A Randomized Controlled Trial of NuvaRing® Versus Combined Oral Contraceptive Pills for Pre-treatment in In-Vitro Fertilization (IVF) Cycles
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 主要终点
- Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
研究概览
简要总结
The newly designed contraceptive ring, Nuvaring has a lower total steroid dose, and medications are delivered locally. It has been proven to be as safe and effective as the combined OCP in ovarian suppression and preventing ovulation with fewer side effects due to minimal systemic absorption. Following a single vaginal insertion, steroid concentrations remain stable for up to 4 weeks. It is hypothesized that Nuvaring may, therefore lead to better compliance, tolerability and acceptance by patients requiring ovarian suppression prior to COH for IVF.
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
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients less than 38 years of age.
- •Healthy women starting their first IVF/ICSI cycle.
- •No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
- •Consent to randomization.
排除标准
- •Any contraindication to COC use.
- •Hypersensitivity to Nuva ring or any of its components.
- •Language barrier to consent.
研究组 & 干预措施
Combined oral contraceptive pill
OCP for IVF pre-treatment
干预措施: marvelon (Drug)
NuvaRing
NuvaRing for IVF pre-treatment
干预措施: NuvaRing (Drug)
结局指标
主要结局
Incidence of Side Effects of Oral Contraceptives Such as Abnormal Bleeding, Headache, Breast Discomfort, Bloating and Mood Swings (See Description)
时间窗: patients were followed for the duration of an in-vitro fertilization cycle- 2 months
abnormal bleeding, intermittent bleeding, headache, breast discomfort, bloating, mood swings, nausea, vaginal discharge, vomitting, weight gain
次要结局
未报告次要终点
研究者
Kimberly Liu
Physician
University of Toronto