Infertility of Uterine Origin
Conditions
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.
Interventions
DRUGAMD3100
Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose
DRUGNormal saline
Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose
PROCEDUREdilation and curettage
all participants will undergo routine D&C procedure
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness | measured on day prior to progesterone initiation during frozen embryo transfer cycle | measurement of endometrial thickness |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed