SMART Protocol vs Antagonist Protocol in IVF

NCT ID: NCT05677828

Last Updated: 2023-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

426 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-01-31

Brief Summary

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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

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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

Conditions

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Diminished Ovarian Reserve

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Antagonist - SMART

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

No interventions assigned to this group

Antagonist - Antagonist

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

No interventions assigned to this group

Eligibility Criteria

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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

* Women undergoing fertility preservation
* Oocyte donation IVF cycles
* Diagnosed severe male factor requiring surgical sperm extraction (micro-tese or TESA)
Minimum Eligible Age

20 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Hemmings, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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CCER 21-22 - 21

Identifier Type: -

Identifier Source: org_study_id

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