Clinical trial

Three Dimensional Ultrasonographic Detection of Human Ovulation and Anovulation

NCT06433453

Name

Bio 2757

Description

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

Trial arms

Trial start

2024-04-22

Estimated PCD

2024-12-31

Trial end

2025-03-31

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Indomethacin

Transvaginal ultrasound scans

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

Arms:

Indomethacin

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.

Arms:

Indomethacin

Other names:

Dried blood spots

Urine test

Early morning urine tests to assay reproductive hormones

Arms:

Indomethacin

Size

Primary endpoint

Daily measures of follicle diameters in each ovary (mm)

8-16 days

Presence of corpus luteum (Y/N)

8-16 days

Follicle stimulating hormone (FSH) level

8-16 days

Luteinizing hormone (LH) level

8-16 days

Estradiol level

8-16 days

Progesterone level

8-16 days

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-05-29

1 organization

1 product

1 indication

Organization

University of Saskatchewan

Product

Indomethacin

Indication

Ovulatory dysfunction