Do Endometrial Implantation Markers Predict in Vitro Fertilization-embryo Transfer Cycle Outcomes in Endometriosis Patients Pretreated With Leuprolide Acetate in Depot Suspension?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Patients Who Responded to Controlled Ovarian Hyperstimulation
研究概览
简要总结
This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio
详细描述
See summary
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
- None
入排标准
- 年龄范围
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertility
- •Surgical diagnosis of endometriosis
- •Normal ovarian reserve testing
- •Regular menses
排除标准
- •Irregular menses
- •Undiagnosed abnormal uterine bleeding
- •Pregnancy
- •Prior adverse reaction to any GnRH agonist
- •Ovarian cystic or solid mass > 3cm in mean diameter at study entry
- •Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry
- •Current hepatic, renal, hematologic or psychiatric disorder
研究组 & 干预措施
Group 1
Positive endometrial alpha v, beta 3 vitronectin expression. Standard controlled ovarian stimulation protocol followed by in vitro fertilization Intervention: No intervention
干预措施: No intervention (Other)
Group 2
Intervention: Positive endometrial alpha v beta 3 vitronectin expression, 3 months of leuprolide acetate in depot suspension administration prior to initiation of controlled ovarian stimulation followed by in vitro fertilization
干预措施: Leuprolide acetate in depot suspension (Drug)
Group 3
Negative endometrial alpha v, beta 3 vitronectin and administration of leuprolide acetate in depot suspension for 3 months prior to initiation of controlled ovarian stimulation
干预措施: Leuprolide acetate in depot suspension (Drug)
Group 4
Negative endometrial alpha v, beta 3 vitronectin expression and standard controlled ovarian stimulation protocol followed by in vitro fertilization. Intervention: No intervention
干预措施: No intervention (Other)
结局指标
主要结局
Patients Who Responded to Controlled Ovarian Hyperstimulation
时间窗: Evaluated at 6 1/2 weeks of pregnancy which is 4 weeks post embryo transfer.
Number of patients who responded to controlled ovarian stimulation as evidenced by implantation of embryo. Implantation confirmed by ultrasound at 6 1/2 weeks of pregnancy.
次要结局
未报告次要终点
研究者
Eric Surrey, M.D.
Medical Director
Colorado Center for Reproductive Medicine