Efficacy of Corifollitropin Alfa in Obese Women in Terms of Clinical and Molecular Parameters of IVF Success
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Fertilized Oocytes
研究概览
简要总结
The aim of the present study is to determine, whether clinical efficacy of 150 mcg of Corifollitropin alfa is the same in normal weighing and obese women. Furthermore, investigators want to determine whether oocytes retrieved from normal weighing and obese women, after COH using 150 mcg of Corifollitropin alfa, are of same quality on the molecular level.
详细描述
The dosage of Corifollitropin alfa used for controlled ovarian hyperstimulation (COH) is adjusted according to the patient's body weight. Meaning, in women with a body weight ≤ 60 kg, a single dose of 100 mcg of Corifollitropin alfa is administered for COH and in women with a body weight > 60 kg, a single dose of 150 micrograms of Corifollitropin alfa is administered for COH. These two protocols are comparable in safety and efficacy of follicular stimulation.
On the other hand, knowledge about the clinical efficacy of 150 mcg of Corifollitropin alfa in obese women (BMI>30 kg/m2) is lacking.
Cumulus cells (CC) surround the oocyte and bi-directional communication between oocyte and CC is necessary for the development of mature and quality oocytes. It has been proposed, that analysis of genes, expressed in CC, can serve as an objective indicator of the oocyte's maturity and developmental potential. Expression of genes in CC as hyaluronan synthase 2 (HAS2), follicle-stimulating hormone receptor (FSHR), versican (VCAN), progesterone receptor (PR), vascular endothelial growth factor C (VEGFC), serine protease inhibitor E2 (SERPINE2), glutathione peroxidase (GPX3), pentraxin 3(PTX3) was reported to correlate with oocyte maturity and developmental potential.
The effect of Corifollitropin alfa on expression of these genes however, is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI > 30 kg/m2
- •BMI 18.5-24.9 kg/m2
排除标准
- •polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years
研究组 & 干预措施
Elonva 150 mcg
Elonva 150 mcg intramuscular daily obese
干预措施: Elonva (Drug)
Elonva 100 mcg
Elonva 100 mcg intramuscular daily normal weight
干预措施: Elonva (Drug)
结局指标
主要结局
Number of Fertilized Oocytes
时间窗: 1 month
Number of Frozen Embryos
时间窗: 1 month
Number of Mature Oocytes
时间窗: 1 month
Number of mature oocytes obtained was compared between groups
Number of Oocytes Retrieved Per Patient
时间窗: 1 month
Number of oocytes obtained in the study group was compared to the number of oocytes obtained in the control group
Biochemical Pregnancy Rate
时间窗: 1 year
次要结局
- Real-time PCR Analysis of Genes That Were Proposed as Biomarkers of Oocyte Quality to Determine Effect of Corifollitropin Alpha on Oocyte Quality on Molecular Level(12 months)
研究者
Tanja Burnik Papler
Principal investigator Tanja Burnik Papler, MD; PhD
University Medical Centre Ljubljana