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Comparative Effect of Theipoental and Propofol in IVF Outcome

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ClinicalTrials.gov Identifier: NCT02377778
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : March 4, 2015
Sponsor:
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki

Tracking Information
First Submitted Date  ICMJE February 25, 2015
First Posted Date  ICMJE March 4, 2015
Last Update Posted Date March 4, 2015
Study Start Date  ICMJE January 2009
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Fertilization rate [ Time Frame: First 24h after oocyte retrieval ]
The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Number of MII oocytes [ Time Frame: 12h after oocyte rertieval ]
  • Pregnancy rate [ Time Frame: 14 days after embryo transfer ]
    Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer
  • Implantation rate [ Time Frame: 40 days after embryo traansfer ]
    Number of gestational sacs per embryos transferred per patient
  • The concentration of propofol or thiopental in the follicular fluid of the dominant (larger) follicle aspirated at oocyte retrieval [ Time Frame: 12 hours after oocyte retrieval ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effect of Theipoental and Propofol in IVF Outcome
Official Title  ICMJE Not Provided
Brief Summary In this study the aim is to compare the effect of the type of anaesthetic drug used during oocyte retrieval on fertilization rates of oocytes retrieved after ovarian stimulation for in-vitro fertilization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Subfertility
Intervention  ICMJE
  • Drug: Propofol
    Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval
  • Drug: Thiopental
    Patients will receive thiopental in addition to fentanyl for introduction and maintanance of anaesthesia at doses 7mg. IF required patients will receive a repeat dose of 1-3mg of thiopental depending on the totla time needed to complete oocyte retrieval
Study Arms  ICMJE
  • Experimental: Propofol
    In this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval
    Intervention: Drug: Propofol
  • Active Comparator: Thiopental
    In this arm patients will receive thiopental for anaesthesia at doses 7mg and a repeat dose of 2-3mg depending on the time needed to completed oocyte retrieval
    Intervention: Drug: Thiopental
Publications * Goutziomitrou E, Venetis CA, Kolibianakis EM, Bosdou JK, Parlapani A, Grimbizis G, Tarlatzis BC. Propofol versus thiopental sodium as anaesthetic agents for oocyte retrieval: a randomized controlled trial. Reprod Biomed Online. 2015 Dec;31(6):752-9. doi: 10.1016/j.rbmo.2015.08.013. Epub 2015 Sep 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2015)
180
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • women undergoing oocyte retrieval for IVF under general anesthesia
  • age ≤45 years

Exclusion Criteria:

  • women with a known hypersensitivity to the active substance of the investigating drugs or any of their excipients
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377778
Other Study ID Numbers  ICMJE UHR-8
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party E.M. Kolibianakis, Aristotle University Of Thessaloniki
Study Sponsor  ICMJE Aristotle University Of Thessaloniki
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aristotle University Of Thessaloniki
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP