Endometrial Rejuvenation Study

• Status: Terminated
• Trial end date: 2021-05-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reproductive Medicine Associates of New Jersey
• Treatments: Plerixafor; Plerixafor octahydrochloride

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