The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Blastulation Rate per Mature Oocyte (M2)
研究概览
简要总结
This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.
详细描述
In this study, we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI, while also accounting for paternal age. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI. Embryology parameters, ploidy status, DNA fragmentation and clinical pregnancy outcomes will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 18 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing first IVF cycle
- •Electing single embryo transfer
- •Electing PGT-A of their embryos
- •Female partners age <42 years old at start of VOR cycle, but >18 years old.
- •AMH ≥ 1.2 ng/mL
- •FSH ≤ 12IU/L
- •At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
- •Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
排除标准
- •Contraindication to IVF
- •Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
- •Male partner with azoospermia or oligozoospermia (<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)
- •Planned for previously cryopreserved sperm to be used for ICSI
- •Donor sperm
- •Male partner with Y-chromosome microdeletion
- •Male partner with any Karyotype other than 46,XY
- •Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
- •Uncorrected hydrosalpinges that communicate with the endometrial cavity
- •Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
- •Donor oocyte or embryo cycles
- •Gestational carriers
研究组 & 干预措施
Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device
Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.
干预措施: Microfluidic sperm separation device (Device)
Oocytes inseminated by sperm prepared via density grade centrifugation
The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.
干预措施: Density grade centrifugation (Other)
结局指标
主要结局
Blastulation Rate per Mature Oocyte (M2)
时间窗: approximately 1 week post oocyte retrieval procedure
count of blastocyst stage embryos per M2 count
次要结局
- Fertilization Rate(approximately 24 hours post oocyte retrieval procedure)
- Blastulation Rate per 2PN(approximately 1 week post oocyte retrieval procedure)
- Blastocyst Morphology using Modified Gardner Scale(approximately 1 week post oocyte retrieval procedure)
- Ploidy rates(approximately 2 weeks post blastocyst trophectoderm biopsy)
- Ongoing pregnancy rate(6 weeks post embryo transfer)
- Pregnancy Loss Rates(1 day to 7 months post positive beta human chorionic gonadotrophin)
- Live birth rate(approximately 7 months after discharge to obstetrician)
- Sperm DNA Fragmentation(approximately 1-3 hours post intracytoplasmic sperm injection procedure)
- Positive beta human chorionic gonadotrophin (bhcg)(7-10 days post embryo transfer)
- Embryological Efficiency(same day as ICSI procedure)
- Embryology Questionnaire(upon primary outcome completion in approximately 18 months)