SMART Protocol vs Antagonist Protocol in IVF

Diminished Ovarian Reserve Clinical Trial

Official title:

Effect of the Addition of Letrozole in in Vitro Fertilization (IVF) Following a Prior Failed IVF Cycle With an Antagonist or Short Protocol Without Letrozole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05677828
• Other study ID #: CCER 21-22 - 21
• Status: Completed
• 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
• 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)

Related Conditions & MeSH terms

• Diminished Ovarian Reserve

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