Endometrial Rejuvenation Study

Infertility of Uterine Origin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04045821
• Other study ID #: RMA-2019-02
• Status: Terminated
• Phase: N/A
• Start date: January 17, 2020
• Est. completion date: May 4, 2021

Study information

• Verified date: May 2021
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 4, 2021
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility of Uterine Origin

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey
United States	Reproductive Medicine Associates of Philadelphia	Philadelphia	Pennsylvania
United States	Reproductive Medicine Associates of Northern California	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial thickness	measurement of endometrial thickness	measured on day prior to progesterone initiation during frozen embryo transfer cycle
Secondary	number of participants with a chemical pregnancy	defined by a positive bHCG	9-11 days post embryo transfer
Secondary	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
Secondary	number of participants with a live births	number of deliveries resulting from embryo transfer	typically 9 months from embryo transfer
Secondary	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)