Viewing Study NCT02048527


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Study NCT ID: NCT02048527
Status: COMPLETED
Last Update Posted: 2014-12-16
First Post: 2014-01-27
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates
Sponsor: Eugonia
Organization:

Study Overview

Official Title: Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates
Status: COMPLETED
Status Verified Date: 2014-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: