Clinical trial NCT00565240: Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women
Official title: Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women Protocol: WHIRL-07-2971
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Follicle
Keywords: ovarian synchronization
folliculogenesis
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2007-11-29
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 24-28 days
Secondary outcomes:
measure: To evaluate between treatment group differences in ultrasonographic image attributes of follicular structures that develop after administration of treatment.
timeFrame: ongoing
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Roger A Pierson
role: PRINCIPAL_INVESTIGATOR
References: