Time-lapse Evaluation of Human Embryo Development in Single Versus Sequential Culture Media - a Sibling Oocyte Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01507883|
Recruitment Status : Unknown
Verified January 2012 by H. NADIR CIRAY, Bahceci Health Group.
Recruitment status was: Recruiting
First Posted : January 11, 2012
Last Update Posted : January 11, 2012
|Condition or disease|
Maintaining optimal embryo development during in vitro culture is a key element in assisted reproduction treatments. Whether the concept of mimicking in vivo environment is a 'must' in order not to compromise outcome is a matter of debate since 'let the embryo choose' strategy has been shown to perform at least as good as the 'back to nature' in several studies.'Let the embryo choose" approach utilizes a milieu with relatively constant concentration of ingredients (single culture system) as compared to the latter, in which demands of the embryos are supported according to their passage from the Fallopian tubes to the uterus in a sequential culture media. Basic differences between these ingredients are; presence of (1) glucose instead of pyruvate, and (2) essential aminoacids in early embryo stages (until day 3) in single step media, and (3) presence of EDTA in sequential media.
Vast majority of these results were obtained from studies where patients have been randomized into groups instead of employing a sibling (oocyte/embryo) model which could have enabled each patient to serve as her own control. In fact, it has been claimed that introducing a sibling oocyte study design could give a methodological problem at the time of fertilization since different type of culture media vary in osmolarity. Likewise the only study that employed a sibling oocyte model utilized two different media (home-made versus G1.2/G1.2) although the osmolarity of the former had been adjusted to 280-285 mOsm). This study reported no significant differences in day3/5 embryo development as well as pregnancy/implantation rates between groups.
Subsequent studies, however, favoured single step media, as they found higher proportion of compacted embryos to zygotes at day3, morula at 4, a higher blastocyst yield, an overall higher utilization rate after day5 and an improved implantation rate when compared to sequential media. Yet, besides potential variation of gamete qualities between patients allocated to groups (as described above), differences in static observation times of embryos between laboratories could have affected the results in these studies. Current introduction of time-lapse equipment into human assisted reproduction technology enabled a more distinct definition of embryo development and it is now possible to quantify pace of embryo cleavage in various media. Such a definition is also useful to determine the predictive value of embryo development in pre-defined time points will be applicable to all embryology laboratories using various culture systems.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Observational Model:||Case Control|
|Official Title:||Time-lapse Evaluation of Human Embryo Development in Single Versus Sequential Culture Media - a Sibling Oocyte Study|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||January 2012|
Sibling oocytes cultured in single or sequential media until day6
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507883
|Bahceci Fulya IVF Clinic||Recruiting|
|Contact: Nadir Ciray, MD., PhD +90 2123103100|
|Sub-Investigator: Mustafa Bahceci, MD|
|Principal Investigator:||Nadir H Ciray, MD., PhD||Bahceci Health Group|
|Study Chair:||Turan Aksoy, BS||Bahceci Health Group|
|Study Director:||Mustafa Bahceci, MD||Bahceci Health Group|
|Study Chair:||Cihan Goktas, BS||Bahceci Health Group|
|Study Chair:||Birgen Ozturk, BS||Bahceci Health Group|