Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Daily measures of follicle diameters in each ovary (mm)
研究概览
简要总结
The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.
详细描述
Thirty healthy participants will be enrolled. When their dominant ovarian follicle has a diameter of 16 mm or more, an anti-prostaglandin medication, indomethacin 30 mg, will be administered three times daily for 1-7 days. Anti-prostaglandins are known to cause anovulation. Daily 2D and 3D ultrasound scans, and urine and finger prick blood tests for reproductive hormonal assays will be performed. The medication will be discontinued once ultrasound features of anovulation are observed. These study procedures will also be carried out on days 1, 3 and 7 after anovulation.
A second cohort of 30 participants who had 2D and 3D ultrasound scans and hormonal assays in a natural cycle in a previous study (Bio 2080; NCT05531357) will also be evaluated.
These two groups represent the anovulatory and ovulatory groups, respectively, and their 2D and 3D ultrasound features will be compared. With 2D ultrasonography as a gold standard, the study aims to determine if 3D ultrasonography improves ovulation assessment and improves the recognition of anovulatory follicles in infertility treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy biological females
- •Regular menstrual cycles (21-35 days)
排除标准
- •BMI <18 or >30
- •Pregnancy
- •Breastfeeding mothers
- •History of infertility
- •History of hysterectomy or oophorectomy
- •Reproductive health issues that can interfere with study outcomes
- •Not on any hormonal medication that affects reproduction (including hormonal contraception)
- •History of metabolic syndrome or untreated thyroid disease
- •Contra-indication to non-steroidal anti-inflammatory drug (NSAID) use. These include:
- •Gastric ulcers or gastro-intestinal bleeding
- •History of myocardial infarction or a coronary artery bypass
- •Cerebrovascular disease
- •Hypertension
- •Chronic or acute renal failure
- •Severe liver disease
- •Nasal polyp syndrome
研究组 & 干预措施
Indomethacin
Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
干预措施: Transvaginal ultrasound scans (Procedure)
Indomethacin
Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
干预措施: Indomethacin 50 MG (Drug)
Indomethacin
Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
干预措施: Finger prick blood test (Diagnostic Test)
Indomethacin
Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
干预措施: Urine test (Diagnostic Test)
结局指标
主要结局
Daily measures of follicle diameters in each ovary (mm)
时间窗: 8-16 days
Daily ultrasound scans to demonstrate the disappearance of a preovulatory follicle and replacement with a corpus luteum
Presence of corpus luteum (Y/N)
时间窗: 8-16 days
Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle
Luteinizing hormone (LH) level
时间窗: 8-16 days
LH assay from dried blood spots and urine samples
Estradiol level
时间窗: 8-16 days
Estradiol assay from dried blood spots and urine samples
Progesterone level
时间窗: 8-16 days
Progesterone assay from dried blood spots and urine samples
Follicle stimulating hormone (FSH) level
时间窗: 8-16 days
FSH assay from dried blood spots and urine samples
次要结局
- Ovulation score(1 day)
- Endometrial thickness(8-16 days)
研究者
Angela Baerwald
Associate Professor
University of Saskatchewan