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Report for Clinical Trial NCT01175759

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01175759 Abortion, Recurrent
MeSH: Abortion, Habitual Hypersensitivity
HPO: Allergy

2 Interventions

Name: Skin test panel

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)

Type: Drug

Healthy control group

Name: Skin test panel

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)

Type: Drug

UPRL


Primary Outcomes

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

Time: 1 month

Secondary Outcomes

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

Time: 1 month

Measure: Measurement of cytokine production in subjects from UPRL and Control groups

Time: 1 month

Purpose: Diagnostic

Allocation: Non-Randomized

Factorial Assignment


There are 2 SNPs

SNPs


1 C677T

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. --- C677T ---


2 G20201A

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. --- C677T --- --- G20201A ---



HPO Nodes


HPO:
Allergy
Genes 21
CHD1 TGM5 ADA PLA2G7 MTOR FOXP3 PGM3 CARMIL2 SIK3 CCDC28B BBS1 NRXN1 IL4R COX4I2 MS4A2 PLCG2 SPINK5 CSTA CNTNAP2 RBM8A PGM3