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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

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.

Condition or disease Intervention/treatment Phase
Subfertility Drug: Propofol Drug: Thiopental Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : January 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arm Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of MII oocytes [ Time Frame: 12h after oocyte rertieval ]
  2. Pregnancy rate [ Time Frame: 14 days after embryo transfer ]
    Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer

  3. Implantation rate [ Time Frame: 40 days after embryo traansfer ]
    Number of gestational sacs per embryos transferred per patient

  4. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377778


Locations
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Greece
Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
Thessaloniki, Greece, 54603
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: E.M. Kolibianakis, Professor, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT02377778    
Other Study ID Numbers: UHR-8
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: March 4, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Thiopental
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action