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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.

Tracking Information
First Submitted Date  ICMJE June 15, 2010
First Posted Date  ICMJE August 5, 2010
Last Update Posted Date August 5, 2010
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2010)
  • Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups [ Time Frame: 1 month ]
  • Measurement of cytokine production in subjects from UPRL and Control groups [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Hypersensitivity to Female Sex Hormones in Women With Unexplained Recurrent Pregnancy Loss
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Abortion, Recurrent
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Experimental: Healthy control group
    Intervention: Drug: Skin test panel
  • Experimental: UPRL
    Intervention: Drug: Skin test panel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 4, 2010)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01175759
Other Study ID Numbers  ICMJE 34/2009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Yonit Bomstein, EVE Medical systems Ltd.
Study Sponsor  ICMJE EVE Medical Systems Ltd.
Collaborators  ICMJE Semmelweis University
Investigators  ICMJE
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
PRS Account EVE Medical Systems Ltd.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP