Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

• Sponsor: University of Saskatchewan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00565240
• Collaborator: Canadian Institutes of Health Research (CIHR) (Other)
• Enrollment: 41
• Location: 1
• Arms: 4
• Duration (Months): 22
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Follicle	Drug: Marvelon; Drug: Nuvaring; Drug: Letrozole	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
• Study Start Date: Nov 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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

1. To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. [ongoing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8

Sponsors and Collaborators

• University of Saskatchewan
• Canadian Institutes of Health Research (CIHR)

Investigators

• Principal Investigator: Roger A Pierson, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00565240
• Other Study ID Numbers: WHIRL-07-59
• First Posted: Nov 29, 2007
• Last Update Posted: Apr 22, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: ovarian synchronization; folliculogenesis
• Additional relevant MeSH terms: Letrozole; NuvaRing; Desogestrel

Study Results

No Results Posted as of Apr 22, 2010