Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01689428
Status:
UNKNOWN
Last Update Posted:
2012-09-21
First Post:
2012-09-10
Brief Title:
Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases
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 Pregnancy Loss
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 miscarriage andor biochemical pregnancy 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
The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25 of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium As secondary outcome the investigators will assume a 5 of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium
Couples requiring IVF treatment and with a past experience of miscarriage andor biochemical pregnancy 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
The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25 of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium As secondary outcome the investigators will assume a 5 of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium
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 |
|---|---|---|---|
| EG1 | OTHER | Biogenesi Reproductive Medicine Centre | None |