Ovulation Disorder
Conditions
Keywords
ovulation, 3D ultrasonography
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
Interventions
DRUGIndomethacin 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.
PROCEDURETransvaginal ultrasound scans
Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
DIAGNOSTIC_TESTFinger 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_TESTUrine test
Early morning urine tests to assay reproductive hormones
Sponsors
University of Saskatchewan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy biological females * Regular menstrual cycles (21-35 days)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progesterone level | 8-16 days | Progesterone assay from dried blood spots and urine samples |
| 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 |
| 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 |
| Follicle stimulating hormone (FSH) level | 8-16 days | FSH assay from dried blood spots and urine samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial thickness | 8-16 days | Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure. |
| 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. |
Countries
Canada
Contacts
Primary ContactAngela R Baerwald, PhD,MD,CCFP
Backup ContactFolasade A Bello, MBBS, FWACS
Outcome results
None listed