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Endometrial Rejuvenation Study

Primary Purpose

Infertility of Uterine Origin

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMD3100
Normal saline
dilation and curettage
Sponsored by
Reproductive Medicine Associates of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility of Uterine Origin

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Reproductive Medicine Associates of Northern California
  • Reproductive Medicine Associates of New Jersey
  • Reproductive Medicine Associates of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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.

Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed.

Outcomes

Primary Outcome Measures

Endometrial thickness
measurement of endometrial thickness

Secondary Outcome Measures

number of participants with a chemical pregnancy
defined by a positive bHCG
number of participants with a clinical pregnancy
defined as the presence of an intrauterine gestational sac
number of participants with a live births
number of deliveries resulting from embryo transfer
endometrial volume
measurement of uterine endometrium based on 3D ultrasound

Full Information

First Posted
July 25, 2019
Last Updated
May 18, 2021
Sponsor
Reproductive Medicine Associates of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04045821
Brief Title
Endometrial Rejuvenation Study
Official Title
Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
January 17, 2020 (Actual)
Primary Completion Date
January 27, 2021 (Actual)
Study Completion Date
May 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Medicine Associates of New Jersey

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility of Uterine Origin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D&C procedure will be completed.
Intervention Type
Drug
Intervention Name(s)
AMD3100
Intervention Description
Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose
Intervention Type
Procedure
Intervention Name(s)
dilation and curettage
Other Intervention Name(s)
D&C
Intervention Description
all participants will undergo routine D&C procedure
Primary Outcome Measure Information:
Title
Endometrial thickness
Description
measurement of endometrial thickness
Time Frame
measured on day prior to progesterone initiation during frozen embryo transfer cycle
Secondary Outcome Measure Information:
Title
number of participants with a chemical pregnancy
Description
defined by a positive bHCG
Time Frame
9-11 days post embryo transfer
Title
number of participants with a clinical pregnancy
Description
defined as the presence of an intrauterine gestational sac
Time Frame
seen as early as 18 days post embryo transfer
Title
number of participants with a live births
Description
number of deliveries resulting from embryo transfer
Time Frame
typically 9 months from embryo transfer
Title
endometrial volume
Description
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)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
all participants must be biologically female and possess a uterus
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles. Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017. 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). Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brent Hanson, MD
Organizational Affiliation
Reproductive Medicine Associates of New Jersey
Official's Role
Study Director
Facility Information:
Facility Name
Reproductive Medicine Associates of Northern California
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
Facility Name
Reproductive Medicine Associates of New Jersey
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Reproductive Medicine Associates of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Endometrial Rejuvenation Study

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