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CompletedNCT02302638Updated Jun 9, 2015

Embryo Development Using Two Commercial Single-step Media

An interventional study of embryo culture in different single-step media in Infertility, sponsored by Eugonia. Completed at 1 site in Greece. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-09.

Sponsored by Eugonia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study summary

This prospective study with sibling oocytes will evaluate the efficiency of two commercial single-step media, namely Sage 1-step and Continuous Single Culture Medium (CSCM), in terms of embryo utilization rates, blastocyst formation rates, embryo quality and pregnancy rates. Embryos will be cultured continuously for up to 6 days under identical conditions.

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Conditions studied

  • Infertility

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Keywords

  • single-step media
  • embryo development
  • blastocyst formation
  • embryo utilization
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 43 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Eugonia is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • at least 10 oocytes retrieved

Exclusion criteria

Exclusion Criteria:

  • frozen oocytes
  • testicular biopsy
  • less than 10 oocytes retrieved
  • older than 40 years
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Sage 1-step

    Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in Sage 1-step medium for up to six days following oocyte retrieval.

    Other: embryo culture in different single-step media

  • Active comparator
    CSCM

    Embryo culture in different single-step media: Half of each patient's oocytes will be randomly allocated to be cultured in CSC medium for up to six days following oocyte retrieval.

    Other: embryo culture in different single-step media

Interventions

  • Otherembryo culture in different single-step media

    Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.

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What researchers measure

Primary outcomes

  1. Utilization rates

    Utilization = embryos selected for transfer and cryopreservation

    Time frame: 6 days post oocyte retrieval

  2. Blastocyst formation

    Number of blastocysts on day 5 post oocyte retrieval per fertilized oocytes

    Time frame: 5 days post oocyte retrieval

Secondary outcomes

  1. Embryo quality on day 3

    Time frame: 3 days post oocyte retrieval

  2. blastocyst quality on day 5

    Time frame: 5 days post oocyte retrieval

  3. positive pregnancy test

    Time frame: 15 days post oocyte retrieval

  4. clinical pregnancy

    presence of gestational sac with positive fetal heartbeat

    Time frame: 7 weeks of gestation

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Study locations

1 site
  • Eugonia Assisted Reproduction Unit
    Athens, Attica 11528, Greece
08

References and documents

Publications

  • Sfontouris IA, Kolibianakis EM, Lainas GT, Venetis CA, Petsas GK, Tarlatzis BC, Lainas TG. Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes. J Assist Reprod Genet. 2017 Oct;34(10):1377-1383. doi: 10.1007/s10815-017-0997-0. Epub 2017 Jul 17. PubMed 28718081 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02302638
Lead sponsor
Eugonia
Responsible party
Sponsor
First posted
Nov 27, 2014
Start date
Nov 2014
Primary completion
Jun 2015
Completion
Jun 2015
Last update
Jun 9, 2015

Study contacts

Ioannis A Sfontouris, PhD
principal investigator · Eugonia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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