Comparative Effect of Theipoental and Propofol in IVF Outcome

Phase 4

Completed

• Conditions: Subfertility
• Interventions: Drug: Thiopental; Drug: Propofol

• Registration Number: NCT02377778
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-02
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-03
• Last Update Submitted: 2015-03-03
• Study First Posted: 2015-03-04
• Last Update Posted: 2015-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thiopental	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
Propofol	Propofol	In this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval

Primary Outcome Measures

Name	Time	Method
Fertilization rate	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

Name	Time	Method
Number of MII oocytes	12h after oocyte rertieval
Implantation rate	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	12 hours after oocyte retrieval
Pregnancy rate	14 days after embryo transfer	Patients with positive (\>20 IU/L) b-hCG test at 14 days after embryo transfer

Trial Locations

Locations (1)

Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki; 🇬🇷 Thessaloniki, Greece