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

Abortion, Recurrent Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01175759
• Other study ID #: 34/2009
• Status: Recruiting
• Phase: Phase 2
• First received: June 15, 2010
• Last updated: August 4, 2010
• Start date: June 2010
• Est. completion date: December 2011

Study information

• Verified date: June 2010
• Source: EVE Medical Systems Ltd.
• Contact: George Füst, Prof.
• Phone: 361-212-9351
• Email: fustge[@]kut.sote.hu
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Recurrent
• Hypersensitivity

Intervention

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: Progesterone 1mmol/L Estradiol 1mmol/L Estrone 3mmol/L Estriol 3mmol/l Controls: Saline (NaCl) 0.9% Ethyl Oleate with 10% Benzyl Alcohol Histamine phosphate 1mg/ml (epicutaneous- prick test)
• 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: Progesterone 1mmol/L Estradiol 1mmol/L Estrone 3mmol/L Estriol 3mmol/l Controls: Saline (NaCl) 0.9% Ethyl Oleate with 10% Benzyl Alcohol Histamine phosphate 1mg/ml (epicutaneous- prick test)

Locations

Country	Name	City	State
Hungary	Depts. Gynecology and Obstetrics and 3rd Dept of Internal Medicine	Budapest

Sponsors (2)

Lead Sponsor	Collaborator
EVE Medical Systems Ltd.	Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups		1 month	No
Secondary	Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups		1 month	Yes
Secondary	Measurement of cytokine production in subjects from UPRL and Control groups		1 month	No