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Administration of Single High Dose Letrozole for Ovulation Induction

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ClinicalTrials.gov Identifier: NCT02703649
Recruitment Status : Unknown
Verified March 2016 by Mount Sinai Hospital, Canada.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.


Condition or disease Intervention/treatment Phase
Anovulation Drug: Letrozole Phase 4

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:

  1. 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.
  2. 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

  • Primary Endpoint Analysis: Sample Size Selection In order to prove non-inferiority with significance level (alpha) 5% and power of 90%, standard deviation of outcome 1, and noninferiority limit 1; the sample size needed is 36 patients in both groups. Calculation based on Jolious SA formula.(7)
  • Planned Analysis

Primary Outcome Analysis:

Comparison of the number of follicle >15 mm at day of ovulation

Secondary Outcome Analysis:

Pregnancy rate Comparison between the two groups Estradiol levels at day of ovulation triggering Ovarian hyperstimulation syndrome Clinical pregnancy rate

Statistical analysis :

The various outcome measures will be expressed as numbers and rates. The Student t test, χ2 test and analysis of variance will be used where appropriate to analyze the various data among the study groups. P value less than .05 will be considered statistically significant.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Single High Dose Letrozole for Ovulation Induction - A Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Single dose
Single 20 mg dose of Letrozole on day 3 of the menstrual cycle.
Drug: Letrozole
After the decision to use Letrozole for induction of ovulation, we will obtain informed consent and randomize the patents into 2 groups Single 20 mg dose of Letrozole on day 3 of the cycle Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.
Other Name: Femara

Active Comparator: Daily dose
Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.
Drug: Letrozole
After the decision to use Letrozole for induction of ovulation, we will obtain informed consent and randomize the patents into 2 groups Single 20 mg dose of Letrozole on day 3 of the cycle Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.
Other Name: Femara




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pregnancy rate [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Polycystic ovary syndrome (PCOS) patients
  • BMI (body mass index) of 18-35.
  • 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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703649


Contacts
Contact: Robert Casper, MD +1 416 972-0110 casper@lunenfeld.ca
Contact: Nivin Samara, MD +1 416 972-0110 nivin5ss@yahoo.com

Locations
Canada, Ontario
Mount Sinai Hospital, University of Toronto Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Robert Casper, MD    416-972-0110    casper@lunenfeld.ca   
Principal Investigator: Robert Casper, MD         
Sub-Investigator: Nivin Samara, MD         
TRIO Fertility Enrolling by invitation
Toronto, Ontario, Canada, M5G 2K4
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Principal Investigator: Robert Casper, MD University of Toronto

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02703649     History of Changes
Other Study ID Numbers: Siba0101
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mount Sinai Hospital, Canada:
Aromatase inhibitor
induction of ovulation

Additional relevant MeSH terms:
Anovulation
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs