Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Efficacy (Maturation index)
研究概览
简要总结
GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles
详细描述
Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients should be candidates for ICSI.
- •Age between 20-40 years.
- •Body mass index 18-35 kg/m
- •Diagnosis of PCOS according to modified Rotterdam's criteria
排除标准
- •Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
研究组 & 干预措施
Group (A)
will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
干预措施: progestin primed ovarian stimulation protocol (Other)
Group (A)
will be subjected to progestin primed ovarian stimulation protocol Women in group (A), will be prescribed 20 mg oral dose of dydrogesterone (Duphaston, Abbott) from the 2nd day of the cycle and continued until the trigger day. Transvaginal follicular monitoring will be done for all patients starting the 6th day of cycle.
干预措施: dydrogesterone (Duphaston, Abbott) (Drug)
group (B)
Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.
干预措施: progestin primed ovarian stimulation protocol (Other)
group (B)
Gonadotropin Releasing Hormone Antagonist Protocol when the size of dominant follicles reaches 12-13 mm, 0.25 mg of cetrotide (Merck-Serono Germany) will be injected subcutaneously daily and continued until the day of trigger shot.
干预措施: Cetrotide (Drug)
结局指标
主要结局
Efficacy (Maturation index)
时间窗: 3 months
Maturation index will be calculated: Rate of metaphase-II oocytes (MII) to total oocytes
Efficacy (Number of MII oocytes retrieved)
时间窗: 3 months
this outcome means to measure Percentage (number) of MII oocytes retrieved During our study
次要结局
未报告次要终点