NCT06290921

Brief Summary

Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2024

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 22, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2024

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

February 26, 2024

Last Update Submit

March 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rate

    clinical pregnancy is the presence of fetal heartbeat at the viability ultrasound

    6 to 8 weeks after Frozen Embryo Transfer

Interventions

Ovulation triggering when women only 2 dominant follicles as opposed to the clinic's standard of 3 follicles or more

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen able to have an embryo transfered in their uterus
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Data spreadsheet from 2011 to 2017 of patients having undergone an IVF cycle

You may qualify if:

  • Stimulated IVF cycle at clinique ovo
  • Patients with a maximum of 3 mature follicles (≥14mm) on the day of ovulation trigger

You may not qualify if:

  • Cycle cancelation due to no follicles
  • History of recurrent implantation failure
  • Contraindication of ovulation induction medication

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

  • Louise Lapensée, 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

February 26, 2024

First Posted

March 4, 2024

Study Start

February 22, 2024

Primary Completion

April 1, 2024

Study Completion

June 11, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations