Status:
TERMINATED
Endometrial Rejuvenation Study
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility of Uterine Origin
Eligibility:
FEMALE
18-55 years
Phase:
NA
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...
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 effectivenes...
Eligibility Criteria
Inclusion
- Patients planning to undergo a frozen-thawed embryo transfer cycle using a single euploid blastocyst.
- 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.
- Patients with a diagnosis of thin endometrial lining (less than 6 mm maximum thickness) during at least one prior unsuccessful embryo transfer cycle.
- Initiation of the most recent unsuccessful frozen-thawed embryo transfer cycle with a thin endometrial lining must have occurred after January 1, 2017.
Exclusion
- Fewer than 2 prior unsuccessful frozen-thawed embryo transfer cycles.
- Most recent unsuccessful frozen-thawed embryo transfer prior to January 1, 2017.
- No euploid embryos available for transfer.
- Mullerian anomalies, excluding arcuate uterus
- Submucosal fibroids
- History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section
- Communicating hydrosalpinx without plans for surgical correction prior to study enrollment.
- Failure of patient to agree to enrollment in study with written consent.
- History of drug sensitivity or adverse reaction to AMD3100 (plerixafor).
- Pregnancy
Key Trial Info
Start Date :
January 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2021
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04045821
Start Date
January 17 2020
End Date
May 4 2021
Last Update
May 19 2021
Active Locations (3)
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1
Reproductive Medicine Associates of Northern California
San Francisco, California, United States, 94105
2
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
3
Reproductive Medicine Associates of Philadelphia
Philadelphia, Pennsylvania, United States, 19107