A Phase IV, Open-label 2 Arm Trial to Compare the Efficacy and Safety of a Pre-defined Dose of GONAL-f® Based on Antral Follicle Count [Follicles ≥2mm - <11mm]), or AMH for Ovarian Stimulation in Subjects Undergoing Assisted Reproductive Technology (ART) Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 348
- 试验地点
- 1
- 主要终点
- Number of oocytes retrieved
研究概览
简要总结
The overall objectives of this trial are to:
- To explore the efficacy and safety of using either antral follicle count (AFC) or anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian stimulation for Assisted Reproductive Technology (ART).
- To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART.
详细描述
Trial design
This trial is a prospective, Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f® dose for the stimulation treatment of subjects undergoing ART.
Throughout the trial period and before the start of a routine ART cycle, investigators will propose the trial to their potential subjects. All subjects who agree to participate in the trial must sign a consent form, irrespective of whether or not they ultimately agree to have their dose determined by the study protocol. Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm (control) or the AMH guided arm (treatment). The starting doses of GONAL-f® for each arm will be based on the study algorithms, using AFC or AMH guidance.
The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f® dose for that specific subject. This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the site's routine clinical practice.
Trial Population
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Starting a treatment with GONAL-f® according to the decision of the investigator and in accordance with the indication and dosing recommendation
- •Age < 40 years at the time of GONAL-f® dosing
- •BMI < 28 kg/m2
- •An early follicular phase (Day 2-4) serum levels of basal FSH ≤12 IU/L measured in the site's own laboratory and taken within 2 months prior to down-regulation start
- •Receiving long Gonadotropin-Releasing Hormone (GnRH) agonist protocol (starting on day 21 of preceding cycle until day of hCG)
- •Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- •Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
排除标准
- •Simultaneous participation in an interventional clinical trial.
- •Concommitant use of either Luteinizing Hormone or human menopausal gonadotropin/urinary FSH preparations in study cycle
研究组 & 干预措施
Antral follicle count
Start dose of recombinant Follicle-Stimulating Hormone (rFSH) based on AFC guide
- AFC < 6 on both ovary: 375 IU FSH
- 6<AFC <=15 on both ovary: 225 IU FSH
- AFC> 15 on both ovary: 150 IU FSH
干预措施: FSH (Drug)
Anti-Mullerian Hormone
Start dose of FSH based on AMH guide
- AMH < 5 pmol/L or < 0.7ng/ml: 375 IU FSH
- AMH 5 to < 15 pmol/L or 0.7 to 2.1ng/ml: 225 IU FSH
- AMH ≥ 15 pmol/L or > 2.1ng/ml: 150 IU FSH
干预措施: FSH (Drug)
结局指标
主要结局
Number of oocytes retrieved
时间窗: 30 minutes after oocyte retrieval completed
次要结局
- Symptoms of ovarian hyperstimulation syndrome (OHSS)(in 10 days after hCG injection)
研究者
Manh Tuong Ho
Dr
Vietnam National University