Embryo Selection by Time Lapse Monitoring for Single Embryo Transfer ("SET")

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Kaali Institute IVF Center
Sponsor:
Information provided by (Responsible Party):
Kaali Institute IVF Center
ClinicalTrials.gov Identifier:
NCT01694641
First received: September 21, 2012
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

A multiple pregnancy is an undesired outcome of assisted reproduction. Current embryo selection technologies are inefficient in identifying the embryo with the highest implantation potential. Time lapse (TL) embryo monitoring provides additional information about embryo development and therefore may aid embryo selection. The investigators aim is to study whether TL monitoring is superior to traditional embryo observation when a single blastocyst is selected for transfer (ET).


Condition Intervention Phase
Clinical Pregnancy After Single Embryo Transfer
Other: observation of embryo development by time lapse embryo monitoring versus standard once a day embryo evaluation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Time Lapse Embryo Monitoring Versus Standard Embryo Monitoring for Selection for Single Blastocyst Transfer

Further study details as provided by Kaali Institute IVF Center:

Primary Outcome Measures:
  • clinical pregnancy [ Time Frame: clinical pregnancy will be assessed at week 8 of pregnancy ] [ Designated as safety issue: No ]
    intrauterine pregnancy with heartbeat


Secondary Outcome Measures:
  • implantation rate [ Time Frame: implantation rate will be assessed at week 6 of pregnancy ] [ Designated as safety issue: No ]
    intrauterine sac/ embryo transferred


Other Outcome Measures:
  • time lapse score [ Time Frame: the time lapse score is assessed on the day of embryo transfer (day 5 after the egg retrieval) ] [ Designated as safety issue: No ]
    a score based on 8 observations by time lapse monitoring


Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: time lapse embryo observation
Upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation
Other: observation of embryo development by time lapse embryo monitoring versus standard once a day embryo evaluation
standard embryo monitoring
upon fertilization embryos are observed once a day by the embryologist to check for development
Other: observation of embryo development by time lapse embryo monitoring versus standard once a day embryo evaluation

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age < 36 yrs
  • baseline FSH <10 IU/l
  • regular 25-35 day cycles
  • less than 2 previous failed IVF cycles
  • intact uterus
  • an indication for IVF
  • BMI <18- <30 kg/m2
  • acceptance of single embryo transfer

Exclusion Criteria:

  • PCOS
  • Sperm obtained by surgical extraction
  • chromosome abnormality
  • Presence of hydrosalpinx
  • stage III/IV endometriosis
  • Less than 3 good quality day 3 embryos
  • lack of consent
  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: NCT01694641

Contacts
Contact: Peter Kovacs, MD +36-1-202-2802 peterkovacs1970@hotmail.com
Contact: Szabolcs Matyas, PhD +36-1-202-2802 szmatyas@hotmail.com

Locations
Hungary
Kaali Institute IVF Center Recruiting
Budapest, Hungary, 1125
Principal Investigator: Peter Kovacs, MD         
Sponsors and Collaborators
Kaali Institute IVF Center