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Completed

NCT Number: NCT01939626

Comparison of Human Embryo Development Using Sequential and Single Media With Time-lapse Imaging

The purpose of this study is to compare human embryo in vitro development in sequential and single-step culture medium using time-lapse imaging.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertilitetscentrum, Gothenburg, Sweden

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About this study

Objective: To study whether a culture medium that allows undisturbed culture supports human embryo development to the blastocyst stage equivalently to a well-established sequential media.

Design: Randomized, double-blinded sibling trial. Setting: Independent in vitro fertilization (IVF) clinics. Patient(s): One hundred twenty-eight patients, with 1,356 zygotes randomized into two study arms.

Intervention(s): Embryos from each patient were randomly allocated into two study arms to compare embryo development on a time-lapse system using a single-step medium or sequential media.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 6 or more normal embryos following egg retrieval and fertilization.
  • Female patients aged 21-40 years or 21-55 years who are using an egg donor.
  • Patients using fresh or frozen ejaculated sperm

Exclusion criteria

  • Previous history of cancer
  • Day 3 embryo transfer

Treatment and study plan

Single-step medium

Device

This medium will allow in vitro culture of human embryos for 5/6 days

Other names: Single step culture medium

Standard culture medium

Device

This culture system needs media change on day 3 of culture.

Primary outcomes

  1. Percentage of good quality blastocysts

    Time frame: 5 days of in vitro embryo culture

    A cohort of human embryos will be divided into two different media. The ability of the media to support human embryo development will be determined using the standard assessment of the percentage of embryos that achieve a defined embryo grade.

Secondary outcomes

  1. % GQE DAY 3

    Time frame: Measured 3 days after oocyte pick-up

    Percentage of good quality embryos on day 3 of development

  2. Blast. Utilization rate

    Time frame: Measured 5 and 6 days after oocyte pick-up

    Number of blastocyst that are cryopreserved or transfered on either day 5 or 6 of embryo development.

  3. Blast. rate

    Time frame: Measured 5 and 6 days after oocyte pick-up.

    Number of embryos reaching the blastocyts stage on either day 5 or day 6.

Sponsors and collaborators

Lead sponsor

Vitrolife

Industry

Registry information

Official study title

Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2013
Registry last updated
Jan 12, 2021

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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