Three Dimensional Ultrasonographic Detection of Human Ovulation
- Conditions
- Ovulation Disorder
- Interventions
- Procedure: Transvaginal ultrasound scansDiagnostic Test: Finger prick blood testDiagnostic Test: Urine test
- Registration Number
- NCT06433453
- Lead Sponsor
- University of Saskatchewan
- Brief Summary
The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 30
- Healthy biological females
- Regular menstrual cycles (21-35 days)
- BMI <18 or >30
- Pregnancy
- Breastfeeding mothers
- History of infertility
- History of hysterectomy or oophorectomy
- Reproductive health issues that can interfere with study outcomes
- Smoking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Indomethacin Indomethacin 50 MG Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. Indomethacin Transvaginal ultrasound scans Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. Indomethacin Finger prick blood test Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. Indomethacin Urine test Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
- Primary Outcome Measures
Name Time Method Daily measures of follicle diameters in each ovary (mm) 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) 8-16 days Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle
Luteinizing hormone (LH) level 8-16 days LH assay from dried blood spots and urine samples
Estradiol level 8-16 days Estradiol assay from dried blood spots and urine samples
Progesterone level 8-16 days Progesterone assay from dried blood spots and urine samples
Follicle stimulating hormone (FSH) level 8-16 days FSH assay from dried blood spots and urine samples
- Secondary Outcome Measures
Name Time Method Ovulation score 1 day A point system based on changes in follicle size, antrum size, follicle wall thickness, follicular vascularity, visualization of a rupture site, presence of irregular wall-antral borders, presence of internal echoes, visualization of a cumulus-oocyte complex, rise in serum LH, and rise in serum progesterone.
Endometrial thickness 8-16 days Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.
Trial Locations
- Locations (1)
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
🇨🇦Saskatoon, Saskatchewan, Canada