Blastocyst Culture in a Time-lapse Incubator

June 10, 2016 updated by: Yasmin, Dar AlMaraa Center

The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator

Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature".

For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos:

  1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
  2. Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3.

Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sunrise Fertility Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female partners were under the age of 39 years
  • Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates

Exclusion Criteria:

  • Day 3 embryo transfer cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Uninterrupted single embryo culture
The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3.
Experimental: Interrupted single medium culture
The single step medium is renewed on Day 3 of embryo culture.
Procedure: Culture media renwal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 4 weeks post embryo transfer
diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound
4 weeks post embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 4-6 weeks post embryo transfer
the number of intrauterine gestational sacs over the total number of embryos transferred
4-6 weeks post embryo transfer
Blastocyst formation rate
Time Frame: 5-6 days post intracytoplasmic sperm injection
5-6 days post intracytoplasmic sperm injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dar AlMaraa Center

Investigators

  • Principal Investigator: Yasmin Magdi, M.Sc, Dar Almaraa fertility and gynacology center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 17, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 006734

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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