Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Abortion, Recurrent |
Drug: Skin test panel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of the Efficacy and Safety of the EVE- Skin-Test Panel in Detecting Sensitivity to Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss |
- Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Measurement of cytokine production in subjects from UPRL and Control groups [ Time Frame: 1 month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Healthy control group |
Drug: Skin test panel
Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones:
|
| Experimental: UPRL |
Drug: Skin test panel
Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators. Hormones:
|
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 Criteria:
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.
Contacts and Locations| Contact: George Füst, Prof. | 361-212-9351 | fustge@kut.sote.hu |
| Hungary | |
| Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine | Recruiting |
| Budapest, Hungary, H1125 | |
| Contact: George Füst, Prof. 361-212-9351 fustge@kut.sote.hu | |
| Principal Investigator: János Rigó, Prof. | |
| Principal Investigator: Henriette Farkas, Prof. | |
| Principal Investigator: | 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Yonit Bomstein, EVE Medical systems Ltd. |
| ClinicalTrials.gov Identifier: | NCT01175759 History of Changes |
| Other Study ID Numbers: | 34/2009 |
| Study First Received: | June 15, 2010 |
| Last Updated: | August 4, 2010 |
| Health Authority: | Hungary: Institutional Ethics Committee |
Keywords provided by EVE Medical Systems Ltd.:
|
Unexplained Recurrent Pregnancy Loss Recurrent Abortions Recurrent Miscarriages Hormones Skin tests |
Allergen Immunotherapy Hypersensitivity Skin reaction |
Additional relevant MeSH terms:
|
Abortion, Habitual Hypersensitivity Abortion, Spontaneous Pregnancy Complications Immune System Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013