Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:
• 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
Locations
United States
Connecticut
Yale Fertility Center
RECRUITING
Orange
Contact Information
Primary
Hugh S Taylor, MD
hugh.taylor@yale.edu
(203)-785-6949
Backup
Michele Frank, BSN
Michele.Frank@yale.edu
(203)-785-6949
Time Frame
Start Date:2023-11-01
Estimated Completion Date:2026-12
Participants
Target number of participants:30
Treatments
Experimental: Endometrial Disorders
Three groups of patients, with 10 subjects per group:~1. Asherman's syndrome, as classified by the American Society of Reproductive Medicine (ASRM) by extent of uterine cavity involvement and adhesion type. Specifically, refractory Asherman's syndrome: patients who have had at least one operative hysteroscopy which was unsuccessful.~2. Atrophic endometrium, as defined by maximal endometrial lining thickness ≤6mm documented in at least 2 cycles on either:~ * Day of luteinizing hormone (LH) surge in natural cycle~ * Day of human chorionic gonadotropin (hCG) trigger in the setting of fresh IVF cycle~ * Day 14 of estradiol in the setting of frozen embryo transfer things (FET) cycles~3. Recurrent implantation failure, defined as failure to achieve a clinical pregnancy after transfer of at least four good-quality embryos in a minimum of three fresh or frozen transfer cycles in a woman under 40 years