Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor

NCT ID: NCT02418416

Last Updated: 2018-09-27

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-06

Study Completion Date

2016-06-30

Brief Summary

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Novel approach for Oocyte fertilization failure for difficult cases not respond to traditional methods of assisted reproduction as intracytoplasmic sperm injection.

Detailed Description

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In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors recommend chemical activation for those group of patient with Ca ionophore but still with Ca ionophore there are some cases with total fertilization failure or low fertilization specially in those patient with 2 separate factors like teratozoospermia with poor quality Oocytes so the investigators decided to test the effect of double activation methods by using tow agents proven with life birth rate Ca ionophore and strontium chloride.

We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore followed by strontium chloride activation and monitoring the embryogenesis until the blastocyst formation and pregnancy outcome in multicenter assessment.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Double activation

The Oocytes in this arm will undergo double activation with Ca ionophore 5 micro mol for 20 min them Strontium chloride 10 micro mol for 60 min.

Group Type EXPERIMENTAL

Oocyte double chemical activation

Intervention Type OTHER

Oocyte double chemical activation

Control arm

The Oocytes will undergo Intracytoplasmic sperm injection only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oocyte double chemical activation

Oocyte double chemical activation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* poor sperm
* poor quality Oocytes
* previous failed fertilization
* previous poor embryogenesis

Exclusion Criteria

* normal patient
* previous successful outcome
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 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 Laboratory Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Barka fertility center

Bahrain, , Bahrain

Site Status

Banon fertility center

Asyut, , Egypt

Site Status

IbnSina IVF unit, IbnSina Hospital, El Areef Square

Sohag, , Egypt

Site Status

Countries

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Bahrain Egypt

Other Identifiers

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IbnSina Hospital IVF

Identifier Type: -

Identifier Source: org_study_id

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