A New Revolutionary 3-Injection- Protocol in Infertile Women With a Single Long Acting GnRH Antagonist in the Luteal Phase, a Bolus Gonadotropin Injection in the Early Follicular Phase and a Single Triggering Dose.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Live birth rate according to stimulation protocol
研究概览
简要总结
This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.
详细描述
A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.
Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).
Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.
Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •primary infertility
- •age 22-39 years;
- •body mass index (BMI) 18-29kg/m2;
- •regular menstrual cycle of 26-35 days,
- •presumed to be ovulatory;
- •early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).
排除标准
- •women with diabetes and other metabolic disease
- •women with heart disease, QT prolongation, heart failure
- •elevated liver enzymes, liver failure, hepatitis
- •women with inflammatory or autoimmune disease
- •abnormal karyotype
- •polycystic ovarian syndrome
- •endometriosis stage III/IV
结局指标
主要结局
Live birth rate according to stimulation protocol
时间窗: Up to 38 weeks after embryo transfer
Live birth rate according to stimulation protocol
次要结局
- Blastulation rate according to stimulation protocol(Up to 6 days post oocyte retrieval)
研究者
Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic
Assisting Nature