- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06290895
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
Conditions
Intervention / Treatment
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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