Three Dimensional Ultrasonographic Detection of Human Ovulation

Last updated: May 22, 2024
Sponsor: University of Saskatchewan
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Transvaginal ultrasound scans

Finger prick blood test

Urine test

Clinical Study ID

NCT06433453
Bio 2757
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy biological females

  • Regular menstrual cycles (21-35 days)

Exclusion

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 hormonalcontraception)

  • History of metabolic syndrome or untreated thyroid disease

  • Contra-indication to non-steroidal anti-inflammatory drug (NSAID) use. Theseinclude:

  • 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 Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Transvaginal ultrasound scans
Phase: 4
Study Start date:
April 22, 2024
Estimated Completion Date:
March 31, 2025

Study 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

Connect with a study center

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

    Saskatoon, Saskatchewan S7N0W8
    Canada

    Active - Recruiting

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