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. 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
Information provided by (Responsible Party):
H. NADIR CIRAY, Bahceci Health Group

Brief Summary:
Current human IVF technology employs two strategies with respective culture media for embryo development; 'let the embryo choose' (utilizes single step media) and 'back-to-nature' (utilizes sequential media). To our knowledge, there is not any sibling oocyte study to evaluate potential advantages/disadvantages of these strategies on one another.

Condition or disease
In-vitro Fertilization

Detailed Description:

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
Time Perspective: Prospective
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

human oocytes/embryos
Sibling oocytes cultured in single or sequential media until day6

Biospecimen Retention:   Samples With DNA
Human embryos

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women who had undergone infertility treatment and oocytes subjected to ICSI

Inclusion Criteria:

  • Cycles which have gone through egg retrieval procedure between March to November 2011 were included into the study.There was no restriction on the number of previous trials and/or sperm source.

Exclusion Criteria:

  • The maximum number of retrieved oocytes was restricted to 12 and the minimum to 2, as the former was the capacity of one dish (EmbryoSlide™) in which oocytes/embryos could be placed and the latter was the minimum number to be able to make a comparison between groups. Women who were older than 40 years of age were excluded in order to minimize the impact of increased risk of aneuploidy on the results.
  • Cycles in which oocytes/embryos have been subjected to biopsy were also excluded due to the potential risk of delayed embryo development in such cases (Kirkegaard et al., 2011).
  • Furthermore, cycles in which diagnosis of infertility was endometrial factor were not included since such aetiology could negatively affect implantation despite good embryo development.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01507883

Bahceci Fulya IVF Clinic Recruiting
Istanbul, Turkey
Contact: Nadir Ciray, MD., PhD    +90 2123103100      
Sub-Investigator: Mustafa Bahceci, MD         
Sponsors and Collaborators
Bahceci Health Group
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

Responsible Party: H. NADIR CIRAY, Associate Professor, MD., PhD, Bahceci Health Group Identifier: NCT01507883     History of Changes
Other Study ID Numbers: BHC1
First Posted: January 11, 2012    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by H. NADIR CIRAY, Bahceci Health Group: