Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ovarian Follicle |
Drug: Marvelon Drug: Nuvaring Drug: Letrozole |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971 |
- 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 ]
- To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. [ Time Frame: ongoing ]
| Enrollment: | 41 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Oral Contraceptive |
Drug: Marvelon
oral contraceptive
|
| Experimental: Contraceptive Ring |
Drug: Nuvaring
contraceptive vaginal ring
|
| Experimental: Aromatase Inhibitors |
Drug: Letrozole
Aromatase Inhibitors
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Principal Investigator: | Roger A Pierson | University of Saskatchewan |
More Information
No publications provided
| Responsible Party: | Dr. Roger Pierson, University of Saskatchewan |
| ClinicalTrials.gov Identifier: | NCT00565240 History of Changes |
| Other Study ID Numbers: | WHIRL-07-59 |
| Study First Received: | November 27, 2007 |
| Last Updated: | April 20, 2010 |
| Health Authority: | United States: Institutional Review Board Canada: Health Canada |
Keywords provided by University of Saskatchewan:
|
ovarian synchronization folliculogenesis |
Additional relevant MeSH terms:
|
Contraceptive Agents Desogestrel Contraceptives, Oral Letrozole Aromatase Inhibitors Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Contraceptive Agents, Female Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Progestins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic |
ClinicalTrials.gov processed this record on June 18, 2013