Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-08 @ 12:03 AM
Study NCT ID:
NCT01107002
Status:
COMPLETED
Last Update Posted:
2011-07-15
First Post:
2010-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients With Previous In Vitro Fertilization Failure
Sponsor:
Royan Institute
Organization:
Study Overview
Official Title:
Comparison of 5 Day Embryo Transfer With 2-3 Day Transfer in Patients Who Failed to Conceive in Two or More Day 2-3 Embryo Transfer Cycle in Royan Institute
Status:
COMPLETED
Status Verified Date:
2010-04
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:
The purpose of this study is to determine whether embryo transfer on day 3 versus day 5 shows a significant difference in implantation, clinical pregnancy, live birth, miscarriage and multiple pregnancy rates among women with at least two previous IVF failures
Detailed Description:
A total of 200 infertile women with at least two previous IVF failures will enroll in this prospective randomized clinical trial study and will randomly be divided into two groups. Random permuted blocks with a block size of 4 will be used to ensure randomization and complete allocation concealment.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee.
Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.
Main outcome measures will be implantation, clinical pregnancy and live birth rates.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee.
Ovarian stimulation protocol will include the use of a GnRH agonist (Superfact; Aventis Pharma Deutshlan, Frankfurt, Germany) administered in the long (down-regulation) protocol and the subsequent addition of FSH (Gonal F, Sereno, Switzerland). Embryos will be initially cultured in G1.V5 medium) Vitrolife-Sweden)TM on day 1 and 2, being transferred from this medium to G2.V5 ) Vitrolife-Sweden)TM on day 3. Embryos will be transferred on day 5, depending on the degree of expansion of the blastocyst.
Main outcome measures will be implantation, clinical pregnancy and live birth rates.
Study Oversight
Has Oversight DMC:
True
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?: