NCT05227391Unknown不适用
Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
Reproductive & Genetic Hospital of CITIC-Xiangya1 个研究点 分布在 1 个国家目标入组 1,078 人开始时间: 2022年3月16日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,078
- 试验地点
- 1
- 主要终点
- Live birth rate
研究概览
简要总结
This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.
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
- •1. women diagnosed with PCOS according to modified Rotterdam criteria;
- •2. Women who are participating in their first cycle of IVF or ICSI.
- •3. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
- •4. Women with whole embryos freezing.
- •5. Women aged 20 to 38 years old;
- •6. Women BMI 18 kg/m2 to 30 kg/m2
- •7. Women with at least one good-quality embryo suitable for transfer, including day 3 cleavage stage embryo with grade 7CI /8CI and day 5 or day 6 blastocyst with grade 4BB or higher.
排除标准
- •1. Women who has a history of recurrent spontaneous abortion.
- •2. Women with unilateral/bilateral oophorectomy.
- •3. Women with untreated Hydrosalpinx.
- •4. Women with a uterine cavity abnormality, such as a uterine congenital malformation, untreated uterine septum (except shallow uterine septum), adenomyosis, submucous myoma, or moderate to severe intrauterine adhesions.
- •5. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
- •6. Women who are indicated and planned to undergo preimplantation genetic test (PGT).
研究组 & 干预措施
Letrozole-stimulated group
Experimental
干预措施: Oral Letrozole (Procedure)
Hormone replacement treatment group
Active Comparator
干预措施: Oral estradiol valerate (Procedure)
结局指标
主要结局
Live birth rate
时间窗: 11 months
Number of women with live birth/ number of women randomized to the specific group. Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation.
次要结局
- Miscarriage rate(9 months)
- Cycle cancellation rate(1 month)
- Incidence of obstetric and perinatal complications(11 months)
- Incidence of neonatal complications(11 months)
- Ectopic pregnancy rate(2 months)
- Clinical pregnancy rate(2 months)
- Biochemical pregnancy rate(1.5 months)
- Birth weight(11 months)
研究者
研究点 (1)
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