CClinicalTrials.gg
CompletedNCT05677828Updated Mar 29, 2023

SMART Protocol vs Antagonist Protocol in IVF

An observational study in Diminished Ovarian Reserve, sponsored by Clinique Ovo. Completed at 1 site in Canada. Open to female participants aged 20 Years to 42 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by Clinique Ovo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
426
Ages
20 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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

02

Conditions studied

  • Diminished Ovarian Reserve

Keywords

  • IVF
  • Fertility issues
03

In context

Lead sponsor

Clinique Ovo is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This retrospective cohort study will analyze IVF cycles in antagonist and SMART stimulation protocols during the period from 2010 to 2020.

Inclusion criteria

  • 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

Exclusion Criteria:

  • Women undergoing fertility preservation
  • Oocyte donation IVF cycles
  • Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
426 participants (actual)
Patient registry
No

Groups and cohorts

  • Antagonist - SMART

    Women who have had a SMART IVF stimulation cycle with Letrozole after a failed antagonist IVF stimulation cycle between 2010 and 2020.

  • Antagonist - Antagonist

    Women who have had an antagonist stimulation IVF cycle after a previously failed antagonist IVF stimulation cycle between 2010 and 2020.

06

What researchers measure

Primary outcomes

  1. Number of utilizable blastocysts obtained

    Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used

    Time frame: approximately 20 days

07

Study locations

1 site
  • Clinique Ovo
    Montreal, Quebec H4P 2S4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05677828
Lead sponsor
Clinique Ovo
Responsible party
Sponsor
First posted
Jan 10, 2023
Start date
Feb 15, 2022
Primary completion
Dec 12, 2022
Completion
Jan 31, 2023
Last update
Mar 29, 2023

Study contacts

Robert Hemmings, MD
principal investigator · Clinique Ovo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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