Clinical trial NCT04045821: 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
Overall status: TERMINATED
Phase: NA
Conditions: Infertility of Uterine Origin
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Endometrial thickness
timeFrame: measured on day prior to progesterone initiation during frozen embryo transfer cycle
Secondary outcomes:
measure: number of participants with a chemical pregnancy
timeFrame: 9-11 days post embryo transfer
measure: number of participants with a clinical pregnancy
timeFrame: seen as early as 18 days post embryo transfer
measure: number of participants with a live births
timeFrame: typically 9 months from embryo transfer
measure: endometrial volume
timeFrame: measured at baseline visit during cycle 1 (one month) and after progesterone initiation during cycle 4 (one month)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Reproductive Medicine Associates of Northern California
state: California
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: Philadelphia
country: United States
facility: Reproductive Medicine Associates of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Brent Hanson, MD
role: STUDY_DIRECTOR
References: