## Protocol Section
### Identification Module
**NCT ID:** NCT06433453

**Brief Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation

**Official Title:** Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

#### Organization Study ID Info
**ID:** Bio 2757
#### Organization
**Class:** OTHER
**Full Name:** University of Saskatchewan
### Status Module
#### Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-22

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Saskatchewan

#### Responsible Party

**Investigator Affiliation:** University of Saskatchewan

**Investigator Full Name:** Angela Baerwald

**Investigator Title:** Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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

### Conditions Module

**Conditions:**

- Ovulation Disorder

**Keywords:**

- ovulation

- 3D ultrasonography

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Oral indomethacin 50 mg three times daily for 1-7 days. The administration is terminated when signs of anovulation are observed.

**Intervention Names:**

- Drug: Indomethacin 50 MG

- Procedure: Transvaginal ultrasound scans

- Diagnostic Test: Finger prick blood test

- Diagnostic Test: Urine test

**Label:** Indomethacin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Indomethacin

**Description:** 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.

**Name:** Indomethacin 50 MG

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Indomethacin

**Description:** Ultrasound scans done intermittently before and after an ovulatory or anovulatory event

**Name:** Transvaginal ultrasound scans

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Indomethacin

**Description:** 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.

**Name:** Finger prick blood test

**Other Names:**

- Dried blood spots

**Type:** DIAGNOSTIC_TEST

#### Intervention 4

**Arm Group Labels:**

- Indomethacin

**Description:** Early morning urine tests to assay reproductive hormones

**Name:** Urine test

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Daily ultrasound scans to demonstrate the disappearance of a preovulatory follicle and replacement with a corpus luteum

**Measure:** Daily measures of follicle diameters in each ovary (mm)

**Time Frame:** 8-16 days

**Description:** Daily ultrasound scans to demonstrate the preovulatory follicle transforming into a corpus luteum vs anovulatory follicle

**Measure:** Presence of corpus luteum (Y/N)

**Time Frame:** 8-16 days

**Description:** FSH assay from dried blood spots and urine samples

**Measure:** Follicle stimulating hormone (FSH) level

**Time Frame:** 8-16 days

**Description:** LH assay from dried blood spots and urine samples

**Measure:** Luteinizing hormone (LH) level

**Time Frame:** 8-16 days

**Description:** Estradiol assay from dried blood spots and urine samples

**Measure:** Estradiol level

**Time Frame:** 8-16 days

**Description:** Progesterone assay from dried blood spots and urine samples

**Measure:** Progesterone level

**Time Frame:** 8-16 days

#### Secondary Outcomes

**Description:** 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.

**Measure:** Ovulation score

**Time Frame:** 1 day

**Description:** Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.

**Measure:** Endometrial thickness

**Time Frame:** 8-16 days

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** angela.baerwald@usask.ca

**Name:** Angela R Baerwald, PhD,MD,CCFP

**Phone:** 306-555-4200

**Role:** CONTACT

**Contact 2:**

**Email:** nike.bello@usask.ca

**Name:** Folasade A Bello, MBBS, FWACS

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Saskatoon

**Contacts:**

***Contact 1:***

- **Email:** nike.bello@usask.ca

- **Name:** Nike Bello, PhD Candidate

- **Role:** CONTACT

***Contact 2:***

- **Email:** angela.baerwald@usask.ca

- **Name:** Angela Baerwald, PhD MD

- **Role:** CONTACT

***Contact 3:***

- **Name:** Angela R Baerwald, PhD CCRP

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Nike Bello, MD MBBS MPH

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Roger PIERSON, PHD

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan

**State:** Saskatchewan

**Status:** RECRUITING

**Zip:** S7N0W8

#### Overall Officials

**Official 1:**

**Affiliation:** University of Saskatchewan

**Name:** Angela R Baerwald, PhD,MD,CCFP

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4184

- Name: Anovulation

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000006074

- Term: Gout Suppressants

- ID: D000015149

- Term: Tocolytic Agents

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000016861

- Term: Cyclooxygenase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10257

- Name: Indomethacin

- Relevance: HIGH

- As Found: Predicting

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M17869

- Name: Tocolytic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M19209

- Name: Cyclooxygenase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007213

- Term: Indomethacin

### Misc Info Module

- Version Holder: 2024-05-31
