Clinical trial: Endometrial Rejuvenation Study (NCT04045821)

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
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 32-year-old woman comes to the hospital with vaginal spotting.  Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal.  Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL.  Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus.

Patient description (patient's own words): I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule.

Does the patient match the trial criteria? 0