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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Experimental | Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin 50 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 8-16 days |
| Follicle stimulating hormone (FSH) level | FSH assay from dried blood spots and urine samples | 8-16 days |
| Luteinizing hormone (LH) level | LH assay from dried blood spots and urine samples | 8-16 days |
| Estradiol level | Estradiol assay from dried blood spots and urine samples | 8-16 days |
| Progesterone level | Progesterone assay from dried blood spots and urine samples | 8-16 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angela R Baerwald, PhD,MD,CCFP | Contact | 306-555-4200 | angela.baerwald@usask.ca | |
| Folasade A Bello, MBBS, FWACS | Contact | nike.bello@usask.ca |
| Name | Affiliation | Role |
|---|---|---|
| Angela R Baerwald, PhD,MD,CCFP | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan | Recruiting | Saskatoon | Saskatchewan | S7N0W8 | Canada |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D016482 | Urinalysis |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Transvaginal ultrasound scans | Procedure | Ultrasound scans done intermittently before and after an ovulatory or anovulatory event |
|
| Finger prick blood test | Diagnostic 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. |
|
|
| Urine test | Diagnostic Test | Early morning urine tests to assay reproductive hormones |
|
| Endometrial thickness |
Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure. |
| 8-16 days |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003950 | Diagnostic Techniques, Urological |
| D008919 | Investigative Techniques |