Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Blastulation Rate
研究概览
简要总结
The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.
详细描述
The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females age < 42 with an indication for IVF
- •Females with lowest AMH level 1.2 ng/mL or higher
- •Females with FSH < 13 mIU/mL
- •Sperm obtained via Surgical retrieval (any type) for IVF only
- •Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy
- •BMI < 35
- •Baseline antral follicle count of > 8
- •Single embryo transfers only
排除标准
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
- •Contraindication to IVF
- •Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis)
- •Fewer than 4 mature oocytes retrieved (will not randomize)
- •Male partner with non-obstructive azoospermia
- •Male partner with any Karyotype other than 46,XY
- •Male partner with history of spinal cord injury
- •Male partner with Kallman's syndrome
- •History of chronic oligomenorrhea
- •History of hydrosalpinges or adnexal mass
- •History of endometrial insufficiency (max endometrial thickness < 7mm)
研究组 & 干预措施
Fresh surgical testicular sperm
Fresh, surgically obtained testicular sperm
Frozen surgical testicular sperm
Surgically obtained testicular sperm that will undergo slow freezing and thawing
干预措施: Slow Freezing and Thawing (Other)
结局指标
主要结局
Blastulation Rate
时间窗: 5-7 days post ICSI procedure
total number of embryos reaching the blastulation stage of development
次要结局
- Fertilization Rate(1 day post ICSI)
- Time to Find Sperm in Fresh Specimen(up to 6 hours post surgery)
- Post-thaw recovery rate of frozen surgical sperm(30 minutes after freezing)
- Aneuploidy Rate(2 weeks post trophectoderm biopsy)
- Implantation Rate(approximately 4-6 weeks post embryo transfer)