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
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
- •Women with three or more documented early pregnancy losses.
排除标准
- •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
- •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.
研究组 & 干预措施
Healthy control group
干预措施: Skin test panel (Drug)
UPRL
干预措施: Skin test panel (Drug)
结局指标
主要结局
Number of subjects with positive wheal responses to the Skin Test Panel in URPL and Control groups
时间窗: 1 month
次要结局
- 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)