G-CSF and Endometrial Growth, Embryo Implantation and Pregnancy Following FET or Donor ET
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Endometrial Thickness
研究概览
简要总结
The purpose of this study is to investigate the effect of G-CSF on endometrial thickness in women who have failed reaching minimal endometrial thickness by standard treatments, to assess how many reach embryo transfer and what implantation and pregnancy rates are in comparison to control patients. The study will be conducted in women undergoing transfer of previously cryopreserved embryos or undergoing transfer of embryos from donor eggs.
详细描述
Objective: To investigate the effect of treatment with CSF : A placebo controlled double blinded crossover study.
Design: Crossover Randomized Control Trial
Setting: Academically affiliated private infertility centers
Subjects: Female IVF patients of all ages who are willing to be randomized to treatment and, in either IVF treatment, frozen embryo cycles (FET) or donor IVF cycles (D-IVF), 5 days before ET, have inadequate endometrial thickness.
Interventions: Subjects receive transvaginally, utilizing an insemination catheter, 2 slow intrauterine lavages with CSF-1 (Neupogen or generic, 300ug in 1 ml) 5 and 3 days, respectively, before embryo transfer and controls receive 1 ml of saline instead. Patients who do not become pregnant will after one month washout times continue treatment in the opposite study arm if they so choose and if they have remaining embryos.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient's preparing for invitro fertilization and embryo transfer with endometrial growth of less than 7 mm, unresponsive to standard treatment
排除标准
- •Sickle Cell disease
- •Renal insufficiency
- •Upper respiratory infection or Pneumonia
- •Chronic Neutropenia
- •Known Past or present malignancy
研究组 & 干预措施
G-CSF
G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
干预措施: G-CSF (Drug)
Saline
Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
干预措施: Saline (Drug)
结局指标
主要结局
Endometrial Thickness
时间窗: Day of embryo transfer
Thickness of the endometrium on the day of embryo transfer
次要结局
- Implantation Rate(28 days after embryo transfer)
研究者
David H. Barad
Director of Clinical Research
Center for Human Reproduction