Viewing Study NCT01689454



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Last Modification Date: 2024-10-26 @ 10:56 AM
Study NCT ID: NCT01689454
Status: UNKNOWN
Last Update Posted: 2012-09-21
First Post: 2012-09-10

Brief Title: ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments
Sponsor: Biogenesi
Organization: Biogenesi

Study Overview

Official Title: Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Implantation Failure
Status: UNKNOWN
Status Verified Date: 2012-09
Last Known Status: ENROLLING_BY_INVITATION
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: Recently it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss

Couples requiring IVF treatment and with a past experience of implantation failure will be included in the study

Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection Fertilized eggs will be cultured in 6 CO2 5 O2 89 N2 atmosphere in microdrops In the treatment group EmbryoGen culture medium EG Origio Måløv Denmark will be adopted throughout the culture period In the control group inseminated oocytes will be cultured in standard culture conditions ie IMS1 medium ISM1 Origio Måløv Denmark maintaining unchanged all other culture conditions

Procedures of embryo transfer will be carried out on day 2 using EmbryoGen or ISM1 respectively The endometrial support will be the same in the two groups
Detailed Description: None

Study Oversight

Has Oversight DMC: None
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?: None
Secondary IDs
Secondary ID Type Domain Link
EG2 OTHER Biogenesi Reproductive Medicine Centre None