Impact of Hyaluronan-enriched Medium on Pregnancy Outcomes Following Euploid Blastocyst Transfers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 783
- 试验地点
- 2
- 主要终点
- Live birth rate (LBR)
研究概览
简要总结
It has been proposed that enriching transfer media with hyaluronan (EmbryoGlue medium) improves pregnancy outcomes compared with media containing lower concentrations of this molecule. However, none of previous studies included preimplantation genetic testing for aneuploidy (PGT-A) embryos. In order to investigate the impact of this hyaluronan-enriched on pregnancy outcomes, it is essential to evaluate its efficacy on euploid-only embryo transfers. The aim of the present study is to evaluate whether a short period of exposure of euploid blastocysts to EmbryoGlue prior to and during transfer positively impact on pregnancy outcomes of frozen embryo transfer (FET) cycles.
详细描述
The study period will be determined by the completion of the predetermined sample size, with two interim analyses planned when 35% (n=274) and 70% (n=548) of the target sample size is achieved to calculate conditional power. If conditional power is estimated to be lower than 15% at first interim analysis or lower than 30% in the second interim analysis, the trial will be stopped due to futility. The study will be performed in Abu Dhabi-Fertility clinic. During the period of this prospective study, euploid blastocysts of enough quality that have been biopsied only on Day-5 for PGT-A, will be warmed for single blastocyst transfer. The patient´s endometrial preparation protocol for FET will be restricted to HRT only. The study will be double-blinded (blinded to patient and doctor performing transfer).
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
- Double (Participant, Care Provider)
盲法说明
The study will be double-blinded (blinded to patient and doctor performing transfer).
入排标准
- 年龄范围
- 18 Years 至 46 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All frozen embryo transfer (FET) cycles with euploid blastocysts biopsied and vitrified on Day 5 after PGT-A.
- •Rank of randomization based on embryo quality.
- •Only hormonal replacement theraphy (HRT) cycle regimen.
- •Women aged 18 years to 46 years.
- •Having at least 1 chromosomally normal vitrified blastocyst(s) on Day 5 available for transfer.
- •All sperm samples.
- •BMI between 18 and 35.
排除标准
- •FET cycles with preimplantation genetic testing for monogenic disorders (PGT-M) and for structural rearrangements (PGT-SR).
- •FET cycles with mosaic / aneuploid blastocysts.
- •FET cycles with unknown outcome.
- •FET cycles with Day 6 or Day 7 biopsied blastocysts.
- •FET with patients' endometrium preparation with treatments other than HRT.
- •FET where PGT-A was performed for gender selection.
研究组 & 干预措施
Blastocysts exposed to EmbryoGlue (EG)
Blastocysts exposed to EmbryoGlue
干预措施: EmbryoGlue Medium (Drug)
结局指标
主要结局
Live birth rate (LBR)
时间窗: 41 weeks
Defined as the delivery if a live infant born after 24 completed weeks of gestation
次要结局
- Clinical pregnancy rate(6 weeks)
- human chorionic gonadotropin (hCG) positiveness(10-12 days after embryo transfer)
- Clinical miscarriage rate(24 weeks)
- Ongoing pregnancy rate after 12 weeks(13 weeks)
研究者
Daniela Nogueira
Global Scientific Laboratory Director ART Fertility Clinics
ART Fertility Clinics LLC