Status:
RECRUITING
Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Lead Sponsor:
Hugh Taylor
Conditions:
Asherman Syndrome
Atrophic Endometrium
Eligibility:
FEMALE
18-40 years
Phase:
EARLY_PHASE1
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05343572
Start Date
November 1 2023
End Date
December 1 2027
Last Update
November 12 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale Fertility Center
Orange, Connecticut, United States, 06477