Mid-luteal Phase Synchronization of Ovarian Folliculogenesis in Women

University of Saskatchewan

Status: Completed

Conditions: Ovarian Follicle

Treatments: Drug: Nuvaring; Drug: Marvelon; Drug: Letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT00565240

WHIRL-07-59

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 4 patient groups

Oral Contraceptive

Experimental group

Treatment:

Drug: Marvelon

Contraceptive Ring

Experimental group

Treatment:

Drug: Nuvaring

Aromatase Inhibitors

Experimental group

Treatment:

Drug: Letrozole

Control

No Intervention group