SMART Protocol vs Antagonist Protocol in IVF

Sponsor

Clinique Ovo (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05677828

Collaborator

(none)

3,600

Enrollment

Location

11.5

Anticipated Duration (Months)

313.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diminished Ovarian Reserve

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

3600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Feb 15, 2022

Actual Primary Completion Date :

Dec 12, 2022

Anticipated Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Number of utilizable blastocysts obtained [approximately 20 days]
Comparing 2 different IVF cycle protocols in terms of total dose of gonadotropins used

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 42 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Ovo	Montreal	Quebec	Canada	H4P 2S4

Sponsors and Collaborators

Clinique Ovo

Investigators

Principal Investigator: Robert Hemmings, MD, Clinique Ovo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinique Ovo

ClinicalTrials.gov Identifier:

NCT05677828

Other Study ID Numbers:

CCER 21-22 - 21

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Clinique Ovo

IVF

Fertility issues

Study Results

No Results Posted as of Jan 10, 2023