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

NCT01175759 | Unknown Phase 2

• 1 other identifier: 34/2009
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (2)

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

  1 month

• Measurement of cytokine production in subjects from UPRL and Control groups

  1 month

Study Arms (2)

Healthy control group

EXPERIMENTAL

Drug: Skin test panel

UPRL

EXPERIMENTAL

Drug: Skin test panel

Interventions

Skin test panel 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)

Healthy control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EVE Medical Systems Ltd.: lead
• Semmelweis University: collaborator

Study Sites (1)

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

Budapest, H1125, Hungary

RECRUITING

MeSH Terms

Conditions

Abortion, Habitual; Hypersensitivity

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Füst, Prof.

CONTACT

361-212-9351; fustge@kut.sote.hu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: August 5, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 5, 2010

Record last verified: 2010-06

Locations

HU (1)