Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Live birth rate according to stimulation protocol
研究概览
简要总结
A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.
详细描述
A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.
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
- 20 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 20-34 years;
- •body mass index (BMI) 18-29kg/m2;
- •regular menstrual cycle of 26-35 days,
- •AMH levels age appropriate (≥2.3 ng/ml)
- •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 hereditary genetic diseases;
- •women with heart disease, QT prolongation,heart failure
- •elevated liver enzymes, liver failure, hepatitis
- •women with inflammatory or autoimmune disease
- •abnormal karyotype;
- •endometriosis stage III/IV;
- •history of recurrent miscarriage;
- •severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.
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