Endometrial Rejuvenation Study

Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining

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.

Study Overview

• Status: Terminated
• Conditions: Infertility of Uterine Origin
• Intervention / Treatment: Drug: Normal saline; Procedure: dilation and curettage; Drug: AMD3100

Detailed Description

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
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94105
      • Reproductive Medicine Associates of Northern California
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Reproductive Medicine Associates of New Jersey
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Reproductive Medicine Associates of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	Drug: Normal saline; Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose; Procedure: dilation and curettage; all participants will undergo routine D&C procedure; Other Names: D&C
EXPERIMENTAL: Intervention; Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed.	Procedure: dilation and curettage; all participants will undergo routine D&C procedure; Other Names: D&C; Drug: AMD3100; Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endometrial thickness	measurement of endometrial thickness	measured on day prior to progesterone initiation during frozen embryo transfer cycle

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2020
• Primary Completion (ACTUAL): January 27, 2021
• Study Completion (ACTUAL): May 4, 2021

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (ACTUAL): August 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 18, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Plerixafor
• Other Study ID Numbers: RMA-2019-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No