NCT01237106已完成不适用
In Vitro Maturation for Polycystic Ovary Syndrome (PCOS)- A Pilot Study
University Reproductive Associates3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
研究概览
简要总结
This pilot study will be a prospective investigation to study the efficacy and safety of In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10 subjects total in this Study. There will be no blinding to treatment.
In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting pregnancy through the use of Assisted Reproductive Technology (ART).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •10 women between the ages of 18-34 inclusive at time of signing Informed Consent Form.
- •A diagnosis of PCOS by their primary MD
- •An Antral Follicular Count (AFC) of > 12 on one ovary on at least one occasion
- •A day 3 FSH level of <8 IU/mL
- •In good general health off of current medications which may confound response to study medications.
- •Desire to seek pregnancy actively during the study period by IVF-ICSI.
- •A normal uterine cavity must have been confirmed by either hydrosonogram or hysteroscopy within two years of entering the study.
- •Male partner able to provide adequate semen sample by ejaculation (no TESE)
排除标准
- •Current pregnancy
- •Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
- •Patients with poorly controlled diabetes (HgB A1C over 8.0 ng/dL).
- •Patients enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
- •Patients with significant anemia (Hemoglobin < 10 mg/dL).
- •Patients enrolled simultaneously into other investigative studies that would interfere with this research study.
- •have any contraindications to using birth control pills (oral contraceptives) as determined by the attending physician (e.g. history of thromboembolism or estrogen-dependent malignancy, such as breast cancer, etc.) -
结局指标
主要结局
Incidence of Biochemical Pregnancy (defined as a rising Beta-HCG level).
时间窗: 6 months
次要结局
- rates of maturation and fertilization(6 months)
- Incidence of Ovarian Hyperstimulation Syndrome (OHSS)(6 months)
- live births(1 1/2 years)
- number of immature oocytes retrieved(6 months)
研究者
Peter McGovern, MD
Medical Director
University Reproductive Associates
研究点 (3)
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