Back to resultsComparative Effect of Theipoental and Propofol in IVF Outcome
Primary Purpose
Subfertility
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Propofol
Thiopental
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility
Eligibility Criteria
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
Sites / Locations
- Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Propofol
Thiopental
Arm Description
In this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval
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
Outcomes
Primary Outcome Measures
Fertilization rate
The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient
Secondary Outcome Measures
Number of MII oocytes
Pregnancy rate
Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer
Implantation rate
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
Full Information
NCT ID
NCT02377778
First Posted
February 25, 2015
Last Updated
March 3, 2015
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT02377778
Brief Title
Comparative Effect of Theipoental and Propofol in IVF Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Experimental
Arm Description
In this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval
Arm Title
Thiopental
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval
Intervention Type
Drug
Intervention Name(s)
Thiopental
Intervention Description
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
Primary Outcome Measure Information:
Title
Fertilization rate
Description
The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient
Time Frame
First 24h after oocyte retrieval
Secondary Outcome Measure Information:
Title
Number of MII oocytes
Time Frame
12h after oocyte rertieval
Title
Pregnancy rate
Description
Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer
Time Frame
14 days after embryo transfer
Title
Implantation rate
Description
Number of gestational sacs per embryos transferred per patient
Time Frame
40 days after embryo traansfer
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54603
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
26515147
Citation
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.
Results Reference
derived
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Comparative Effect of Theipoental and Propofol in IVF Outcome
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