Infertility Clinical Trial
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
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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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