Artificial Oocyte Activation

NCT ID: NCT06290895

Last Updated: 2025-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-22

Study Completion Date

2024-03-26

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Ovarian Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

women having had a second IVF cycle with AOA

Intervention Type OTHER

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)

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Phillips, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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3465

Identifier Type: -

Identifier Source: org_study_id

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