SubfertilityPhase 4NCT02377778
Comparative Effect of Theipoental and Propofol in IVF Outcome
A Phase 4 study testing Propofol and Thiopental in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Propofol and Thiopental
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing oocyte retrieval for IVF under general anesthesia
- age ≤45 years
Who cannot join
- women with a known hypersensitivity to the active substance of the investigating drugs or any of their excipients
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit for Human Reproduction, 1st Dept of OB/Gyn, Medical School, Aristotle UNiversity of Thessaloniki
Thessaloniki, Thessaloniki, 54603
About this study
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.
- Conditions
- Subfertility
- Being tested
- Propofol, Thiopental
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval
ThiopentalDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | In this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval Receives: Drug: Propofol |
| Thiopental | Active comparator | 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 Receives: Drug: Thiopental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization rate
The number of oocytes fertilized divided by the number of oocytes in which fertilization was attempted per randomized patient
Measured: First 24h after oocyte retrieval
Secondary outcomes (4)
Number of MII oocytes
Measured: 12h after oocyte rertieval
Pregnancy rate
Patients with positive (>20 IU/L) b-hCG test at 14 days after embryo transfer
Measured: 14 days after embryo transfer
Implantation rate
Number of gestational sacs per embryos transferred per patient
Measured: 40 days after embryo traansfer
The concentration of propofol or thiopental in the follicular fluid of the dominant (larger) follicle aspirated at oocyte retrieval
Measured: 12 hours after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startJan 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377778
- Sponsor's protocol ID
- UHR-8
- Status last verified
- Feb 2015
- First submitted
- 25 Feb 2015
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26515147
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Theipoental and Propofol in IVF Outcome
- ClinicalTrials.gov ID
- NCT02377778
- Acronym / sponsor ID
- UHR-8
- Conditions
- Subfertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: PropofolIn this arm patients will be receiving propofol for anaesthesia at doses 3-5mg depending on the time needed to complete oocyte retrieval |
| Thiopental | Active comparator | Drug: ThiopentalIn 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women undergoing oocyte retrieval for IVF under general anesthesia
- age ≤45 years
Key exclusion criteria (1 listed)
- women with a known hypersensitivity to the active substance of the investigating drugs or any of their excipients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval | Drug | Propofol |
| ThiopentalPatients 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 | Drug | Thiopental |
Primary outcome
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
4 secondary outcomes
Number of MII oocytes
Time frame: 12h after oocyte rertieval
Pregnancy rate
Time frame: 14 days after embryo transfer
Implantation rate
Time frame: 40 days after embryo traansfer
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Derived from this study: PubMed 26515147Goutziomitrou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Thiopental in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization rate (time frame: First 24h after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02377778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.