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

NCT ID: NCT01175759

Last Updated: 2010-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-12-31

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.

Conditions

Abortion, Recurrent

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy control group

Group Type: EXPERIMENTAL

Skin test panel

Intervention Type: DRUG

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)

UPRL

Group Type: EXPERIMENTAL

Skin test panel

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Semmelweis University

OTHER

Sponsor Role: collaborator

EVE Medical Systems Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

EVE Medical systems Ltd.

Principal Investigators

János Rigó, Prof.

Role: PRINCIPAL_INVESTIGATOR

Gynecology and Obstetrics Dept, Semmelweis University, Budapest, Hungary

Henriette Farkas, Prof.

Role: PRINCIPAL_INVESTIGATOR

3rd Dept of Internal Medicine, Semmelweis University, Budapest, Hungary

Locations

Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine

Budapest, , Hungary

Site Status: RECRUITING

Countries

Hungary

Central Contacts

George Füst, Prof.

Role: CONTACT

fustge@kut.sote.hu

361-212-9351

Facility Contacts

George Füst, Prof.

Role: primary

fustge@kut.sote.hu

361-212-9351

Other Identifiers

34/2009

Identifier Type: -

Identifier Source: org_study_id