NCT05677828

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
426

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

10 months

First QC Date

December 22, 2022

Last Update Submit

March 27, 2023

Conditions

Diminished Ovarian Reserve

Keywords

IVFFertility issues

Outcome Measures

Primary Outcomes (1)

  • Number of utilizable blastocysts obtained

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

    approximately 20 days

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Robert Hemmings, MD

    Clinique Ovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 10, 2023

Study Start

February 15, 2022

Primary Completion

December 12, 2022

Study Completion

January 31, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

CA(1)