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
  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

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00565240

Locations
Canada, Saskatchewan
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
  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 July 20, 2014