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To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
Patients with a history of thin endometrium will be randomized to either an intrauterine infusion of PRP vs. a placebo infusion of normal saline. This is a double-blind, placebo controlled prospective RCT. Patients will then proceed with a frozen embryo transfer of a single euploid embryo per routine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Active Comparator | an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group |
|
| Control Group | Placebo Comparator | an intrauterine infusion of normal saline will be administered to this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma Intrauterine infusion | Other | an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group of participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial Thickness during frozen embryo transfer | peak endometrial thickness prior to initiation of progesterone | during the proliferative phase of the frozen embryo transfer cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained implantation rate | presence of fetal heart beat upon discharge from care | approximately 9 weeks gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine V Whitehead, BSN, RN | Contact | 19736562841 | clinicalresearchteam@ivirma.com | |
| Caroline Zuckerman, BS | Contact | 19736562841 | clinicalresearchteam@ivirma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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| Normal saline Intrauterine infusion | Other | an intrauterine infusion of normal saline will be administered to this group of participants |
|