EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Livebirth >20 weeks
研究概览
简要总结
EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to this difficult group of patients.
Results showed a highly significant effect of 44% relative improvement in ongoing implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).
We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media improves pregnancy outcomes in women with recurrent implantation failure, recurrent miscarriage and poor embryo development when compared to standard media.
详细描述
A randomised control pilot study will be undertaken for 100 women who have implantation failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are having a further IVF cycle.
At oocyte retrieval each couple will be randomised using numbered envelopes containing pre randomised group allocations by a person uninvolved in the trial to:
- BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media) for remaining 2 days or
- Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium for 5 days.
The best single embryo will be transferred on day 5.
The clinical staff and participating couple will be blinded as to whether BlastGen or standard media was used in culture to day 5. Fertility SA embryologists will not be blind as to which study group a couple is in and which media is being used. The embryos will be cultured using the usual methods and lab facilities by Fertility SA's current embryology staff members who will not be blind to the media being used.
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
- 25 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women undertaking an IVF or ICSI cycle
- •aged between 25 and 41 years
- •2 or more embryos transferred without a positive pregnancy outcome OR a history of at least 1 previous pregnancy loss, OR
- •Poor embryo development (<20% of embryo developing on time at Day 3 or no blastocyst above Grade 2 on Day 5)
排除标准
- •male partner requiring surgical retrieval of sperm except in cases of previous vasectomy
- •the use of another investigational drug within 30 days
- •any severe chronic disease that would significantly influence an IVF cycle
- •less than 3 follicles>14mm on ultrasound on the day of HCG trigger
研究组 & 干预措施
EmbryoGen/BlastGen
EmbryoGen and BlasGen media containing GM-CSF 2ng/ml will be used in the experimental arm
The intervention is to use EmbryoGen/BlastGen
干预措施: EmbryoGen/ BlastGen media (Device)
Control
Standard Cook sequential media
干预措施: Standard Cook sequential media (Device)
结局指标
主要结局
Livebirth >20 weeks
时间窗: 9 months after closure of trial (18 +9 months)
Any delivery \>20 resulting in a livebirth
次要结局
- Cryopreservation outcomes(18 months)
- Congenital Anomaly Rate(9 months after closure of trial (18 +9 months))
- Number of embryos reaching blastocyst stage(18 months)
- Clinical pregnancy rates at 7 and 12 weeks gestation(18 months)
- Day 3 and day 5 embryo scores(18 months)