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

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ClinicalTrials.gov Identifier: NCT01939626
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Vitrolife

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.

Condition or disease Intervention/treatment Phase
Infertility Device: Single-step medium Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Comparison of Human Embryonic Development Using Sequential and Single Media in IVF Monitored by Time-lapse Imaging.
Actual Study Start Date : September 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Experimental: Single-step medium
embryos will be cultured in a single-step medium for 5 days with no change
Device: Single-step medium
This medium will allow in vitro culture of human embryos for 5/6 days




Primary Outcome Measures :
  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.


Other Outcome Measures:
  1. Biochemical pregnancy rate [ Time Frame: within one month following embryo transferllowing embryo transfer ]
    Percentage of embryo transfers that lead to a recorded pregnancy.

  2. Implantation rate [ Time Frame: Within 3 months following embryo transfer ]
    Percentage of embryos transferred that implant into the uterus by evidence of a fetal sac under ultrasound.

  3. On going pregnancy rate [ Time Frame: within 6 months following embryo transfer ]
    Percentage of embryo transfers that lead to a recorded sustained pregnancy beyond 12 weeks.

  4. Live birth rate [ Time Frame: within 12 months following embryo transfer ]
    Percentage of embryo transfers that lead to a live birth.

  5. Birth weight [ Time Frame: within 12 months following embryo transfer ]
    Birth weight will be measured in grams.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939626


Locations
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United States, California
Pacific Fertility Center
San Francisco, California, United States, 94133
United States, Texas
Frisco IVF
Frisco, Texas, United States, 75034
Sweden
Fertilitetscentrum
Goteburg, Sweden, 40229
Skanes University Hospital
Malmo, Sweden, 20502
Sponsors and Collaborators
Vitrolife
Investigators
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Principal Investigator: Thorir Hardarson, PhD Fertilitetscentrum AB

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vitrolife
ClinicalTrials.gov Identifier: NCT01939626     History of Changes
Other Study ID Numbers: TL-SCM-2013
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018

Keywords provided by Vitrolife:
embryo
culture

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female