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Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Sponsor
Dr. Murat Çetinkaya (Other)
Overall Status
Terminated
CT.gov ID
NCT01773603
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
7
Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Choosing the best embryo for transfer has become the major challenge in in vitro fertilization (IVF). Morphology alone is obviously not enough and time-lapse incubation has added embryo development kinetics as another selection criterion.

This study was designed to select for the top blastocyst to be replaced, while increasing the pregnancy chance, with the local legislation regulating the number of embryos to be transferred and to establish a morphokinetic standard to be used in our clinical setting.

Condition or Disease Intervention/Treatment Phase
  • Device: Embryoscope
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jul 1, 2012

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Conventional incubation

Five-day embryo culture in conventional incubators
Active Comparator: Embryoscope

Five-day embryo culture in embryoscope which is an incubator with a built-in camera

Device: Embryoscope
Five-day embryo culture in embryoscope which is an incubator with a built-in camera
Other Names:
  • Time-lapse monitoring of human embryos in Embryoscope

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blastocyst formation rate [5th day of embryonic development]

    Secondary Outcome Measures

    1. Clinical pregnancy rate [7th week of pregnancy]

      Clinical pregnancy was defined as the presence of a gestational sac detected on ultrasound 3 weeks after the first βhCG test, which was performed 14 days after oocyte retrieval.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients in their first or second ART treatment cycle

    • no recurrent spontaneous abortions

    • age<35 years

    • BMI<28 kg/m2

    • ≥8 oocytes retrieved

    Exclusion Criteria:

    • severe endometriosis

    • polycystic ovary syndrome

    • hydrosalpynx

    • uterine pathology

    • severe male factor (presenting less than 5 million motile sperm cells in total in the ejaculate)

    • very severe morphological sperm defects (mainly globozoospermic or macrocephalic samples)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sisli Memorial Hospital Istanbul Turkey 34385

    Sponsors and Collaborators

    • Dr. Murat Çetinkaya

    Investigators

    • Study Director: Semra Kahraman, MD, Prof, Sisli Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Murat Çetinkaya, R&D Laboratory Manager, Memorial Sisli Hospital, Istanbul
    ClinicalTrials.gov Identifier:
    NCT01773603
    Other Study ID Numbers:
    • MC0405
    • IMH2013-1
    First Posted:
    Jan 23, 2013
    Last Update Posted:
    Jan 23, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Dr. Murat Çetinkaya, R&D Laboratory Manager, Memorial Sisli Hospital, Istanbul
    Time-lapse
    morphokinetics
    blastocyst transfer
    eSET
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Jan 23, 2013