Administration of Single High Dose Letrozole for Ovulation Induction - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mount Sinai Hospital, Canada
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- number of follicles >15 mm at day of ovulation
Study Overview
Brief Summary
Letrozole is considered an established treatment for ovulation induction.The most common protocol is daily dose of 2.5-7.5 mg starting day 3-5 of the cycle for 5 days.Another described protocol is single high dose 20mg Letrozole given on day 3 of the cycle.
Our aim is to compare the single high dose Letrozole protocol to daily low dose protocol.
Detailed Description
Pre-study screening will be conducted before the enrolment in the study, routine fertility assessment: Physical history including fertility and fertility treatment history. Laboratory tests-cycle day 3 hormonal profile (Estradiol, Luteinizing hormone, Follicular stimulating hormone, progesterone), cycle day 3 antral follicular count.
Pregnancy will be excluded by Human chorionic gonadotropin test at day 3 of the cycle, before starting the fertility treatment.
Polycystic syndrome (PCOS) patients will be defined according to Rotterdam criteria 2003.
A prospective randomized clinical trial. PCOS patients who require induction of ovulation will prospectively randomized into two groups:
- Single 20 mg dose of Letrozole on day 3 of the menstrual cycle. Monitoring for response will include the usual measurements of serum Estradiol (E2), Follicle stimulating hormone (FSH), Luteinizing Hormone (LH), Progesterone (P) and transvaginal ultrasound for follicular count and endometrial thickness measurement. First monitoring will be on day 7 of the cycle and the rest of the monitoring will be determined according to response.
- Daily dose of Letrozole 2.5 mg starting day 3 for 5 days. Monitoring for response will include serum Estradiol (E2), Follicule stimulating hormone (FSH), Luteinizing Hormone (LH ), Progesterone (P) and transvaginal ultrasound for follicular count and endometrial thickness measurement. First day of monitoring will be on day 7 and the rest of monitoring will be determined according to response.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Polycystic ovary syndrome (PCOS) patients
- •BMI (body mass index) of 18-
- •Proved one patent fallopian tube at least
Exclusion Criteria
- •Women with low ovarian response (According to Bologna criteria )
- •Blocked fallopian tubes
- •Pregnancy
- •Presence of any clinically significant health problem such that treatment with letrozole or pregnancy would not be in the subject's best interest.
- •Co-administration of other anti-estrogens
- •Hypersensitivity to Letrozole .
Arms & Interventions
Single dose
Single 20 mg dose of Letrozole on day 3 of the menstrual cycle.
Intervention: Letrozole (Drug)
Daily dose
Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.
Intervention: Letrozole (Drug)
Outcomes
Primary Outcomes
number of follicles >15 mm at day of ovulation
Time Frame: First day of monitoring will be on day 7 and the rest of monitoring will be appointed according to response up to 1month
Secondary Outcomes
- Pregnancy rate(2 months)