Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00565240
Recruitment Status : Completed
First Posted : November 29, 2007
Last Update Posted : April 22, 2010
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of Saskatchewan

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

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

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. [ Time Frame: 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. [ Time Frame: ongoing ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00565240

Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Sponsors and Collaborators
University of Saskatchewan
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Roger A Pierson University of Saskatchewan

Responsible Party: Dr. Roger Pierson, University of Saskatchewan Identifier: NCT00565240     History of Changes
Other Study ID Numbers: WHIRL-07-59
First Posted: November 29, 2007    Key Record Dates
Last Update Posted: April 22, 2010
Last Verified: April 2010

Keywords provided by University of Saskatchewan:
ovarian synchronization

Additional relevant MeSH terms:
Contraceptive Agents
Aromatase Inhibitors
Contraceptives, Oral
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic