Endometrial Rejuvenation Study

NCT ID: NCT04045821

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-17
• Study Completion Date: 2021-05-04

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.

Conditions

Infertility of Uterine Origin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

dilation and curettage

Intervention Type: PROCEDURE

all participants will undergo routine D\&C procedure

Intervention

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

Group Type: EXPERIMENTAL

AMD3100

Intervention Type: DRUG

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

dilation and curettage

Intervention Type: PROCEDURE

all participants will undergo routine D\&C procedure

Interventions

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

dilation and curettage

all participants will undergo routine D\&C procedure

Intervention Type: PROCEDURE

Other Intervention Names

D&C

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Reproductive Medicine Associates of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brent Hanson, MD

Role: STUDY_DIRECTOR

Reproductive Medicine Associates of New Jersey

Locations

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

Countries

United States

Other Identifiers

RMA-2019-02

Identifier Type: -

Identifier Source: org_study_id