Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate

Brief Title

A Time-lapse Monitoring Prospective Study

Official Title

Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate: A Time-lapse Monitoring Prospective Study

Brief Summary

      While numerous types of commercially available human embryo culture media exist for human
      blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy
      formation is not fully understood. Culture conditions are very important for the success of
      the in vitro fertilization (IVF) cycle, many of the factors involved in the process have been
      extensively studied. However, none of the studies investigated the effect on euploid rate in
      a sibling oocyte design with preimplantation genetic testing for aneuploidy (PGT-A), which
      requires culture till day 7. In addition, the clinical outcome (implantation) will be
      investigated in a frozen cycle regimen. Hence, the study will explore which day of media
      refreshment will result in higher rate of ploidy and would improve clinical outcomes.
      Investigators aim at exploring the best practice, that would empower the euploid rate through
      the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte
      prospective design.
    

Detailed Description

      The use of extended embryo culture to the blastocyst stage and PGT-A has enabled
      identification and selection of embryos with the best developmental potential and improved
      IVF clinical outcomes. It is considered a routine practice to grade the embryos on day 3 of
      development, which will require disturbing the culture conditions by annotating the embryos
      using inverted microscopes. However, the application of Time-lapse technology (TLS) allows
      annotating the embryos on day 3 without interrupting the culture conditions, especially if
      TLS is combined with single-step culture medium.

      There are several culture factors that can affect embryo development, such as the pH, which
      is controlled through the concentration of CO2, and also the osmolality, which is the
      concentration of solute per liter of solution. Evaporation of the solution due to the
      exposure to high temperature (37°C) can change the concentrations and hence compromise embryo
      development.

      Since single-step medium is designed to sustain embryo development for 5 continuous culture
      days, while some laboratories culture embryos for 7 days, refreshing the culture medium is
      inevitable either on day 3 or day 5 of development.

      There is no concrete evidence on which of these practices will provide a better environment
      for embryo development. Moreover, none of the studies investigated the effect of single-step
      culture medium changeover on day 3 or day 5, on the chromosomal errors (aneuploidy). We aim
      in this study to explore which day of culture medium refreshment (day 3 or day 5) provides a
      higher rate of euploid blastocysts.

      Summary about data collected. Categorical data will be presented in frequency tables and
      histograms. Continuous values will be summarized according the mean, standard deviation and
      confidence interval.
    


Study Type

Observational [Patient Registry]


Primary Outcome

blastocyst ploidy

Secondary Outcome

 cycle ploidy rate

Condition

Aneuploidy

Intervention

media refreshment

Study Arms / Comparison Groups

 day 3
Description:  embryo grading and culture refreshment will be done 67-69 hours post insemination

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

50

Start Date

July 6, 2021

Completion Date

December 30, 2021

Primary Completion Date

November 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with a minimum of 8 - 10 follicles during ovarian stimulation

          -  Patients with a minimum of 8 mature oocytes

          -  PGT-A

          -  ICSI

          -  BMI<35

          -  Age 18- 40

          -  Fresh or frozen ejaculatory sperm >10,000 motile sperm

          -  Any Ovarian stimulation

          -  Embryos cultured in Time-lapse system

        Exclusion Criteria:

          -  PGT-M or PGT-SR

          -  Previous history of embryo arrest

          -  Endometriosis

          -  Hydrosalpinx

          -  History of uterine abnormality or previous uterine surgery

          -  History of previous treatment which may impact the ovarian reserve (adnexal surgery,
             chemotherapy, radiation…)
      

Gender

Female

Ages

18 Years - 40 Years


Contacts

IBRAHIM ELKHATIB, 97126528000, [email protected]

Location Countries

United Arab Emirates

Location Countries

United Arab Emirates

Administrative Informations


NCT ID

NCT04901247

Organization ID

2103-ABU-003-IK


Responsible Party

Principal Investigator

Study Sponsor

ART Fertility Clinics LLC


Study Sponsor

IBRAHIM ELKHATIB, Principal Investigator, ART Fertility Clinics LLC


Verification Date

September 2021