Three Dimensional Ultrasonographic Detection of Human Ovulation

NCT06433453 | Recruiting Phase 4

• 1 other identifier: Bio 2757
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The research aims to compare diagnosis of ovulation and anovulation in 2D and 3D ultrasonography.

Conditions

Ovulation Disorder

Keywords

ovulation; 3D ultrasonography

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (2)

• Ovulation score

  1 day

• Endometrial thickness

  8-16 days

Study Arms (1)

Indomethacin

EXPERIMENTAL

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

Interventions

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.

Indomethacin

Transvaginal ultrasound scans PROCEDURE

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

Indomethacin

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.

Also known as: Dried blood spots

Indomethacin

Urine test DIAGNOSTIC_TEST

Early morning urine tests to assay reproductive hormones

Indomethacin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy biological females
• Regular menstrual cycles (21-35 days)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan

Saskatoon, Saskatchewan, S7N0W8, Canada

RECRUITING

MeSH Terms

Interventions

Indomethacin; Urinalysis

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Angela R Baerwald, PhD,MD,CCFP

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela R Baerwald, PhD,MD,CCFP

CONTACT

306-555-4200; angela.baerwald@usask.ca

Folasade A Bello, MBBS, FWACS

CONTACT

nike.bello@usask.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 29, 2024
• Study Start: April 22, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)