In Vitro Maturation Versus Standard in Vitro Fertilization in Infertile Patients Diagnosed With Polycystic Ovaries Syndrome: a Study Protocol for a Single-center Prospective, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- the proportion of ongoing pregnancy leading to live birth
研究概览
简要总结
A single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among infertility couples with PCOS in China.
详细描述
A single center, randomized controlled clinical trial will enroll 350 couples with PCOS undergoing their first cycle of IVF. The participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. On day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- IVM protocol, and standard IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile couples scheduled for their first IVF cycle.
- •Women diagonosed with polycystic ovarian syndrome.
- •Voluntary participation and informed consent obtained.
排除标准
- •Couple with contraindication for IVF or ICSI.
- •Couples receiving donor sperm or donor eggs.
- •Couples with indications or have plan to receive PGD and PGS.
- •Sperm analysis diagnosed as azoospermia;
- •Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
- •Women who have undergone unilateral ovariectomy.
研究组 & 干预措施
standard IVF
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group A will receive standard IVF procedure. Other standard assisted reproductive treatments are similar and parallel between two groups.
干预措施: standard IVF (Procedure)
In vitro maturation
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group B will receive IVM procedure.Other standard assisted reproductive treatments are similar and parallel between two groups.
干预措施: In vitro maturation (Drug)
结局指标
主要结局
the proportion of ongoing pregnancy leading to live birth
时间窗: after 22 weeks of gestation
number of ongoing pregnancy leading to live birth resulting from the first oocyte retrieval cycle after the randomization ( 6 month) divided by the number of patients with oocyte retrieval
次要结局
- Miscarriage(28 weeks of gestation)
- Preterm birth(28-37 weeks of pregnancy)
- Birth weight(within 2 weeks after live birth)
- Moderate/severe ovarian hyperstimulation syndrome (OHSS)(From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.)
- implantation(28 days after embryo transfer)
- Small for gestational age(within 2 weeks after live birth)
- Congenital anomaly(within 2 weeks after live birth)
- Perinatal mortality(within 2 weeks after live birth)
- clinical pregnancy(7 weeks after embryo transfer)
- Large for gestational age(within 2 weeks after live birth)
研究者
Jie Qiao
President
Peking University Third Hospital