Endometrial Rejuvenation Study

Not Applicable

Terminated

• Conditions: Infertility of Uterine Origin
• Interventions: Drug: Normal saline; Drug: AMD3100; Procedure: dilation and curettage

• Registration Number: NCT04045821
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-06
• Study Start: 2020-01-17
• Primary Completion: 2021-01-27
• Status Verified: 2021-05
• Study Completion: 2021-05-04
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Normal saline	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.
Intervention	AMD3100	Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D\&C procedure will be completed.
Control	dilation and curettage	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.
Intervention	dilation and curettage	Patients in this arm will receive a dose of the study drug, AMD3100, injected subcutaneously and the D\&C procedure will be completed.

Primary Outcome Measures

Name	Time	Method
Endometrial thickness	measured on day prior to progesterone initiation during frozen embryo transfer cycle	measurement of endometrial thickness

Secondary Outcome Measures

Name	Time	Method
number of participants with a chemical pregnancy	9-11 days post embryo transfer	defined by a positive bHCG
number of participants with a clinical pregnancy	seen as early as 18 days post embryo transfer	defined as the presence of an intrauterine gestational sac
number of participants with a live births	typically 9 months from embryo transfer	number of deliveries resulting from embryo transfer
endometrial volume	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

Trial Locations

Locations (3)

Reproductive Medicine Associates of Northern California; 🇺🇸 San Francisco, California, United States

Reproductive Medicine Associates of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States