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OpenTrials
Completed

NCT Number: NCT05677828

SMART Protocol vs Antagonist Protocol in IVF

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.

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Key information

Conditions

Diminished Ovarian Reserve Genital Diseases Infertility Urogenital Diseases

Age range

20 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of utilizable blastocysts obtained

    Time frame: approximately 20 days

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

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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