2023-509094-23-00招募中4 期
A randomized comparison of one controlled ovarian stimulation with corifollitropin alfa (CFA) versus up to three modified natural cycles (MNC) in expected and established poor responders
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).
研究概览
简要总结
to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a first MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Good quality is defined by the Gardner score 5AA, 5AB or 5BA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Two Strategies For The Management Of Predicted Low Prognosis Patients Under Stimulation For Ivf/icsi
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4: • 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*) * AMH value should not be older than 12 months.
- •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
- •Single embryo transfer (SET)
排除标准
- •Basal FSH > 20 IU/L in the last 12 months
- •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
- •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
结局指标
主要结局
the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).
the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).
次要结局
- the relative number of blastocyts after ART (on the day of embryo transfer), relative to the number of oocytes (rate)
- the probability of having at least one blastocyst of good quality after ART (on the day of embryo transfer) (binary endpoint)
- the probability of having an ongoing pregnancy which is defined as 6 to 8 weeks gestational age (binary endpoint) o Related sensitivity endpoint:, as confirmed by ultrasound (time to event)
研究者
Wijnant Kathleen
Scientific
Universitair Ziekenhuis Gent
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A randomized comparison of one controlled ovarian stimulation with corifollitropin alfa (CFA) versus up to three modified natural cycles (MNC) in expected and established poor respondersSubfertilityCTIS2023-509094-23-00niversitair Ziekenhuis Gent300
进行中（未招募）
1 期
Controlled ovarian stimulation with highly purified menotropin in low-responder patients.EUCTR2016-001590-32-ESManuel Macía Cortiñas64
Unknown
4 期
to look for the improvement after Using of Chlorhexidine Chip in treatment of Chronic PeriodontitisCTRI/2019/07/020123Dr Pramila kumari koirala
已完成
不适用
A randomized controlled trial comparing an S-O clip and a clip with line traction method of endoscopic submucosal dissection for gastric epithelial neoplasiaearly gastric cancer, gastric adenomaJPRN-UMIN000041385Department of Endoscopy, Shonan Fujisawa Tokushukai Hospital106
招募中
4 期
controlled study between erector spinea plane block versus paravertebral nerve block in neonates undergoing tracheo-esophageal fistula repairNeonatal DiseasesAnaesthesiaPACTR201908568919626Faculty of Medicine40