Comparison of Cumulative Live Birth Rate Per Initial Cycle Between 300 IU and 150IU Starting Dose of rFSH Among Aged Patients With Poor Ovarian Reservation: a Randomized Controlled Trail
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Cumulative live birth rate
研究概览
简要总结
Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（AFC）≤ 5 or anti-mullerian hormone（AMH）≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone（GnRH）antagonist protocol. This study is a prospective randomized controlled trial.
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
- 35 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age Limits≥35 and≤42；
- •AFC≤5 or AMH≤1.2ng/ml；
- •BMI≤30kg/m2；
- •The first IVF/intracytoplasmic sperm injection （ICSI） cycle；
排除标准
- •Any other underlying disease or condition considered IVF is contraindicated.
- •Ovarian hyperstimulation syndrome（PCOS）, moderate or severe intrauterine adhesion，untreated hydrosalpinx, adenomyosis， any myoma in cases that endometrium was affected, intramural larger than 4cm.
- •Autoimmune antibody positive, untreated.
- •History of recurrent miscarriages.
- •Patients seeking for Preimplantation Genetic Testing(PGT) treatment.
- •Simultaneous participation in another clinical study.
- •According to the judgment of the investigator, any reason or condition that precludes subject for participating in the study.
研究组 & 干预措施
300IU rFSH stimulation group
300IU rFSH stimulation group is defined as patients using gonadotropin-releasing hormone（GnRH）antagonist protocol with a 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation.
干预措施: 300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation (Drug)
150IU rFSH stimulation group
150IU rFSH Gonal-F® stimulation group is defined as patients using GnRH antagonist protocol with a 150IU rFSH starting dose during controlled ovarian stimulation.
干预措施: 150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation (Drug)
结局指标
主要结局
Cumulative live birth rate
时间窗: 22 months
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions。And cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
次要结局
- Multiple pregnancy rate(22 months)
- Time to live birth(22 months)
- Cycle cancellation rate(1 month)
- Number of MII eggs(1 month)
- Cumulative Clinic pregnancy rate(14 months)
- cumulative pregnancy loss rate(19 months)
- Implantation rate(14 months)
- Neonatal malformation rate(22 months)
- Good quality embryo rate(1 month)
- Birth weight(22 months)