Endometrial Rejuvenation Study

Reproductive Medicine Associates of New Jersey3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Infertility of Uterine Origin

Interventions

AMD3100DRUG

Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose

Normal salineDRUG

Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose

dilation and curettagePROCEDURE

all participants will undergo routine D\&C procedure

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst. 2. 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. 3. Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle. 4. Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017. Exclusion Criteria: 1. Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles. 2. Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017. 3. No euploid embryos available for transfer. 4. Mullerian anomalies, excluding arcuate uterus 5. Submucosal fibroids 6. History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section 7. Communicating hydrosalpinx without plans for surgical correction prior to study enrollment. 8. Failure of patient to agree to enrollment in study with written consent. 9. History of drug sensitivity or adverse reaction to AMD3100 (plerixafor). 10. Pregnancy

Locations (3)

Reproductive Medicine Associates of Northern California

San Francisco, California, United States

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, United States

Reproductive Medicine Associates of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Endometrial thickness

measurement of endometrial thickness

Time frame: measured on day prior to progesterone initiation during frozen embryo transfer cycle

Secondary Outcomes

number of participants with a chemical pregnancy

defined by a positive bHCG

Time frame: 9-11 days post embryo transfer

number of participants with a clinical pregnancy

defined as the presence of an intrauterine gestational sac

Time frame: seen as early as 18 days post embryo transfer

number of participants with a live births

number of deliveries resulting from embryo transfer

Time frame: typically 9 months from embryo transfer

endometrial volume

measurement of uterine endometrium based on 3D ultrasound

Time frame: measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month)

Data from ClinicalTrials.gov

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