Artificial Oocyte Activation

February 26, 2024 updated by: Clinique Ovo

The Effect of Artificial Oocyte Activation on Blastocysts Rate in Patients With Low Fertilization Rate

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.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Quebec
      • Montréal, Quebec, Canada, H4P 2S4
        • Clinique OVO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
In-vitro fertilization (IVF) cycle using artificial oocyte activation (AOA)
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 without artificial oocyte activation (AOA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst rate
Time Frame: 5 days after oocyte fertilization
Likelihood of an oocyte fertilized to blastocyst stage
5 days after oocyte fertilization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Simon Phillips, PhD, Clinique OVO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 19, 2025

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3465

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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