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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06290895
Other study ID # 3465
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 22, 2024
Est. completion date February 19, 2025

Study information

Verified date February 2024
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 54
Est. completion date February 19, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
women having had a second IVF cycle with 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.

Locations

Country Name City State
Canada Clinique Ovo Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blastocyst rate Likelihood of an oocyte fertilized to blastocyst stage 5 days after oocyte fertilization
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