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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05677828
Other study ID # CCER 21-22 - 21
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2022
Est. completion date January 31, 2023

Study information

Verified date March 2023
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective study aims to assess the effect of adding letrozole in patients who have previously undergone an IVF cycle with either an antagonist or short protocol, with patients who have undergone a second cycle of IVF with an antagonist or short protocol without the addition of letrozole.


Description:

A limited number of studies suggest that the addition of letrozole to gonadotropins for IVF is associated with an increase in oocyte count, blastocyst count and implantation rate. These differences are presumed to be caused by an increase in intra-ovarian androgens associated with the addition of letrozole. In patients with reduced ovarian reserve or reduced oocyte quality in the previous cycle, supplementation with of letrozole has the potential to increase oocyte count or oocyte quality, thereby resulting in more transferable blastocysts. The antagonist stimulation protocol with the addition of letrozole is commonly referred to as the SMART protocol (Stimulation with Minimal Adverse effects, Retrieval and Transfer


Recruitment information / eligibility

Status Completed
Enrollment 426
Est. completion date January 31, 2023
Est. primary completion date December 12, 2022
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 42 Years
Eligibility Inclusion Criteria for the SMART IVF protocol: - Women between the ages of 20 and 42 inclusively - Women proceeding with a SMART IVF protocol following an antagonist IVF protocol between 2010 and 2020 (study group) or women proceeding with an antagonist protocol following an antagonist IVF protocol between 2010 and 2020 (control group) - Delay of 1 year between both IVF cycle Exclusion Criteria: - Women undergoing fertility preservation - Oocyte donation IVF cycles - Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Clinique Ovo Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of utilizable blastocysts obtained Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used approximately 20 days
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