NCT04487925招募中4 期
A Randomized Comparison of One Controlled Ovarian Stimulation With Corifollitropin Alfa Versus up to Three Modified Natural Cycles in Expected and Established Poor Responders
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Number of good quality blastocysts after CFA stimulation vs. after a first MNC
研究概览
简要总结
This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).
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
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed consent form (ICF) dated and signed.
- •Age ≥18 and <45 years old.
- •Body Mass Index (BMI) ≥18.5 Kg/m² and <35 Kg/m².
- •Regular menstrual cycles (between 21 and 35 days).
- •Two ovaries present.
- •Current pregnancy wish.
- •Poor responders as defined according to the POSEIDON criteria:
- •POSEIDON Group 3: patients < 35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC <5 or AMH <1.2 ng/mL).
排除标准
- •Simultaneous participation in another clinical study.
- •Untreated and uncontrolled thyroid dysfunction.
- •Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
- •Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- •Ovarian cysts or enlarged ovaries.
- •Malformations of the reproductive organs.
- •Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
- •Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
- •Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.
研究组 & 干预措施
Up to 3 modified natural cycles
Active Comparator
干预措施: Up to three modified natural cycles with Follitropin beta. (Drug)
Controlled ovarian stimulation
Experimental
干预措施: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation (Drug)
结局指标
主要结局
Number of good quality blastocysts after CFA stimulation vs. after a first MNC
时间窗: On fifth day of embryonal development
次要结局
- Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC(On fifth day of embryonal development)
- The relative number of blastocysts after ART, relative to the number of oocytes(On fifth day of embryonal development)
- The probability of having at least one blastocyst of good quality after ART(On fifth day of embryonal development)
研究者
研究点 (1)
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