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Endometrial Rejuvenation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045821
Recruitment Status : Terminated (low enrollment)
First Posted : August 6, 2019
Last Update Posted : May 19, 2021
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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.

Condition or disease Intervention/treatment Phase
Infertility of Uterine Origin Drug: AMD3100 Drug: Normal saline Procedure: dilation and curettage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endometrial Response Following Use of the Stem Cell Mobilizing Agent AMD3100 in a Population of Infertile Women With a Thin Endometrial Lining
Actual Study Start Date : January 17, 2020
Actual Primary Completion Date : January 27, 2021
Actual Study Completion Date : May 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Plerixafor

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 Name: 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.
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

Procedure: dilation and curettage
all participants will undergo routine D&C procedure
Other Name: D&C




Primary Outcome Measures :
  1. Endometrial thickness [ Time Frame: measured on day prior to progesterone initiation during frozen embryo transfer cycle ]
    measurement of endometrial thickness


Secondary Outcome Measures :
  1. number of participants with a chemical pregnancy [ Time Frame: 9-11 days post embryo transfer ]
    defined by a positive bHCG

  2. number of participants with a clinical pregnancy [ Time Frame: seen as early as 18 days post embryo transfer ]
    defined as the presence of an intrauterine gestational sac

  3. number of participants with a live births [ Time Frame: typically 9 months from embryo transfer ]
    number of deliveries resulting from embryo transfer

  4. endometrial volume [ Time Frame: measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month) ]
    measurement of uterine endometrium based on 3D ultrasound



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   all participants must be biologically female and possess a uterus
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045821


Locations
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United States, California
Reproductive Medicine Associates of Northern California
San Francisco, California, United States, 94105
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
United States, Pennsylvania
Reproductive Medicine Associates of Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
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Study Director: Brent Hanson, MD Reproductive Medicine Associates of New Jersey
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT04045821    
Other Study ID Numbers: RMA-2019-02
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infertility
Plerixafor
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents