2024-517312-30-00招募中4 期
Effect of recombinant FSH dosing following corifollitropin alfa in patients undergoing IVF/ICSI in a GnRH antagonist protocol: a randomized controlled dose-finding study.
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- UZ Brussel
- 入组人数
- 261
- 试验地点
- 3
- 主要终点
- Mean serum P level on trigger day
研究概览
简要总结
Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.
研究设计
- 研究类型
- Interventional
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
- •Female age: > 18 to < 40 years
- •No hormonal pre-treatment within the month before the start of the treating cycle
- •Signed informed consent
- •The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these at-tempts)
- •BMI ≤29 Kg /m2
- •Patients of ≤ 36 years old, body weight should be >60kg
- •Patients of >36 years old, body weight should be > 50 kg
- •Regular normo-ovulatory menstrual cycles (26–35 days)
- •Basal FSH <10 IU/l, basal E2 <60 pg/ml and basal Progesteone (< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
- •Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
- •AFC >7 and < 20
排除标准
- •Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification(2018)
- •Oocyte donors
- •Poor responder patients (defined by the Bologna criteria (Ferraretti et al., 2011): eligible women had to fulfil at least two of the three following criteria: (i) advanced maternal age (≥40 years) or any other risk factor for poor ovarian response (patients with genetic or ac-quired conditions); (ii) poor ovarian response (≤3 oocytes with a conventional stimulation protocol); (iii) abnormal ovarian reserve test (antral follicle count [AFC] <7 or anti-Müllerian hormone [AMH] <1.1 ng/ml). follow up)
- •Endometriosis ≥ grade 3
- •Contraindications to the use of gonadotropins
- •Abnormal vaginal bleeding of unknown cause
- •History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteristics)
- •A history of recurrent miscarriage (three or more consecutive miscarriages)
- •Surgical obtained sperm (TESE and FNA)
结局指标
主要结局
Mean serum P level on trigger day
Mean serum P level on trigger day
次要结局
- Number of COCs retrieved
- Number of patients who underwent FA
- Clinical pregnancy rate
- Ongoing pregnancy rate
- Miscarriage rate
- Live birth rate
研究者
Prof. Dr. Christophe Blockeel
Scientific
UZ Brussel
研究点 (3)
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