Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- positive pregnancy test
研究概览
简要总结
Patients will be subjected to:
A. Clinical evaluation including history and examination
B. Ultrasonographic evaluation of Ovarian Morphometry:
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
C. Laboratory Evaluation:
Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:
- Anti Mullerian Hormone (AMH)
- Follicle Stimulating Hormone (FSH)
- Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)
详细描述
Patients will be subjected to:
A. Clinical evaluation including history and examination
B. Ultrasonographic evaluation of Ovarian Morphometry:
- Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
- Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
- Antral follicle count will be determined for each patient
C. Laboratory Evaluation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •less than 39 years old,
- •normal menstrual cycle with a range of 24 to 35 days
- •normal seum prolactin.
- •normal uterine cavity determined by previous hysterosalpingography or hysteroscopy
排除标准
- •endometriosis
- •Women with endometriosis;
- •abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.
研究组 & 干预措施
pregnant
women with positive pregnancy test after induction of ovulation and ICSI
干预措施: human menopausal gonadotropin (Drug)
Not pregnant
women with negative pregnancy test after induction of ovulation and ICSI
干预措施: human menopausal gonadotropin (Drug)
结局指标
主要结局
positive pregnancy test
时间窗: 14 days after embryo transfer
次要结局
未报告次要终点
研究者
Ahmed M Maged, MD
Assistant professor
Cairo University