Comparative Effect of Theipoental and Propofol in IVF Outcome

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 2013

Interventions

  • 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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aristotle University Of Thessaloniki
  • Provider of Information About this Clinical Study
    • Principal Investigator: E.M. Kolibianakis, Professor – Aristotle University Of Thessaloniki

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