Repeated Luteal Phase Ovarian Stimulation (Second Step Protocol) in Poor Responder Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of oocyte Retrieved
研究概览
简要总结
Reduced ovarian reserve and the consequent poor ovarian response are very recurent in infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility program may be classified as Poor Ovarian Responder (POR).
Objective: To evaluate whether the repeated luteal phase stimulation (Second Step) permits a significantly higher number of oocytes retrieved in POR when compared to conventional follicular stimulation.
Interventions: The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg).
Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be administered when the leading follicle is ≥ 14 mm until hCG (human chorionic gonadotropin) criteria are met. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.
Two or Three months after the second oocyte retrieval the Embryo transfer (ET) will be performed after endometrial preparation with Estradiol Valerate and intramuscular Progesterone.
详细描述
Reduced ovarian reserve and the consequent poor ovarian response are very recurent in infertile patients, indeed a percentage of 10%-24% of couples addressed to infertility program may be classified as Poor Ovarian Responder (POR).
Poor ovarian response and reduced ovarian reserve can be caused by different factors such as advanced female age, smoking, autoimmune diseases, aneuploidies and genetic diseases or can be idiopathic.
An Eshre ( European Society of Human Reproduction and Embryology) consensus in 2011 established the "Bologna Criteria" that consented a standardize definition of poor ovarian response (POR).
According with the Bologna Criteria we can diagnose a Poor Ovarian Response or an expected Poor Ovarian Response when at least two of the following three features are present:
- Advanced maternal age (≥40 years) or any other risk factor for POR;
- A previous POR (≤3 oocytes with a conventional stimulation protocol);
- An abnormal ovarian reserve test (i.e. AFC -Antral Follicular Count- 5-7 follicles or AMH ,0.5-1.1 ng/ml). The diagnosis and the prediction of poor ovarian response consent the selection of the best treatment with the aim of the retrieval of an high number of oocytes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Antral Follicular Count ≤7 follicles
- •Number of oocyte retrieved with First oocyte retrieval ≤ 2
排除标准
- •Antral follicular Count < 7
- •Anti-Müllerian hormone (AMH) >1.1 ng \mL
- •Number of oocyte retrieved with First oocyte retrieval > 2
- •Absence of antral follicles after First oocyte retrieval
结局指标
主要结局
Number of oocyte Retrieved
时间窗: 15 days after the Second oocyte retrieval
Number of oocyte Retrieved after the first oocyte retrieval vs Number of oocyte Retrieved after the second oocyte retrieval
次要结局
- Number of Embryos Obtained(15 days after the Second oocyte retrieval)
研究者
Antonia Iacovelli
Doctor
Università degli Studi 'G. d'Annunzio' Chieti e Pescara