Three Dimensional Ultrasonographic Detection of Human Ovulation

May 22, 2024 updated by: Angela Baerwald, University of Saskatchewan

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N0W8
        • Recruiting
        • Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela R Baerwald, PhD CCRP
        • Sub-Investigator:
          • Nike Bello, MD MBBS MPH
        • Sub-Investigator:
          • Roger PIERSON, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indomethacin
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
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.
Procedure: Transvaginal ultrasound scans
Ultrasound scans done intermittently before and after an ovulatory or anovulatory event
Diagnostic test: Finger 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.
Other Names:
  • Dried blood spots
Diagnostic test: Urine test
Early morning urine tests to assay reproductive hormones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8-16 days
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
8-16 days
Follicle stimulating hormone (FSH) level
Time Frame: 8-16 days
FSH assay from dried blood spots and urine samples
8-16 days
Luteinizing hormone (LH) level
Time Frame: 8-16 days
LH assay from dried blood spots and urine samples
8-16 days
Estradiol level
Time Frame: 8-16 days
Estradiol assay from dried blood spots and urine samples
8-16 days
Progesterone level
Time Frame: 8-16 days
Progesterone assay from dried blood spots and urine samples
8-16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovulation score
Time Frame: 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.
1 day
Endometrial thickness
Time Frame: 8-16 days
Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.
8-16 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: Angela R Baerwald, PhD,MD,CCFP, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

May 15, 2024

First Submitted That Met QC Criteria

May 22, 2024

First Posted (Actual)

May 29, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio 2757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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