PGTai Results for Embryos Cultured in Sequential Versus Single Step Media

NCT ID: NCT04485910

Last Updated: 2020-07-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2021-06-01

Brief Summary

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A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Detailed Description

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Purpose:

To evaluate PGTai results for embryos cultured in sequential versus single step media.

Method:

Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).

All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.

Conditions

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Infertility Aneuploidy Rate Mosaicism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single step media

Embryos cultured in single step media

Group Type ACTIVE_COMPARATOR

Single step media

Intervention Type OTHER

Usage of single step media in embryo culture

Sequential media

Embryos cultured in sequential media

Group Type ACTIVE_COMPARATOR

Sequential media

Intervention Type OTHER

Usage of sequential media in embryo culture

Interventions

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Single step media

Usage of single step media in embryo culture

Intervention Type OTHER

Sequential media

Usage of sequential media in embryo culture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female age ≤37 years with ≥ 8 mature oocytes
* Male partner had normal semen parameters according to WHO 2010
* PGT-A was done at the blastocyst stage

Exclusion Criteria

* sperm or oocyte donor
* severe male factors according to WHO 2010
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganin Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manar M Hozyen, MSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Amr Elshimy, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hanaa Elkhader, BSc.

Role: PRINCIPAL_INVESTIGATOR

Ganin Fertility Center

Hosam Zaki, MSc.

Role: STUDY_CHAIR

Ganin Fertility Center

Locations

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Ganin Fertility Center

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Manar M Hozyen, MSc.

Role: CONTACT

+201229483320

Amr Elshimy, BSc.

Role: CONTACT

Other Identifiers

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MH0004

Identifier Type: -

Identifier Source: org_study_id

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