Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

Study Overview
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Brief Summary
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We hypothesize that administration of an aromatase inhibitor (AI) and hormonal contraceptives (HC) in the mid-luteal phase of the menstrual cycle will result in atresia of the follicles in the extant wave and cause synchronous re-emergence of a new follicular wave. We anticipate that this will provide us with information to facilitate the development of a new method for ovarian synchronization; a safer, more effective ovulation induction therapy; a new method for emergency contraception; and a greater understanding of human folliculogenesis.

Official Title
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Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971

Conditions
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Ovarian Follicle

Intervention / Treatment
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* Drug: Marvelon
* Drug: Nuvaring
* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Contraceptive<br> | Drug: Marvelon<br>* oral contraceptive<br>|
| Experimental: Contraceptive Ring<br> | Drug: Nuvaring<br>* contraceptive vaginal ring<br>|
| Experimental: Aromatase Inhibitors<br> | Drug: Letrozole<br>* Aromatase Inhibitors<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 24-28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. |  | ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian synchronization, folliculogenesis