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Sponsors and Collaborators: |
University of Saskatchewan Women's Health Imaging Research Laboratory Canadian Institutes of Health Research (CIHR) |
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Information provided by: | University of Saskatchewan |
ClinicalTrials.gov Identifier: | NCT00204438 |
We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women. Clinically, we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development and/or atresia.
Condition | Intervention |
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Contraception |
Drug: 0.15mg desogestrel /0.03mg ethinyl estradiol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
Official Title: | Follicular Profiles After Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle |
Estimated Enrollment: | 45 |
Study Start Date: | February 2002 |
Estimated Study Completion Date: | December 2002 |
This study is a single-centre, randomized, open-label, double-controlled protocol to study the patterns of ovarian follicular growth and regression in women administered 0.15mg desogestrel /0.03mg ethinyl estradiol at different stages of the follicular phase of the menstrual cycle.
We tracked the growth and regression of dominant follicles after administration of OC by means of highly sophisticated transvaginal ultrasonography and computerized image analysis techniques. The extremely high resolution ultrasonography of the ovarian follicles and the computer-assisted image analysis are unique to the Women’s Health Imaging Research Laboratory (WHIRL) at the University of Saskatchewan. The synergyne (© R.A. Pierson) image analysis program was developed in the WHIRL and has the ability to allow assessment of the physiologic status of follicles as small as 6 to 10 mm. This unique protocol will allow us to characterize patterns of follicular growth and atresia under the suppressive effects of oral contraception, as well as the assessment of anovulatory follicles which may develop when OCs are administered at advanced stages of follicular development.
The working hypothesis is that the administration of monophasic OCs prior to and during the time of physiologic selection of the dominant follicle will prevent the development of an ovulatory follicle (selection occurs when the dominant follicle reaches 10mm [Baerwald & Pierson, unpublished data]). In addition, we hypothesize that administration of OCs after selection of the dominant follicle, at more advanced stages of follicular development will result in 1 of 4 scenarios: 1.) Ovulation of the dominant follicle, 2.) Regression of the dominant follicle, 3). Formation of a Hemorrhagic Anovulatory follicle (HAF) or Luteinized Unruptured Follicle (LUF), or 4.) Formation of a follicular cyst. We hypothesize that atresia of dominant follicles and formation of anovulatory follicular structures will be associated with limited endometrial development. In testing these hypotheses, we will determine if OCs can safely and effectively be administered at any time during the follicular phase of the menstrual cycle.
This study will evaluate the ovarian and uterine responses to administration of a combined dose of 0.15mg desogestrel /0.03mg ethinyl estradiol at 1 of 3 different stages of the follicular phase of the menstrual cycle. The objectives of the trial are to:
After screening measurements confirm subject eligibility, subjects will be randomized to initiate OC therapy at one of three different times of the menstrual cycle:
Experimental Group #1: receives OCs when the dominant follicle reaches 10mm Experimental Group #2: receives OCs when the dominant follicle reaches 14mm Experimental Group #3: receives OCs when the dominant follicle reaches 18mm
Fifteen women will be randomized to each of the 3 experimental groups in a stratified design scheme. Data collected from an ongoing OC trial (BMC# 2000-169) will serve as OC control data (n=15). Data collected from a previous study (BMC# 1988-80) will serve as natural cycle control data (n=60).
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Saskatchewan | |
Ob-Gyn Royal University Hospital | |
Saskatoon, Saskatchewan, Canada, S7N 0W8 |
Principal Investigator: | Roger A Pierson, MS PhD | University of Saskatchewan |
Study ID Numbers: | BMC 2001-249, CIHR MOP - 11489 |
Study First Received: | September 12, 2005 |
Last Updated: | October 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00204438 |
Health Authority: | Canada: Health Canada; Canada: Ethics Review Committee |
female contraception oral contraceptive emergency contraceptive |
ovary follicle ovulation |
Desogestrel Estradiol 3-benzoate Estradiol valerate Ethinyl Estradiol |
Emergencies Estradiol 17 beta-cypionate Polyestradiol phosphate Estradiol |
Estrogens Contraceptive Agents Therapeutic Uses Progestins Contraceptives, Oral Physiological Effects of Drugs |
Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptives, Oral, Synthetic Reproductive Control Agents Hormones Pharmacologic Actions |