Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: Canadian Institutes of Health Research (CIHR)
• Treatments: Aromatase Inhibitors; Contraceptive Agents; Contraceptives, Oral; Desogestrel; Letrozole; NuvaRing

Criteria

Inclusion Criteria:

1. female volunteers of childbearing potential;

2. are first time users of OC or have discontinued OC at least 2 months prior to study entry;

3. age between 18 and 35 years old;

4. normal body mass index (18-30);

5. has signed consent form; and

6. is in good health as confirmed by medical history, physical examination

Exclusion Criteria:

1. a positive pregnancy test will automatically exclude the volunteer from participation in this study.

2. any contraindication for oral contraception use;

3. known hypersensitivity to Letrozole and co-administered medications;

4. irregular menstrual cycles;

5. ultrasonographic evidence of ovarian dysfunction, such as Polycystic Ovary Syndrome (PCOS);

6. history of pituitary tumor;

7. HIV, HBV, HCV infection;

8. vaginal infection;

9. abnormal ECG;

10. abnormal lab tests for blood profile, liver function and renal function;

11. uncontrolled diabetes and blood pressure;

12. pregnancy (suspected or diagnosed) or lactation;

13. history or suspicion of drug or alcohol abuse;

14. history of severe mental disorders;

15. participation in an investigational drug trial within the 30 days prior to selection;

16. 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.