Effects of Co-treatment With Aromatase Inhibitor or Progestin on Endometrial abv3-integrin Expressions in Women With Recurrent Implantation Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- endometrial abv3-integrin expression expressions
研究概览
简要总结
To compare the abv3-integrin expression in endometrium tissue among RIF women between the GnRH analogue with Aromatase Inhibitor (Group A) , GnRH analogue with progesterone (Group B) and GnRH analogue alone as control group (Group C)
详细描述
i. To determine the abv3-integrin expression isolated from endometrium tissue from women with RIF prior to medical therapy.
ii. To determine the abv3-integrin expression isolated from endometrium tissue from Group A, Group B and Group C following the medical therapy.
iii. To compare the abv3-integrin expression from endometrium tissue obtained from Group A, B and C following the medical therapy.
iv. To compare the implantation rates among Group A, B and C following the medical therapy.
v. To compare the ongoing pregnancy among Group A, B and C following the medical therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of 18 to 40 years of age
- •No significant pre-existing major medical.
- •Diagnosed as recurrent implantation failure - at least two or more failure of achieving pregnancy following embryo transfer (ET) despite the optimum endometrial thickness and good quality of embryo (unexplained).
- •Regular menstrual cycle atleast 3 months prior to treatment
- •Not taking any hormonal treatment for atlest 3months prior to recruitment
- •Agreed to participate
排除标准
- •Concurrent significant pre-existing major medical conditions such as uncontrolled diabetes, active systemic lupus erythematosus (SLE) or Anti Phospholipid Syndrome (APS) that will interfere with implantation.
- •Poor quality of embryo
- •Suboptimal endometrial thickness(<8mm) during the embryo transfer (ET).
- •On hormonal therapy prior to recruitment.
- •Not agreed to participate
研究组 & 干预措施
Group A (GnRH analogue with Aromatase Inhibitor
This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed by Letroloze 10mg OD for 3 months
干预措施: GNRH Analoge, Duphaston, Letrozole (Drug)
Group B (GnRH analogue with Progesterone
This group of candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) followed Duphaston 10mg BD by for 3 months
干预措施: GNRH Analoge, Duphaston, Letrozole (Drug)
Group C (GnRH analogue alone)
This is a control group. The candidates will be administered a single dose of 11.25mg GNRH analoge (Lucrin) only.
干预措施: GNRH Analoge, Duphaston, Letrozole (Drug)
结局指标
主要结局
endometrial abv3-integrin expression expressions
时间窗: 12 months
pre and post treatment endometrial abv3-integrin expressions
次要结局
未报告次要终点
研究者
Thines Ramalingam
Doctor
Universiti Kebangsaan Malaysia Medical Centre