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OpenTrials
Completed

NCT Number: NCT02377778

Comparative Effect of Theipoental and Propofol in IVF Outcome

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

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

Thessaloniki, 54603, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

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

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 4, 2015
Registry last updated
Mar 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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