Comparison of Single vs Group Embryo Culture in Micro-well Group Culture Dish

January 30, 2014 updated by: Elif Güler Ergin

Randomized Controlled Comparison of Single Embryo Culture Versus Group Culture Using a Micro-well Group Culture Dish in Humans

Does group culture using micro-well group culture dishes improve human blastocyst development compared to single embryo culture?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

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 Contact

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Eurofertil IVF Health Center
        • Contact:
        • Principal Investigator:
          • Elif Güler Ergin, MD

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 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: female age uner 40, male age under 60 patients undergoing IVF-treatment with oocyte collection after ovarian hyperstimulation having signed the study-specific consent form patient fulfilling clinic's standard criteria for blastocyst culture minimum 5 normally fertilized oocytes at the time of fertilization check

Exclusion Criteria: use of any type of surgically retrieved sperm cells patients undergoing any kind of genetic diagnosis at any developmental stage

-

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
Active Comparator: single embryo culture
single embryo culture in single drops inside micro-well group culture dish
Other: micro-well group culture dish
an embryo culture dish containing nine micro-wells in the middle.
Experimental: group embryo culture
group embryo culture in a single drop inside micro-well group culture dish
Other: micro-well group culture dish
an embryo culture dish containing nine micro-wells in the middle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blastocyst development
Time Frame: 6 days
6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate
Time Frame: 1 month
1 month

Other Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Elif Güler Ergin

Collaborators

Vitrolife

Investigators

  • Principal Investigator: Elif Güler Ergin, MD, Eurofertil IVF Health Center

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

July 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 30, 2014

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WOW-1

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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