Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Sponsored by Hugh Taylor
About this trial
Last updated 6 months ago
Study ID
2000026217
Status
Recruiting
Type
Interventional
Phase
Early Phase 1
Placebo
No
Accepting
18 to 40 Years
Female
Trial Timing
Started 3 years ago
What is this trial about?
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).
What are the participation requirements?
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 provide informed consent