InfertilityNCT00554424
Local Anaesthetic for Transvaginal Egg Collection in IVF
A study testing lignocaine and normal saline in people with Infertility, run by The Fertility Centre, New Zealand at 1 site in New Zealand.
Trial summary
The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- lignocaine and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteNew Zealand
- Study dates
- Mar 2002to Jul 2002
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- About to undergo transvaginal oocyte retrieval
Who cannot join
- Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)
- Allergy to lignocaine
- Oocytes only to be collected from one ovary
- Procedure expected to be exceptionally painful
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.
Read the detailed description
Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.
- Conditions
- Infertility
- Being tested
- lignocaine, normal saline
- Keywords
- oocyte retrieval, pain relief, Local anaesthetic
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaineDrug
20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary
normal salineDrug
20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary
| Study group | Role | What they receive |
|---|---|---|
| LA | Active comparator | Intravaginal and pre-peritoneal injection of 1% lignocaine into each side of the upper vagina under ultrasound guidance immediately prior to ultrasound guided transvaginal oocyte retrieval Receives: Drug: lignocaine |
| P | Placebo comparator | Intravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose of iv fentanyl used during oocyte collection
Measured: Length of oocyte collection (minutes)
Secondary outcomes (11)
Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection
Measured: Actual point in time
Length of oocyte collection procedure
Measured: Time taken (minutes)
Occurence of nausea or vomiting
Measured: During oocyte collection procedure
Administration of atropine or anti -emetic
Measured: During oocyte collection procedure
Time spent in recovery room
Measured: Time from end of oocyte collection until discharge home
No of oocytes collected
Measured: During oocyte collection procedure
Number of oocytes fertilised
Measured: Assessed 18 hours after oocyte collection
Pregnancy outcome
Measured: 7 weeks gestation
Number of embryos frozen
Measured: Within 6 days of oocyte collection
Pulse rate at beginning and end of egg collection
Measured: Point in time
Maximum pulse rate during oocyte collection
Measured: Point in time during oocyte collection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startMar 2002
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Fertility Centre, New Zealand
- Sponsor type
- University, hospital or other
- Investigators
- Sarah A Wakeman, FRANZCOG, Principal investigator, The Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554424
- Sponsor's protocol ID
- 01/12/180
- Status last verified
- Nov 2007
- First submitted
- 3 Nov 2007
- Last updated
- 6 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Intravaginal Lignocaine Injection Versus Placebo for Analgesia During Oocyte Recovery in an IVF Cycle
- ClinicalTrials.gov ID
- NCT00554424
- Acronym / sponsor ID
- 01/12/180
- Conditions
- Infertility
- Keywords
- oocyte retrieval, pain relief, Local anaesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The Fertility Centre, New ZealandUniversity, hospital or other
- Study start
- Mar 2002
- Study completion
- Jul 2002 (actual)
- First posted
- 6 Nov 2007 (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.
The purpose of this study is to see whether injecting local anaesthetic into the vaginal tissues,just prior to transvaginal egg collection,will decrease the amount of pain experienced by women having their eggs collected on an IVF cycle. All women will also receive intravenous sedation as required as well as a sleeping tablet thirty minutes prior to the procedure which is our routine procedure for egg collection.
Detailed description
Transvaginal oocyte retrieval is the most common method of oocyte collection in IVF cycles. A variety of different methods are used to provide analgesia/anesthesia for oocyte collection. Our unit has always used an oral pre-medication followed by intravenous fentanyl during the procedure but this doesn't seem to provide adequate analgesia for some women. The aim of this study was to compare the addition of intravaginal local anaesthetic injection versus saline placebo to our usual analgesia regime to see whether less intravenous fentanyl was required and whether the women experienced less pain during oocyte collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LA | Active comparator | Drug: lignocaineIntravaginal and pre-peritoneal injection of 1% lignocaine into each side of the upper vagina under ultrasound guidance immediately prior to ultrasound guided transvaginal oocyte retrieval |
| P | Placebo comparator | Drug: normal salineIntravaginal saline placebo injection into each side of upper vagina under ultrasound guidance immediately prior to transvaginal oocyte retrieval |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- About to undergo transvaginal oocyte retrieval
Key exclusion criteria (4 listed)
- Already undergone oocyte retrieval and participated in study (i.e. 2nd or more oocyte collection procedure during study period)
- Allergy to lignocaine
- Oocytes only to be collected from one ovary
- Procedure expected to be exceptionally painful
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 |
|---|---|---|
| lignocaine20 mls of 1% lignocaine solution for injection, 10mls into each side of upper vagina, under ultrasound guidance immediately prior to transvaginal oocyte retrieval under ultrasound guidance from each ovary | Drug | LA |
| normal saline20mls of normal saline solution, 10mls injected each side into upper vagina under ultrasound guidance, immediately prior to ultrasound guided transvaginal oocyte retrieval from each ovary | Drug | P |
Primary outcome
Total dose of iv fentanyl used during oocyte collection
Time frame: Length of oocyte collection (minutes)
11 secondary outcomes
Pain score (cm on a Visual Analogue Scale) at 6 different points during oocyte collection
Time frame: Actual point in time
Length of oocyte collection procedure
Time frame: Time taken (minutes)
Occurence of nausea or vomiting
Time frame: During oocyte collection procedure
Administration of atropine or anti -emetic
Time frame: During oocyte collection procedure
Time spent in recovery room
Time frame: Time from end of oocyte collection until discharge home
No of oocytes collected
Time frame: During oocyte collection procedure
Number of oocytes fertilised
Time frame: Assessed 18 hours after oocyte collection
Pregnancy outcome
Time frame: 7 weeks gestation
Number of embryos frozen
Time frame: Within 6 days of oocyte collection
Pulse rate at beginning and end of egg collection
Time frame: Point in time
Maximum pulse rate during oocyte collection
Time frame: Point in time during oocyte collection procedure
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 6 Nov 2007.
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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.
Sarah A Wakeman, FRANZCOG principal investigator
The Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lignocaine and normal saline in people with Infertility, run by The Fertility Centre, New Zealand at 1 site in New Zealand.
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 1 inclusion and 4 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 6 Nov 2007. 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 New Zealand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Total dose of iv fentanyl used during oocyte collection (time frame: Length of oocyte collection (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2007.