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

Primary Purpose

Abortion, Recurrent

Status

Unknown status

Phase

Phase 2

Locations

Hungary

Study Type

Interventional

Intervention

Skin test panel

About this trial

This is an interventional diagnostic trial for Abortion, Recurrent focused on measuring Unexplained Recurrent Pregnancy Loss, Recurrent Abortions, Recurrent Miscarriages, Hormones, Skin tests, Allergen, Immunotherapy, Hypersensitivity, Skin reaction

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

For both groups:

Between ages of 20 to 40
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:

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.
No hormonal therapy (estrogen or progesterone) for at least two months prior to screening.
Significant medical or psychiatric disease.
Severe allergies or an inflammatory illness at the time of enrollment

For healthy group:

Women who are pregnant or lactating on the day of screening
Abnormal routine blood tests

For UPRL:

Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A))
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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Healthy control group

UPRL

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups

Secondary Outcome Measures

Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups

Measurement of cytokine production in subjects from UPRL and Control groups

Full Information

NCT ID

NCT01175759

First Posted

June 15, 2010

Last Updated

August 4, 2010

Sponsor

EVE Medical Systems Ltd.

Collaborators

Semmelweis University

1. Study Identification

Unique Protocol Identification Number

NCT01175759

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2010

Overall Recruitment Status

Unknown status

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2011 (Anticipated)

Study Completion Date

December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

EVE Medical Systems Ltd.

Collaborators

Semmelweis University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abortion, Recurrent

Keywords

Unexplained Recurrent Pregnancy Loss, Recurrent Abortions, Recurrent Miscarriages, Hormones, Skin tests, Allergen, Immunotherapy, Hypersensitivity, Skin reaction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Healthy control group

Arm Type

Experimental

Arm Title

UPRL

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Skin test panel

Intervention Description

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)

Intervention Type

Drug

Intervention Name(s)

Skin test panel

Intervention Description

Primary Outcome Measure Information:

Title

Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Frequency and severity of adverse events following a skin test procedure in subjects from URPL and Control groups

Time Frame

1 month

Title

Measurement of cytokine production in subjects from UPRL and Control groups

Time Frame

1 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For both groups: Between ages of 20 to 40 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: 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. No hormonal therapy (estrogen or progesterone) for at least two months prior to screening. Significant medical or psychiatric disease. Severe allergies or an inflammatory illness at the time of enrollment For healthy group: Women who are pregnant or lactating on the day of screening Abnormal routine blood tests For UPRL: Hereditary thrombophilias (Factor V Leiden, Activated protein C resistance, MTHFR (C677T), Factor II mutation (G20201A)) One or more abnormal test from the list below: Karyotype of either parent (normal: 46XX or 46XY) Glucose tolerance test (This can be altered to fasting blood sugar of 100mg/dl or less); Toxoplasmosis serology (IgM positive); Hysterosalpingogram, 3-D ultrasound or hysteroscopy, thereby excluding anatomical abnormalities, intrauterine adhesions and cervical incompetence; Thyroid function (Euthyroid levels;); Serum prolactin; Normal luteal phase of at least 12 days and plasma progesterone above 24 ng/lL Anti nuclear factor (Negative) 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

George Füst, Prof.

Phone

361-212-9351

fustge@kut.sote.hu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

János Rigó, Prof.

Organizational Affiliation

Gynecology and Obstetrics Dept, Semmelweis University, Budapest, Hungary

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Henriette Farkas, Prof.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Budapest

ZIP/Postal Code

H1125

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

George Füst, Prof.

Phone

361-212-9351

fustge@kut.sote.hu

First Name & Middle Initial & Last Name & Degree

János Rigó, Prof.

First Name & Middle Initial & Last Name & Degree

Henriette Farkas, Prof.

12. IPD Sharing Statement

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

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