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Clinical Trials/NCT01939626
NCT01939626
Completed
Not Applicable

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

Vitrolife4 sites in 2 countries128 target enrollmentSeptember 2013
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Vitrolife
Enrollment
128
Locations
4
Primary Endpoint
Percentage of good quality blastocysts
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
February 2014
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Vitrolife
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • % GQE DAY 3(Measured 3 days after oocyte pick-up)
  • Blast. rate(Measured 5 and 6 days after oocyte pick-up.)
  • Blast. Utilization rate(Measured 5 and 6 days after oocyte pick-up)

Study Sites (4)

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