Evaluating Cytokine Concentrations in the Endometrium Before and After Autologous Platelet Rich Plasma Uterine Infusion Preceding Frozen Embryo Transfer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determine the effect of autologous uterine PRP infusion on factors critical to the implantation process
研究概览
简要总结
Platelet Rich Plasma (PRP), a rich source of important growth factors, has been shown to significantly affect the body's ability to heal and regenerate tissues. It is an affordable, accessible treatment with little risk of side effects that is being utilized in many areas of regenerative and cosmetic medicine. PRP is also relatively easy to prepare with supplies on hand in most IVF clinics. Specifically relating to reproductive function, PRP has been demonstrated to increase cellular proliferation and decrease fibrosis in damaged rat endometrium. It is hypothesized that infusing the uterus with Platelet Rich Plasma at measured intervals prior to embryo transfer will increase concentrations of implantation-promoting cytokines while reducing concentrations of inflammatory cytokines during the window of implantation.
详细描述
- Platelet Rich Plasma (PRP), a rich source of important growth factors, has been shown to significantly affect the body's ability to heal and regenerate tissues.7 It is an affordable, accessible treatment with little risk of side effects that is being utilized in many areas of regenerative and cosmetic medicine. PRP is also relatively easy to prepare with supplies on hand in most IVF clinics. PRP has shown great promise in veterinary medicine to regenerate tissues and reduce endometrial inflammation.8 Specifically relating to reproductive function, PRP has been demonstrated to increase cellular proliferation and decrease fibrosis in damaged rat endometrium.6 Endometritis, which is characterized by an increase in inflammatory cells, erosion of the endometrial epithelial layer as well as endometrial edema has been a large cause of infertility in cattle and therefore revenue loss in the cattle industry. A recent study applying uterine infusion of PRP as the intervention demonstrated decreased markers for inflammation in cattle in vivo and as well as decreased inflammatory markers in in vitro cultured endometrial cells exposed to PRP.6 A similar in vitro study was conducted on horses; the authors noticed a decrease in clinical uterine infections in mares along with an increased embryo recovery rate.31 Chronic endometritis is hypothesized to be one of the potential factors involved in recurrent implantation failure in women.32 Using these previous studies in veterinary medicine as a model for potential benefit in human patients, it would be prudent to explore the mechanism of PRP action in humans. It is hypothesized that infusing the uterus with Platelet Rich Plasma at measured intervals prior to embryo transfer will increase concentrations of implantation-promoting cytokines while reducing concentrations of inflammatory cytokines during the window of implantation. TGF-b, IL-6 and LIF are known to be promoters of implantation, while TNF-a and IL-4 are pro-inflammatory factors and can inhibit implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
- It is not possible to blind clinical staff for the procedure. It is not necessary for the integrity of the study to blind participants as we are assessing their pregnancy outcomes. Regardless of which group they are assigned, participants will partake in routine prenatal care, as well as two additional study visits. They will know which group they have been assigned at the time of the procedure based on if they receive the treatment prior to implantation or not.
入排标准
- 年龄范围
- 23 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient at REI clinic population
- •Ages 23 to 45
- •Undergo frozen embryo transfers with clinic standard medicated protocols
- •Transferring one or two embryos on day 5 or 6 of development
排除标准
- •Low level or high-level mosaic
- •Aneuploid embryos only will be excluded
- •Desiring day 3 or fresh embryo
研究组 & 干预措施
PRP Experimental
The treatment group will receive 1 ml of autologous PRP infused into the cervix via Rocket IUI catheter at 72+/- 5 hours and 48 +/- 5 hours prior to embryo transfer. Prior to the first PRP infusion, endometrial secretions will be aspirated as described in a previous study regarding endometrial secretions. An embryo transfer catheter will be introduced trans-cervically. A 2 mL syringe will be used to gradually add suction, aspirating secretions from the endometrium. The outer sheath of the embryo catheter will be positioned in the exterior, and the inner catheter retracted into the outer sheath, to avoid cervical fluid contamination in the collected endometrial secretions. Secretions will be deposited into screw top cryovials by snipping the end of the transfer catheter containing secretion off into the tube. These tubes will then be snap-frozen in liquid nitrogen. Process will be repeated prior to embryo transfer
干预措施: PRP Experimental (Biological)
PRP Control
Negative control patients will have endometrial secretions aspirated at identical intervals to the test group but will not receive PRP infusions.
干预措施: PRP Experimental (Biological)
结局指标
主要结局
Determine the effect of autologous uterine PRP infusion on factors critical to the implantation process
时间窗: 18 months
Compare differences of the levels TGF- b, IL-6 and LIF in endometrial secretions pre- and post-treatment.
次要结局
- Determine the effect of autologous uterine PRP infusions on factors that are deleterious to embryo implantation(18 months)