Embryo Development Using Two Commercial Single-step Media

June 8, 2015 updated by: Eugonia

Embryo Development and Utilization Using Two Commercial Single-step Media

This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

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:

  • at least 10 oocytes retrieved

Exclusion Criteria:

  • frozen oocytes
  • testicular biopsy
  • less than 10 oocytes retrieved
  • older than 40 years

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sage 1-step

Embryo culture in different single-step media:

Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval.
Other: embryo culture in different single-step media
Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.
Active Comparator: CSCM

Embryo culture in different single-step media:

Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval.
Other: embryo culture in different single-step media
Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utilization rates
Time Frame: 6 days post oocyte retrieval
Utilization = embryos selected for transfer and cryopreservation
6 days post oocyte retrieval
Blastocyst formation
Time Frame: 5 days post oocyte retrieval
Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes
5 days post oocyte retrieval

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embryo quality on day 3
Time Frame: 3 days post oocyte retrieval
3 days post oocyte retrieval
blastocyst quality on day 5
Time Frame: 5 days post oocyte retrieval
5 days post oocyte retrieval
positive pregnancy test
Time Frame: 15 days post oocyte retrieval
15 days post oocyte retrieval
clinical pregnancy
Time Frame: 7 weeks of gestation
presence of gestational sac with positive fetal heartbeat
7 weeks of gestation

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

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

November 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 26, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sage vs CSCM

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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