Comparison of Two Embryo Culture Media for IVF and ICSI

March 9, 2016 updated by: Centre Hospitalier Universitaire Dijon

Comparison of Two Embryo Culture Media for IVF (in Vitro Fertilization) and ICSI ( Intracytoplasmic Sperm Injection ): Randomized Prospective Study

In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1000

Phase

  • Not Applicable

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 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any IVF and IVF with ICSI procedure performed in the unit can be included in the study

Exclusion Criteria:

  • refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: global medium
Biological: global medium
Experimental: SSM
Biological: SSM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of pregnancies and deliveries
Time Frame: Up to 9 months
Up to 9 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Estimate)

March 10, 2016

Last Update Submitted That Met QC Criteria

March 9, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • JIMENEZ 2008

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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