A Controlled Trial on Adenomyosis Treatment Comparing Aromatase Inhibitor Plus GnRH Analogue Versus GnRH Analog Alone
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- pregnancy after embryo transfer
研究概览
简要总结
With this study the investigators want to test which is the best medical treatment for symptomatic adenomyosis affecting women undergoing IVF and with previous implantation failure, between Aromatase inhibitor plus GnRH analog versus GnRH alone, in term pregnancy rate and uterine volume reduction.
详细描述
Recently it has been shown that adenomyosis negatively affects the pregnancy rate in IVF cycles. The investigators used in the past for the treatment of other benign gynecological diseases such as endometriosis and uterine myomas a combined therapy with Aromatase inhibitor plus GnRH analog. With this study the investigators want evaluate which is the best way to treat adenomyosis in order to obtain a higher pregnancy rate in women with symptomatic adenomyosis undergoing IVF who failed a previous IVF attempt. For these reasons the investigators set this controlled trial between GnRH analog plus Aromatase Inhibitor (3.75 mg monthly of Leuprolide plus 1.0mg day of Anastrazole for 3 months) versus an active comparator as GnRH analog alone (3.75 mg monthly of Leuprolide for 3 months) after the treatment patients will undergo embryo transfer of a cryopreserved blastocyst in a previous IVF cycle, and will be followed up for uterine dimension reduction and pain symptom reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patients will take similar kind medications by an indipendent person
入排标准
- 年龄范围
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with healty conditions
- •Adenomyosis
- •increased uterine dimensions
- •recurrent implantation failure
排除标准
- •presence of systemic diseases
研究组 & 干预措施
GnRH analog alone
control group treated with GnRH analog alone
干预措施: GnRH analog (11.25mg Leuprolide acetate) (Drug)
Aromatase inhibitor plus GnRH analog
experimental group treated with aromatase inhibitor plus GnRH analog
干预措施: Aromatase inhibitor and GnRH analog (Drug)
Aromatase inhibitor plus GnRH analog
experimental group treated with aromatase inhibitor plus GnRH analog
干预措施: Aromatase and GnRH analog (11.25mg Leuprolide acetate) (Drug)
结局指标
主要结局
pregnancy after embryo transfer
时间窗: 12 months
after treatment patients undergo embryo transfer of a cryopreservad blastocyst
次要结局
- uterine volume reduction(12 months)