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SMART Protocol vs Antagonist Protocol in IVF

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05677828
Enrollment
426
Registered
2023-01-10
Start date
2022-02-15
Completion date
2023-01-31
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diminished Ovarian Reserve

Keywords

IVF, Fertility issues

Brief 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.

Detailed 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

Interventions

None listed

Sponsors

Clinique Ovo
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 42 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of utilizable blastocysts obtainedapproximately 20 daysComparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026