Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure
Hugh Taylor
90 participants
Nov 1, 2023
INTERVENTIONAL
Conditions
Summary
This study will assess the use of autologous bone marrow stem cells mobilization using 1,1'-\[1,4-phenylenebis-(methylene)\]-bis-1,4,8,11-tetraazacyclotetradecane (PLERIXAFOR) as an effective medical therapy for the treatment of Asherman's Syndrome (AS), Atrophic Endometrium (AE) and Recurrent Implantation Failure (RIF).
Eligibility
Inclusion Criteria6
- Healthy, non pregnant females
- ages ≥18 and ≤40 years old at time of enrollment
- with either AS, AE, or RIF
- For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions
- for AE: US documentation of persistent, \<6mm endometrial thickness
- for RIF: failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles in a woman under 40 years and currently being treated at Yale Fertility Clinic
Exclusion Criteria8
- Presence of hydrosalpinx (diagnosed by radiographic or ultrasound imaging)
- Endometriosis (diagnosed by previous surgery,)
- Diminished ovarian reserve (AMH\<1ng/ml or follicle stimulating hormone (FSH)\>10)
- History of genital tuberculosis or any ultrasound evidence of congenital uterine anomaly
- Submucous or intracavitary fibroid, polyps
- Currently pregnant
- Personal history of thrombophilia or sickle cell disease
- Inability to provide informed consent
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Interventions
A 20mg single dose of PLERIXAFOR is administered subcutaneously the evening prior to scheduled standard of care surgery for women with AS, AE or RIF for peripheral mobilization of stem cells. For subjects weighing \>83 kilogram, the dosing is a single dose of 0.24 milligram per kilogram.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05343572