Artificial Oocyte Activation Comparing Tow Different Agents

NCT ID: NCT02424214

Last Updated: 2018-02-19

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

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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Comparing the efficacy of tow factors for artificial Oocyte Activation for poor quality Oocytes and Teratozoospermia patients.

Detailed Description

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The IVF outcome had been varied widely with a good portion of total fertilization failure even after the most advanced procedure for this group of patient Intracytoplasmic Sperm Injection, many factors that had been tested for assisting the failed group of patient to be fertilized artificially like Ca Ionophore, Strontium Chloride and others but we decide to compare the clinically proven factors for the efficacy and safety in a well randomized clinical trial and monitor the embryogenesis and pregnancy within the 2 groups.

Conditions

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Oocyte Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ca Ionophore group

Artificial Oocyte activation with Ca Ionophore for 20 min after Intracytoplasmic Sperm Injection

Group Type EXPERIMENTAL

Artificial Oocyte activation

Intervention Type OTHER

Ca Ionophore

Intervention Type DRUG

Strontium Chloride group

Artificial Oocyte activation with Strontium Chloride for 60 min after Intracytoplasmic Sperm Injection

Group Type EXPERIMENTAL

Artificial Oocyte activation

Intervention Type OTHER

Strontium Chloride

Intervention Type DRUG

Only Intracytoplasmic Sperm Injection

after Intracytoplasmic Sperm Injection Oocytes will cultured and incubated

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Artificial Oocyte activation

Intervention Type OTHER

Ca Ionophore

Intervention Type DRUG

Strontium Chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* previous fertilization failure
* poor quality Oocytes
* poor sperms

Exclusion Criteria

* normal patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Al Baraka Fertility Hospital

OTHER

Sponsor Role collaborator

Banon IVF Center Assiut, Egypt

OTHER

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Barka fertility center

Manama, , Bahrain

Site Status

Banon Fertility Center

Asyut, , Egypt

Site Status

Ibnsina IVF center

Sohag, , Egypt

Site Status

Countries

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Bahrain Egypt

References

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Fawzy M, Emad M, Mahran A, Sabry M, Fetih AN, Abdelghafar H, Rasheed S. Artificial oocyte activation with SrCl2 or calcimycin after ICSI improves clinical and embryological outcomes compared with ICSI alone: results of a randomized clinical trial. Hum Reprod. 2018 Sep 1;33(9):1636-1644. doi: 10.1093/humrep/dey258.

Reference Type DERIVED
PMID: 30099496 (View on PubMed)

Other Identifiers

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IbnSina Oocyte activation

Identifier Type: -

Identifier Source: org_study_id

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