NCT06290895

Brief Summary

Studies reported that calcium signal deficiency or insufficiency during oocyte activation are related with embryo arrest and blastocyst quality. The utilization of Artificial Oocyte Activation (AOA) is safe and does not increase birth defects, cognition, language and motor skills. AOA is the first line of treatment in patients with globozoospermia (round headed spermatozoa). Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists and comprises about 10-15% of patients undergoing controlled ovarian hyperstimulation. The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. The European Society of Human and REproduction (ESHRE) recommends AOA in cases with failed fertilization/ low fertilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 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
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 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)

  • Blastocyst rate

    Likelihood of an oocyte fertilized to blastocyst stage

    5 days after oocyte fertilization

Study Arms (2)

In-vitro fertilization (IVF) cycle using artificial oocyte activation (AOA)

Other: women having had a second IVF cycle with AOA

In-vitro fertilization (IVF) cycle without artificial oocyte activation (AOA)

Interventions

The absence of synergy between the oocyte and sperm leads to a negative impact on oocyte activation. Physiological oocyte activation requires a sperm-derived enzyme called phospholipase C zeta to cause the release of calcium in the form of oscillations from internal storages.

In-vitro fertilization (IVF) cycle using artificial oocyte activation (AOA)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen able to have oocyte retrieval after in-vitro fertilization
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Data spreadsheet from 2018 to 2023 of patients having undergone an IVF cycle

You may qualify if:

  • Patients with poor or no blastocyst development in their primary cycle
  • Group 1 - second cycle using AOA following the poor blastocyst development cycle
  • Group 2 - second cycle without AOA following the poor development cycle

You may not qualify if:

  • All cycles who do not have repeat cycles following the poor blastocyst development cycle

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

  • Simon Phillips, PhD

    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

March 26, 2024

Study Completion

March 26, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations