Bone Marrow Derived Stem Cells Mobilization for Treatment of Abnormal Endometrium
Sponsored by Hugh Taylor
About this trial
Last updated 2 years ago
Study ID
2000026217
Status
Not yet recruiting
Type
Interventional
Phase
Early Phase 1
Placebo
No
Accepting
18 to 40 Years
Female
Trial Timing
Started 2 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