Impact of Cytokine Supplementation With Various Protein Concentrations Into Human in Vitro Culture Medium on ICSI Cycle Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 3
- 主要终点
- live birth rate
研究概览
简要总结
A randomized clinical trial to evaluate the effect of cytokine supplementation in embryo culture medium with various protein concentrations aiming to evaluate the effects of cytokines (CYK) integration into the human in vitro culture medium with high and low human serum albumin (HSA) concentrations on live birth rates after intracytoplasmic sperm injection (ICSI).
详细描述
Oocytes were injected, and embryos cultured and transferred in three supplemented culture media.
A- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, without supplementation of CYK (control n=200), B- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, with 2ng/mL GM-CSF (granulocyte macrophage colony stimulating factor) (G5035 Sigma), 5ng/mL HB-EGF (Heparine Binding Epidermal Growth Factor )(E4643 Sigma),and 5ng/mL LIF (Lukemia Inhbitory Factor) (SRP9001 Sigma)(n=200).
C- A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global protein, with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF (SRP9001 Sigma).(n=200) Setting :- - Mansoura Integrated Fertility
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who fitted the medical definition of infertility "One year of unprotected intercourse but not pregnant".
排除标准
- •History of ovarian or adnexal surgery.
- •Suspicious findings of ovarian malignancy.
- •Presence of endocrine disorders such as diabetes mellitus, hyper-prolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing's syndrome, and adrenal insufficiency.
- •Presence of Globozoospermia (100% round-headed spermatozoa)
结局指标
主要结局
live birth rate
时间窗: 9 months
the number of deliveries that resulted in at least one live born baby (\>20 weeks gestational age or 500 gm birth weight ) expressed per 100 embryo transfer,
次要结局
- Top quality day 3 embryos(4 weeks)
- Implantation rate(8 weeks)
- Early embryo loss rat(16 weeks)
- Fertilization rate(4 weeks)
- Blastocyst formation rate(4 weeks)
- Top blastocyst rate(4 weeks)
- Available embryo rate(4 weeks)
- clinical pregnancy rate(8 weeks)
- ongoing pregnancy rate(16 weeks)
- Biochemical pregnancy rate(6 weeks)
研究者
Emad Mohamad Sedeek
Senior embryologist in IVF laboratory,
Mansoura Integrated Fertility Center