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Completed

NCT Number: NCT02302638

Embryo Development Using Two Commercial Single-step Media

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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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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least 10 oocytes retrieved

Exclusion criteria

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

Treatment and study plan

embryo culture in different single-step media

Other

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.

Primary outcomes

  1. Utilization rates

    Time frame: 6 days post oocyte retrieval

    Utilization = embryos selected for transfer and cryopreservation

  2. Blastocyst formation

    Time frame: 5 days post oocyte retrieval

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

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

    Time frame: 7 weeks of gestation

    presence of gestational sac with positive fetal heartbeat

Sponsors and collaborators

Lead sponsor

Eugonia

Other

Registry information

Official study title

Embryo Development and Utilization Using Two Commercial Single-step Media

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2014
Registry last updated
Jun 9, 2015

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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