Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7N 0W8
- Royal University Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- female volunteers of childbearing potential;
- are first time users of OC or have discontinued OC at least 2 months prior to study entry;
- age between 18 and 35 years old;
- normal body mass index (18-30);
- has signed consent form; and
- is in good health as confirmed by medical history, physical examination
Exclusion Criteria:
- a positive pregnancy test will automatically exclude the volunteer from participation in this study.
- any contraindication for oral contraception use;
- known hypersensitivity to Letrozole and co-administered medications;
- irregular menstrual cycles;
- ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);
- history of pituitary tumor;
- HIV, HBV, HCV infection;
- vaginal infection;
- abnormal ECG;
- abnormal lab tests for blood profile, liver function and renal function;
- uncontrolled diabetes and blood pressure;
- pregnancy (suspected or diagnosed) or lactation;
- history or suspicion of drug or alcohol abuse;
- history of severe mental disorders;
- participation in an investigational drug trial within the 30 days prior to selection;
exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
- history of, or actual, thrombophlebitis or thromboembolic disorders.
- history of, or actual, cerebrovascular disorders.
- history of, or actual, myocardial infarction or coronary artery disease.
- acute liver disease.
- history of, or actual, benign or malignant liver tumors.
- history of, or suspected, carcinoma of the breast.
- known, or suspected, estrogen-dependent neoplasia.
- undiagnosed abnormal vaginal bleeding.
- any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Oral Contraceptive
|
oral contraceptive
|
|
Experimental: Contraceptive Ring
|
contraceptive vaginal ring
|
|
Experimental: Aromatase Inhibitors
|
Aromatase Inhibitors
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate differences in the mechanisms of atresia, initiation of a new synchronous follicular wave, interval to follicle wave emergence, interval to emergence of dominant follicle, interval to menstruation, and endometrial thickness/pattern.
Time Frame: 24-28 days
|
24-28 days
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.
Time Frame: ongoing
|
ongoing
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Roger A Pierson, University of Saskatchewan
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Estimate)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Progestins
- Letrozole
- Desogestrel
- NuvaRing
Other Study ID Numbers
Other Study ID Numbers
- WHIRL-07-59
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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