NCT06433453

Three Dimensional Ultrasonographic Detection of Human Ovulation

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Saskatchewan · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Conditions

• Ovulation Disorder

Interventions

Type	Name	Description
DRUG	Indomethacin 50 MG	The medication is commenced when a preovulatory follicle is observed. It will be administered for a minimum of one day, up to a maximum of 7 days. It will be discontinued when anovulation is observed.
PROCEDURE	Transvaginal ultrasound scans	Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
DIAGNOSTIC_TEST	Finger prick blood test	Capillary blood extracted from a finger prick. Blood spots are collected on a specialized card, dried and frozen before reproductive hormones are assayed from them.
DIAGNOSTIC_TEST	Urine test	Early morning urine tests to assay reproductive hormones

Timeline

• Start date: 2024-04-22
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2024-05-29
• Last updated: 2024-05-29

Locations

1 site across 1 country: Canada