Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

Ovarian Follicle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565240
• Other study ID #: WHIRL-07-59
• Status: Completed
• Phase: N/A
• First received: November 27, 2007
• Last updated: April 20, 2010
• Start date: November 2007
• Est. completion date: September 2009

Study information

• Verified date: April 2010
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ovarian Follicle

Intervention

Drug:
• Marvelon
oral contraceptive
• Nuvaring
contraceptive vaginal ring
• Letrozole
Aromatase Inhibitors

Locations

Country	Name	City	State
Canada	Royal University Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.		ongoing