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low enrollment
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 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. |
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| Intervention | Experimental | Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMD3100 | Drug | Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | measurement of endometrial thickness | measured on day prior to progesterone initiation during frozen embryo transfer cycle |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with a chemical pregnancy | defined by a positive bHCG | 9-11 days post embryo transfer |
| number of participants with a clinical pregnancy | defined as the presence of an intrauterine gestational sac |
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Inclusion Criteria:
Exclusion Criteria:
all participants must be biologically female and possess a uterus
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| Name | Affiliation | Role |
|---|---|---|
| Brent Hanson, MD | Reproductive Medicine Associates of New Jersey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of Northern California | San Francisco | California | 94105 | United States | ||
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D000077330 | Saline Solution |
| D004107 | Dilatation and Curettage |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose |
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| dilation and curettage | Procedure | all participants will undergo routine D&C procedure |
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| seen as early as 18 days post embryo transfer |
| number of participants with a live births | number of deliveries resulting from embryo transfer | typically 9 months from embryo transfer |
| endometrial volume | measurement of uterine endometrium based on 3D ultrasound | measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month) |
| Reproductive Medicine Associates of New Jersey |
| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Reproductive Medicine Associates of Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| D003475 |
| Curettage |
| D013514 | Surgical Procedures, Operative |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |