Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00565240
First received: November 27, 2007
Last updated: April 20, 2010
Last verified: April 2010

November 27, 2007
April 20, 2010
November 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00565240 on ClinicalTrials.gov Archive Site
To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment. [ Time Frame: ongoing ]
Same as current
Not Provided
Not Provided
 
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Ovarian Follicle
  • Drug: Marvelon
    oral contraceptive
  • Drug: Nuvaring
    contraceptive vaginal ring
  • Drug: Letrozole
    Aromatase Inhibitors
  • Experimental: Oral Contraceptive
    Intervention: Drug: Marvelon
  • Experimental: Contraceptive Ring
    Intervention: Drug: Nuvaring
  • Experimental: Aromatase Inhibitors
    Intervention: Drug: Letrozole
  • No Intervention: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00565240
WHIRL-07-59
Not Provided
Dr. Roger Pierson, University of Saskatchewan
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Roger A Pierson University of Saskatchewan
University of Saskatchewan
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP