Ovulation DisorderPhase 4NCT06433453
Three Dimensional Ultrasonographic Detection of Human Ovulation
A Phase 4 study testing Indomethacin 50 MG, Transvaginal ultrasound scans and Finger prick blood test in people with Ovulation Disorder, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovulation Disorder
- What is being tested?
- Indomethacin 50 MG, Transvaginal ultrasound scans and Finger prick blood test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 22 Apr 2024to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy biological females
- Regular menstrual cycles (21-35 days)
Who cannot join
- BMI <18 or >30
- Pregnancy
- Breastfeeding mothers
- History of infertility
- History of hysterectomy or oophorectomy
- Reproductive health issues that can interfere with study outcomes
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Folasade A Bello, MBBS, FWACS contact
Canada1 site, 1 recruiting
- Recruiting
Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
Saskatoon, Saskatchewan, S7N0W8
Nike Bello, PhD Candidate, nike.bello@usask.ca
Angela Baerwald, PhD MD, angela.baerwald@usask.ca
About this study
Official title: Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation
The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.
Read the 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
- Being tested
- Indomethacin 50 MG, Transvaginal ultrasound scans, Finger prick blood test, Urine test
- Keywords
- ovulation, 3D ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin 50 MGDrug
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.
Transvaginal ultrasound scansProcedure or surgery
Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
Finger prick blood testDiagnostic test
Also called Dried blood spots
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 testDiagnostic test
Early morning urine tests to assay reproductive hormones
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin | Experimental | Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. Receives: Drug: Indomethacin 50 MG; Procedure: Transvaginal ultrasound scans; Diagnostic Test: Finger prick blood test; Diagnostic Test: Urine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 8-16 days
Follicle stimulating hormone (FSH) level
FSH assay from dried blood spots and urine samples
Measured: 8-16 days
Luteinizing hormone (LH) level
LH assay from dried blood spots and urine samples
Measured: 8-16 days
Estradiol level
Estradiol assay from dried blood spots and urine samples
Measured: 8-16 days
Progesterone level
Progesterone assay from dried blood spots and urine samples
Measured: 8-16 days
Secondary outcomes (2)
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.
Measured: 1 day
Endometrial thickness
Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.
Measured: 8-16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start22 Apr 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Baerwald, University of Saskatchewan
- Investigators
- Angela R Baerwald, PhD,MD,CCFP, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433453
- Sponsor's protocol ID
- Bio 2757
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation
- ClinicalTrials.gov ID
- NCT06433453
- Acronym / sponsor ID
- Bio 2757
- Conditions
- Ovulation Disorder
- Keywords
- ovulation, 3D ultrasonography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 29 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | Experimental | Drug: Indomethacin 50 MG, Procedure: Transvaginal ultrasound scans, Diagnostic Test: Finger prick blood test, Diagnostic Test: Urine testOral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy biological females
- Regular menstrual cycles (21-35 days)
Key exclusion criteria (17 listed)
- BMI <18 or >30
- Pregnancy
- Breastfeeding mothers
- History of infertility
- History of hysterectomy or oophorectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin 50 MGThe 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. | Drug | Indomethacin |
| Transvaginal ultrasound scansUltrasound scans done intermittently before and after an ovulatory or anovulatory event | Procedure or surgery | Indomethacin |
| Finger prick blood testAlso: Dried blood spotsCapillary 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 | Indomethacin |
| Urine testEarly morning urine tests to assay reproductive hormones | Diagnostic test | Indomethacin |
Primary outcome
Daily measures of follicle diameters in each ovary (mm)
Time frame: 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)
Time frame: 8-16 days
Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle
Follicle stimulating hormone (FSH) level
Time frame: 8-16 days
FSH assay from dried blood spots and urine samples
Luteinizing hormone (LH) level
Time frame: 8-16 days
LH assay from dried blood spots and urine samples
Estradiol level
Time frame: 8-16 days
Estradiol assay from dried blood spots and urine samples
Progesterone level
Time frame: 8-16 days
Progesterone assay from dried blood spots and urine samples
2 secondary outcomes
Ovulation score
Time frame: 1 day
Endometrial thickness
Time frame: 8-16 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Folasade A Bello, MBBS, FWACS contact
Angela R Baerwald, PhD,MD,CCFP principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin 50 MG, Transvaginal ultrasound scans and Finger prick blood test in people with Ovulation Disorder, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angela R Baerwald, PhD,MD,CCFP (306-555-4200, angela.baerwald@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily measures of follicle diameters in each ovary (mm) (time frame: 8-16 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.