A Phase 4 interventional study of Indomethacin 50 MG and Transvaginal ultrasound scans in Ovulation Disorder, sponsored by University of Saskatchewan. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University of Saskatchewan · Phase 4, Interventional, and Diagnostic
The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.
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
University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.
Drug: Indomethacin 50 MG · Procedure: Transvaginal ultrasound scans · Diagnostic Test: Finger prick blood test · Diagnostic Test: Urine test
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.
Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
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.
Also known as: Dried blood spots
Early morning urine tests to assay reproductive hormones
Daily measures of follicle diameters in each ovary (mm)
Daily ultrasound scans to demonstrate the disappearance of a preovulatory follicle and replacement with a corpus luteum
Time frame: 8-16 days
Presence of corpus luteum (Y/N)
Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle
Time frame: 8-16 days
Follicle stimulating hormone (FSH) level
FSH assay from dried blood spots and urine samples
Time frame: 8-16 days
Luteinizing hormone (LH) level
LH assay from dried blood spots and urine samples
Time frame: 8-16 days
Estradiol level
Estradiol assay from dried blood spots and urine samples
Time frame: 8-16 days
Progesterone level
Progesterone assay from dried blood spots and urine samples
Time frame: 8-16 days
Ovulation score
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.
Time frame: 1 day
Endometrial thickness
Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.
Time frame: 8-16 days
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Dec 2024, 8 months after the start.
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This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indomethacin