Aromatase Inhibitor Effects on Ovarian Function During the Follicular and Early Luteal Phase in Women

Summary

A single center, open label randomized clinical trial designed to examine ovarian follicular dynamics following attempted atresia induction during the late follicular and early luteal phase of the menstrual cycle using an aromatase inhibitor.

We hypothesize that administration of an aromatase inhibitor (AI) at biologically important times of the natural menstrual cycle will cause ovulatory failure in women with preovulatory follicles and failure of luteogenesis in women who have recently ovulated. It is proposed that atresia of the dominant follicle and formation of anovulatory structures will be associated with arrested endometrial development and a shortened interval to menstrual bleeding (3 days). We anticipate that this will provide us with information to facilitate the development of a new method for emergency contraception and a greater understanding of human folliculogenesis.

The rationale for the proposed research project is based on the ovarian synchronization concepts developed and documented in the bovine model in the Reproductive Science and Medicine Research group at the University of Saskatchewan combined with novel human ovarian wave concepts of folliculogenesis first elucidated in the Women's Health Imaging Research Laboratory (WHIRL) in the Department of Obstetrics, Gynecology and Reproductive Sciences.

Conditions

• Fertility

Interventions

DRUG

Letrozole

20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 12 mm in diameter

DRUG

Letrozole

20 mg, one tablet a day for one day, starting on the day the dominant follicle reaches 18 mm in diameter

DRUG

Letrozole

20 mg, one tablet a day for one day, starting 24-48 hours after ovulation of the dominant follicle is observed

DRUG

Letrozole

2.5 mg, one tablet a day for five days, starting 24-48 hours after ovulation of the dominant follicle is observed

DRUG

Letrozole

2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter

DRUG

Letrozole

2.5 mg, one tablet a day for five days, starting on the day the dominant follicle reaches 18 mm in diameter

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• University of Saskatchewan

  lead OTHER

Principal Investigators

• Roger A Pierson, PhD · University of Saskatchewan

• Donna R Chizen, MD · University of Saskatchewan

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2012-02-29

Completion

2012-02-29

Countries

• Canada

Study Locations