Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Endometrial thickness
研究概览
简要总结
To evaluate the response of the endometrial lining after subcutaneous administration of the medication AMD3100. This medication mobilizes stem cells and will be used in a population of infertile women with a thin endometrium who are undergoing frozen-thawed embryo transfer. The investigators will assess associations between response to stem cell mobilization and pregnancy outcomes.
详细描述
This study seeks to help each participant build a better endometrial lining which is suitable to implantation and maintenance of a healthy pregnancy. While animal models demonstrating the effectiveness of stem cell recruitment on improved endometrial thickness and pregnancy outcomes are plentiful, human studies are lacking. The use of stem cells from the peripheral circulation in humans could potentially allow for enhanced endometrial proliferation. The objective of this study is to perform a prospective randomized, controlled trial to evaluate the response of the endometrial lining after subcutaneous administration of AMD3100 (plerixafor). AMD3100 is an immunostimulant used to mobilize hematopoietic stem cells in the bloodstream. This intervention will be studied in a population of infertile women with a thin endometrium who have failed previous embryo transfer cycles and are undergoing a frozen-thawed embryo transfer. This study seeks to evaluate both the endometrial response to stem cell mobilization via AMD3100 as well as pregnancy outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
- •Patients who have previously undergone at least 2 unsuccessful frozen-thawed embryo transfer cycles, defined as failure to achieve a clinical pregnancy (visualization of intrauterine gestational sac on ultrasound) or a cancelled embryo transfer cycle due to inadequate endometrial thickness.
- •Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
- •Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.
排除标准
- •Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
- •Most recent unsuccessful frozen-thawed embryo transfer prior to January 1,
- •No euploid embryos available for transfer.
- •Mullerian anomalies, excluding arcuate uterus
- •Submucosal fibroids
- •History of uterine surgery, excluding polypectomy, D&C, and Cesarean section
- •Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- •Failure of patient to agree to enrollment in study with written consent.
- •History of drug sensitivity or adverse reaction to AMD3100 (plerixafor).
研究组 & 干预措施
Control
Patients in this arm will not receive the study drug. A placebo of normal saline will be injected subcutaneously and the D&C procedure will be completed.
干预措施: dilation and curettage (Procedure)
Control
Patients in this arm will not receive the study drug. A placebo of normal saline will be injected subcutaneously and the D&C procedure will be completed.
干预措施: Normal saline (Drug)
Intervention
Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed.
干预措施: AMD3100 (Drug)
Intervention
Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed.
干预措施: dilation and curettage (Procedure)
结局指标
主要结局
Endometrial thickness
时间窗: measured on day prior to progesterone initiation during frozen embryo transfer cycle
measurement of endometrial thickness
次要结局
- number of participants with a chemical pregnancy(9-11 days post embryo transfer)
- number of participants with a clinical pregnancy(seen as early as 18 days post embryo transfer)
- number of participants with a live births(typically 9 months from embryo transfer)
- endometrial volume(measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month))