Is GnRH Agonist Plus Letrozole a Better Choice Than GnRH Agonist Alone in Adenomyosis Cases Undergoing Frozen Embryo Transfer?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Purpose of the Study:
To compare the effectiveness of GnRH agonist downregulation alone versus GnRH agonist combined with letrozole in improving pregnancy outcomes in women with adenomyosis undergoing frozen embryo transfer (FET).
Research Question:
Is the combined use of GnRH agonist and letrozole more effective than GnRH agonist downregulation alone in achieving better ongoing pregnancy rates in adenomyosis cases undergoing FET?
Hypothesis:
Null Hypothesis (H₀): The combined use of GnRH agonist and letrozole is not more effective than GnRH agonist downregulation alone in achieving a higher ongoing pregnancy rate in adenomyosis cases undergoing FET.
Study Outcomes:
Primary Outcome: Ongoing pregnancy rate at 12 weeks of gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of adenomyosis confirmed via transvaginal ultrasound as per MUSA criteria History of infertility requiring frozen embryo transfer (FET). Availability of at least one good-quality frozen embryo for transfer
排除标准
- •BMI ≥ 30 kg/m2 Presence of endocrine disorders; (uncontrolled diabetes mellitus, / hyperprolactinemia, thyroid dysfunction, Congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome Previous major uterine surgery Gestational carrier Fertility preservation
研究组 & 干预措施
Group A
干预措施: GnRH agonist downregulation (Drug)
Group B
干预措施: GnRH agonist and Letrozole (Drug)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 weeks of gestation
Presence of gestational sacs with a heartbeat at the 12th gestational week. The ongoing pregnancy rate will be calculated using the below formula. Ongoing pregnancy rate: (the number of ongoing pregnancy cases/the number of clinical pregnancy cases) × 100%
次要结局
- Chemical Pregnancy rate(4 weeks after embryo transfer)
- 1st trimester loss(12 weeks of gestation)
- Live Birth Rate(Post delivery after completion of 20 weeks of gestation)
- Implantation Rate(4 weeks after embryo transfer)
- Biochemical loss rate(4 weeks after embryo transfer)
- 2nd trimester loss(20 weeks of gestation)