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

NCT01175759 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-08-05

No results posted yet for this study

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.

Conditions

  • Abortion, Recurrent

Interventions

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)

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)

Sponsors & Collaborators

  • Semmelweis University

    collaborator OTHER

  • EVE Medical Systems Ltd.

    lead INDUSTRY

Principal Investigators

  • János Rigó, Prof. · Gynecology and Obstetrics Dept, Semmelweis University, Budapest, Hungary

  • Henriette Farkas, Prof. · 3rd Dept of Internal Medicine, Semmelweis University, Budapest, Hungary

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-06-30
Completion
2011-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01175759 on ClinicalTrials.gov