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Recruiting EARLY_Phase 1 NCT05343572

Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium

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Trial Parameters

Condition Asherman Syndrome
Sponsor Hugh Taylor
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 90
Sex FEMALE
Min Age 18 Years
Max Age 40 Years
Start Date 2023-11-01
Completion 2026-12
Interventions
Plerixafor

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Brief 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 Criteria

Inclusion Criteria: * Healthy, non pregnant females * ages ≥18 and ≤40 years old at time of enrollment * with either AS, AE, or RIF 1. For AS: surgical history of intrauterine trauma/infection, hypo/amenorrhea, intra-uterine adhesions 2. for AE: US documentation of persistent, \<6mm endometrial thickness 3. 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 Criteria: * 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 pro

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