A Phase 4 interventional study of Letrozole in Anovulation, sponsored by Mount Sinai Hospital, Canada. Completed at 2 sites in Canada. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-17.
Sponsored by Mount Sinai Hospital, Canada · Phase 4, Interventional, and Treatment
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.
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:
Statistical 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.
75 studies on the registry are indexed under Anovulation; 7 are open to participants now.
This study's enrollment of 36 is below the median of 80 across 52 interventional studies indexed under Anovulation.
Browse Anovulation studies →Mount Sinai Hospital, Canada is the lead sponsor of 158 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single 20 mg dose of Letrozole on day 3 of the menstrual cycle.
Drug: Letrozole
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.
Also known as: Femara
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
Pregnancy rate
Time frame: 2 months
Plan to share: No
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Letrozole
Mount Sinai Hospital, Canada →