Administration of Single High Dose Letrozole for Ovulation Induction

NCT02703649 | Completed Phase 4 DMC

• 1 other identifier: Siba0101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Anovulation

Keywords

Aromatase inhibitor; induction of ovulation

Outcome Measures

Primary Outcomes (1)

• number of follicles >15 mm at day of ovulation

  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 (1)

• Pregnancy rate

  2 months

Study Arms (2)

Single dose

EXPERIMENTAL

Single 20 mg dose of Letrozole on day 3 of the menstrual cycle.

Drug: Letrozole

Daily dose

ACTIVE COMPARATOR

Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.

Drug: Letrozole

Interventions

Letrozole DRUG

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

Daily dose; Single dose

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (PCOS) patients
• BMI (body mass index) of 18-35.
• Proved one patent fallopian tube at least

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (2)

Mount Sinai Hospital, University of Toronto

Toronto, Ontario, M5G 1X5, Canada

Location

TRIO Fertility

Toronto, Ontario, M5G 2K4, Canada

Location

Related Publications (1)

• Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.

  PMID: 36165742 DERIVED

MeSH Terms

Conditions

Anovulation

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert Casper, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)