Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates

December 15, 2014 updated by: Eugonia

Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

The current study will include 2 RCTs:

RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.

RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.

Study Type

Interventional

Enrollment (Actual)

131

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

  • Greece
    • Attica
      • Athens, Attica, Greece, 11528
        • Eugonia Assisted Reproduction Unit

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • <40 years of age
  • female infertility patients
  • at least 10 retrieved oocytes

Exclusion Criteria:

  • 41 years or older
  • frozen-thawed oocytes/embryos
  • oocyte donation 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Global
In vitro embryo culture in single-step medium (Global)
Other: Global
Single medium for the culture of embryos from Day1 to Day 5
Other Names:
  • Global medium (LIfeGlobal)
Active Comparator: Origio
In vitro embryo culture in sequential media (Origio)
Other: Origio
Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)
Other Names:
  • ISM1/BlastAssist (Origio)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate per embryo transferred
Time Frame: 7 weeks
Number of fetal sacs with positive heart beat at 7 weeks of gestation
7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst formation rate
Time Frame: Day 5
Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval
Day 5
Good quality blastocysts
Time Frame: Day 5
Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively.
Day 5
Positive hCG rates
Time Frame: 14 days
Pregnancy test as assessed by detection of hCG using blood test
14 days
Ongoing pregnancy rates
Time Frame: 12 weeks
Pregnancy reaching 12 weeks of gestation
12 weeks
Early pregnancy loss
Time Frame: 12 weeks
Miscarriage per positive hCG test up to 12 weeks of gestation
12 weeks
Clinical pregnancy
Time Frame: 7 weeks
Pregnancy reaching 7 weeks of gestation
7 weeks

Collaborators and Investigators

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

Sponsor

Eugonia

Investigators

  • Principal Investigator: Ioannis A Sfontouris, PhD, Eugonia
  • Study Director: Trifon G Lainas, PhD, Eugonia

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

January 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 29, 2014

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Global versus Origio

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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