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Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss

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ClinicalTrials.gov Identifier: NCT01175759
Recruitment Status : Unknown
Verified June 2010 by EVE Medical Systems Ltd..
Recruitment status was:  Recruiting
First Posted : August 5, 2010
Last Update Posted : August 5, 2010
Sponsor:
Collaborator:
Semmelweis University
Information provided by:
EVE Medical Systems Ltd.

Study Description
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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 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 or disease Intervention/treatment Phase
Abortion, Recurrent Drug: Skin test panel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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:

  1. Progesterone 1mmol/L
  2. Estradiol 1mmol/L
  3. Estrone 3mmol/L

  4. Estriol 3mmol/l

    Controls:

  5. Saline (NaCl) 0.9%
  6. Ethyl Oleate with 10% Benzyl Alcohol
  7. Histamine phosphate 1mg/ml (epicutaneous- prick test)
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:

  1. Progesterone 1mmol/L
  2. Estradiol 1mmol/L
  3. Estrone 3mmol/L

  4. Estriol 3mmol/l

    Controls:

  5. Saline (NaCl) 0.9%
  6. Ethyl Oleate with 10% Benzyl Alcohol
  7. Histamine phosphate 1mg/ml (epicutaneous- prick test)


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups [ Time Frame: 1 month ]
  2. Measurement of cytokine production in subjects from UPRL and Control groups [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175759


Contacts
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Contact: George Füst, Prof. 361-212-9351 fustge@kut.sote.hu

Locations
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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.         
Sponsors and Collaborators
EVE Medical Systems Ltd.
Semmelweis University
Investigators
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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
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Additional Information:

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Responsible Party: Dr. Yonit Bomstein, EVE Medical systems Ltd.
ClinicalTrials.gov Identifier: NCT01175759    
Other Study ID Numbers: 34/2009
First Posted: August 5, 2010    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: June 2010
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:
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Abortion, Habitual
Hypersensitivity
Recurrence
Disease Attributes
 Pathologic Processes
Immune System Diseases
Abortion, Spontaneous
Pregnancy Complications