Bone Marrow Derived Stem Cells Mobilization for Treatment of Asherman's Syndrome, Atrophic Endometrium, and Recurrent Implantation Failure
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls
研究概览
简要总结
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).
详细描述
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).
Primary Objective:
- To compare endometrial thickness and implantation rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy
- To compare ongoing pregnancy and live birth rates in women with AS, AE, and RIF receiving PLERIXAFOR compared to historic controls that received existing standard of care therapy
Secondary Objectives: (assessed in participants who have not achieved pregnancy as of the timepoint):
- Endometrial thickness prior to treatment with PLERIXAFOR compared to endometrial thickness 3 and 6 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Endometrial Disorders
Three groups of patients, with 10 subjects per group:
- 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.
- 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
- 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
干预措施: Plerixafor (Drug)
结局指标
主要结局
Change in endometrial thickness and implantation rates following treatment with Plerixafor at 6 month intervals up to 24 months, compared to controls
时间窗: Every 6 months from baseline up to 24 months
Change in endometrial thickness post treatment compared to historic controls that received existing standard of care therapy, measured using ultrasound. Thicker endometrium (\>6mm) indicates restoration of endometrial function.
次要结局
- Change in endometrial thickness and implantation rates with Plerixafor in women with AS, AE and RIF at 3 month intervals, compared to baseline/pre-treatment(Every 3 months from baseline up to 24 months)
- Change in endometrial thickness from baseline after treatment with Plerixafor at month 3 and month 6 for participants that have not achieved pregnancy as of the timepoint(baseline, month 3 and month 6)
- Difference in ongoing pregnancy and live birth rates in women with AS, AE and RIF following treatment with Plerixafor at 3 month intervals, compared to baseline/pre-treatment(Every 3 months from baseline up to 24 months)
研究者
Hugh Taylor
Chair of Obstetrics, Gynecology and Reproductive Sciences
Yale University