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

This study has been terminated.
(No statistical difference observed for outcomes.)
Sponsor:
Information provided by (Responsible Party):
Dr. Murat Çetinkaya, Memorial Sisli Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT01773603
First received: January 18, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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 Intervention
Infertility
Device: Embryoscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Blastocyst Culture Using Time-lapse in Good Prognosis IVF Patients and Elective Single Embryo Transfer

Resource links provided by NLM:


Further study details as provided by Memorial Sisli Hospital, Istanbul:

Primary Outcome Measures:
  • Blastocyst formation rate [ Time Frame: 5th day of embryonic development ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 7th week of pregnancy ] [ Designated as safety issue: No ]
    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.


Enrollment: 64
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Time-lapse monitoring of human embryos in Embryoscope

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01773603

Locations
Turkey
Sisli Memorial Hospital
Istanbul, Turkey, 34385
Sponsors and Collaborators
Dr. Murat Çetinkaya
Investigators
Study Director: Semra Kahraman, MD, Prof Sisli Memorial Hospital
  More Information

No publications provided

Responsible Party: Dr. Murat Çetinkaya, R&D Laboratory Manager, Memorial Sisli Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT01773603     History of Changes
Other Study ID Numbers: MC0405, IMH2013-1
Study First Received: January 18, 2013
Last Updated: January 18, 2013
Health Authority: Turkey: Ethics Committee
Turkey: Ministry of Health

Keywords provided by Memorial Sisli Hospital, Istanbul:
Time-lapse
morphokinetics
blastocyst transfer
eSET

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

ClinicalTrials.gov processed this record on September 30, 2014