Three Dimensional Ultrasonographic Detection of Human Ovulation

Ovulation Disorder Clinical Trial

Official title:

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06433453
• Other study ID #: Bio 2757
• Status: Recruiting
• Phase: Phase 4
• Start date: April 22, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2024
• Source: University of Saskatchewan
• Contact: Angela R Baerwald, PhD,MD,CCFP
• Phone: 306-555-4200
• Email: angela.baerwald[@]usask.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovulation Disorder

Intervention

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.
• Urine test
Early morning urine tests to assay reproductive hormones

Locations

Country	Name	City	State
Canada	Department of Obstetrics, Gynecology and Reproductive Sciences, University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Follicle stimulating hormone (FSH) level	FSH assay from dried blood spots and urine samples	8-16 days
Primary	Luteinizing hormone (LH) level	LH assay from dried blood spots and urine samples	8-16 days
Primary	Estradiol level	Estradiol assay from dried blood spots and urine samples	8-16 days
Primary	Progesterone level	Progesterone assay from dried blood spots and urine samples	8-16 days
Secondary	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.	1 day
Secondary	Endometrial thickness	Endometrial thickness and appearance to support the diagnosis of ovulation or ovulation failure.	8-16 days