Clinical Trial: Administration of Single High Dose Letrozole for Ovulation Induction
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Administration of Single High Dose Letrozole for Ovulation Induction - A Randomized Controlled Trial
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 Summary:
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.
Statistical Analysis
- Prim
Sponsor: Mount Sinai Hospital, Canada
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Pregnancy rate [ Time Frame: 2 months ]
Original Secondary Outcome: Same as current
Information By: Mount Sinai Hospital, Canada
Dates:
Date Received: March 3, 2016
Date Started: March 2016
Date Completion: July 2018
Last Updated: June 15, 2016
Last Verified: March 2016
