Reduction of Progesterone Elevation at Trigger in Poor Responder Bologna' Criteria Patients After Controlled Ovarian Stimulation With Long Acting Standard Stimulation Protocol Compared With Conventional Daily Protocol: a Single Center Prospective Randomized Fase IV Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Premature progesterone elevation
研究概览
简要总结
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
详细描述
Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.
The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.
Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.
The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Indication to IVF treatment
- •Normal BMI (18.5-24.9 kg/m2)
- •AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
- •Regular menstrual cycles
- •Signed informed consent
排除标准
- •Freeze all cycles for abnormal bleeding
- •History of untreated autoimmune
- •Endocrine or metabolic disorders
- •Ovarian cystectomy or oophorectomy
- •FSH ≥ 20 lU/L
研究组 & 干预措施
Corifollitropin alpha group
Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation
干预措施: Corifollitropin alfa (Drug)
Corifollitropin alpha group
Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation
干预措施: Follitropin Beta (Drug)
FSH group
Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol
干预措施: Follitropin Beta (Drug)
结局指标
主要结局
Premature progesterone elevation
时间窗: day 12
Progesterone \> or equal to 1.1 ng/mL at day of trigger
次要结局
- Number of oocytes collected at ovum retrieval(day 14)
- Fertilization rate(day 15)
- Percentage of freeze-all cycles due to premature progesterone elevation(day 12)
- Pregnancy rate(day 30)
- Number of embryos available(Day 17)
- Ongoing pregnancy(Up to 20 weeks)
