NCT03767569Unknown3 期
Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Serum testosterone level after 12 weeks of administration of Myo-Inositol
研究概览
简要总结
A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-40 years
- •PCOS phenotypes A, B and C
- •Signed informed consent
排除标准
- •Other relevant endocrine disorders
- •Contraindications to the use of gonadotropins
- •Endometriosis grade 3-4
- •BMI > 35
研究组 & 干预措施
Myo-inositol
Experimental
Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)
干预措施: Myo-inositol (Drug)
Folic acid
Other
Folic acid 0.4 mg daily during 12 weeks before start of ART
干预措施: Folic Acid (Drug)
结局指标
主要结局
Serum testosterone level after 12 weeks of administration of Myo-Inositol
时间窗: 2 years
次要结局
- Number of mature oocytes(2 years)
- Embryo quality(2 years)
- Live birth rate in fresh cycle(2 years)
- Consumption of gonadotrophins(2 years)
- Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol(2 years)
- Clinical pregnancy rate (%)(2 years)
- Cumulative live birth rate after 1 cycle(2 years)
- Ovarian Hyperstimulation Syndrome rate(2 years)
- Stimulation days(2 years)
- Implantation rate (%)(2 years)
研究者
研究点 (1)
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