Comparative Effect of Theipoental and Propofol in IVF Outcome

Subfertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377778
• Other study ID #: UHR-8
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2015
• Last updated: March 3, 2015
• Start date: January 2009
• Est. completion date: March 2013

Study information

• Verified date: February 2015
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Social Insurance
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subfertility

Intervention

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
• 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

Locations

Country	Name	City	State
Greece	Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient	First 24h after oocyte retrieval	No
Secondary	Number of MII oocytes		12h after oocyte rertieval	No
Secondary	Pregnancy rate	Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer	14 days after embryo transfer	No
Secondary	Implantation rate	Number of gestational sacs per embryos transferred per patient	40 days after embryo traansfer	No
Secondary	The concentration of propofol or thiopental in the follicular fluid of the dominant (larger) follicle aspirated at oocyte retrieval		12 hours after oocyte retrieval	No