fustge@kut.sote.hu |
| Name | Affiliation | Role |
|---|---|---|
| János Rigó, Prof. | Gynecology and Obstetrics Dept, Semmelweis University, Budapest, Hungary | Principal Investigator |
| Henriette Farkas, Prof. | 3rd Dept of Internal Medicine, Semmelweis University, Budapest, Hungary |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine | Recruiting | Budapest | H1125 | Hungary |
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| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Skin test panel | Drug | Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones:
|
|
| D007154 | Immune System Diseases |