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NCT Number: NCT02048527

Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eugonia Assisted Reproduction Unit

Athens, Attica, 11528, Greece

About this study

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

The current study will include 2 RCTs:

RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.

RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <40 years of age
  • female infertility patients
  • at least 10 retrieved oocytes

Exclusion criteria

  • 41 years or older
  • frozen-thawed oocytes/embryos
  • oocyte donation cycles

Treatment and study plan

Global

Other

Single medium for the culture of embryos from Day1 to Day 5

Other names: Global medium (LIfeGlobal)

Origio

Other

Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)

Other names: ISM1/BlastAssist (Origio)

Primary outcomes

  1. Implantation rate per embryo transferred

    Time frame: 7 weeks

    Number of fetal sacs with positive heart beat at 7 weeks of gestation

Secondary outcomes

  1. Blastocyst formation rate

    Time frame: Day 5

    Embryos reaching the blastocyst stage on Day 5 post oocyte retrieval

  2. Good quality blastocysts

    Time frame: Day 5

    Good quality blastocysts are considered at least full blastocysts (stage 3 and above) with grade A or grade B inner-cell mass and trophectoderm respectively.

  3. Positive hCG rates

    Time frame: 14 days

    Pregnancy test as assessed by detection of hCG using blood test

  4. Ongoing pregnancy rates

    Time frame: 12 weeks

    Pregnancy reaching 12 weeks of gestation

  5. Early pregnancy loss

    Time frame: 12 weeks

    Miscarriage per positive hCG test up to 12 weeks of gestation

  6. Clinical pregnancy

    Time frame: 7 weeks

    Pregnancy reaching 7 weeks of gestation

Sponsors and collaborators

Lead sponsor

Eugonia

Other

Registry information

Official study title

Comparison of Single-step (Global) Versus Sequential Media (Origio) in Preimplantation Embryo Development and Pregnancy Rates

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 29, 2014
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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