EVAULATION OF IMPLANTATION AND PREGNANCY AFTER ENDOMETRIAL INJURY VIA ENDOMETRIAL PIPELLE BIOPSY IN THE CYCLE PRIOR TO IVF: A RANDOMIZED, SINGLE-BLINDED, CONTROLLED TRIAL.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 254
- 试验地点
- 2
- 主要终点
- The primary outcome measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.
研究概览
简要总结
This proposed research is a single center, prospective, single-blinded, randomized controlled trial, designed to evaluate IVF pregnancy outcomes following endometrial injury in 254 patients with implantation failure. Patients will be identified during their work-up and treatment at Shady Grove Fertility Reproductive Science Center. Only Shady Grove patients are eligible for the study. The investigators hypothesize in patients with one or more previous failed day 5 blastocyst transfers, injury to the endometrium via endometrial biopsy will improve clinical pregnancy outcomes compared to controls.
详细描述
Despite advances in assisted reproductive technologies; implantation failure in patients undergoing in-vitro fertilization (IVF) is frequent. Unfortunately, few treatments exist except for the use of a gestational carrier. There have been a number of recent clinical studies demonstrating that local injury to the endometrium results in improved clinical pregnancy outcomes for patients with a history of implantation failure. However, not all studies have shown a beneficial effect, and those demonstrating benefit have been limited by small sample sizes, and considerable heterogeneity in the procedures and populations evaluated. A recent meta-analysis synthesized the available data concluded that a large, prospective, well-designed randomized trial is desperately needed to definitively assess this new possible treatment. If these preliminary findings from previous trials are confirmed, this practice could be applied in the clinical setting to help patients suffering from repeated implantation failures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 18-37
- •One or more previous implantation failures with autologous fresh or frozen blastocyst transfer
- •Undergoing fresh autologous IVF cycle
- •No other current uterine (i.e.: uterine fibroids, polyps), hematologic, or genetic causes for infertility and implantation failure
- •One or more good quality blastocyst(s) available for transfer
排除标准
- •Those unable to comprehend the investigational nature of the proposed study
- •Positive pregnancy test
- •Possible causes for impaired implantation (systemic disease, endometriosis, ultrasound evidence of current hydrosalpinx, uterine polyps, uterine myomas (fibroids), uterine cavity malformations or Asherman's syndrome)
- •Poor responders, defined as FSH >12 on day 3 or less than 4 follicles on a previous IVF cycle
- •BMI >30 or <18
结局指标
主要结局
The primary outcome measurement in this study is clinical pregnancy rate, which is defined as identification of a fetal heart beat on ultrasound.
时间窗: 8-10 weeks after embryo transfer
次要结局
- miscarriage rate(2 years)
- implantation rate(8-10 weeks after embryo transfer)
- multiple gestation rate(at delivery)
- endometrial thickness during stimulation(during stimulation)
- Live Birth rate(10 months after IVF cycle)
研究者
Ryan Heitmann
REI Clinical Fellow
Shady Grove Fertility Reproductive Science Center