Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433453
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-15
Brief Title:
Three Dimensional Ultrasonographic Detection of Human Ovulation
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None