InfertilityPhase 4NCT02494180
A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
A Phase 4 study testing fentanyl, pethidine and Diazepam in people with Infertility, run by Kwong Wah Hospital.
Trial summary
The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- fentanyl, pethidine and Diazepam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Feb 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- presence of both ovaries;
- body mass index less than 30
- written informed consent and
- Chinese
Who cannot join
- IVF cycle converted from ovulation induction or intrauterine insemination cycles;
- patient requests general anaesthesia for TUGOR;
- history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;
- less than 3 dominant follicles present;
- dominant follicles present in one ovary only and
- TUGOR performed on one side only.
About this study
Official title: A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR
Read the detailed description
In-vitro fertilization / embryo transfer (IVF / ET) is a well-established method to treat various causes of infertility. It involves multiple follicular development, retrieval of oocytes and embryo transfer after fertilization. Egg retrieval at the majority of IVF units is performed through the transvaginal route under ultrasound guidance (TUGOR) [1]. During TUGOR, the needle has to pass through the mucosa in the vaginal vault in order to puncture the follicles in the ovary. The procedures are generally short, lasting about 20-30 minutes but are still painful without anaesthesia or analgesia.
Intravenous sedation with or without local anaesthesia is the most widely used method. Conscious sedation is a safe and cost-effective method of providing analgesia and anesthesia for TUGOR. [2] It is easy to administer in cooperative and motivated patients. It has a relatively low risk for adverse effects on oocyte and embryo quality and pregnancy rates. [3] Paracervical block (PCB) in conjunction with conscious sedation during TUGOR was shown to significantly reduce the pain during TUGOR when compared to PCB alone [4].
A Cochrane review on various methods of sedation and analgesia for pain relief during TUGOR has shown no single method or delivery system appeared superior for pregnancy rates and pain relief. [5] Most of the methods seemed to work well and the effect was usually enhanced by addition of another method such as pain relief with paracervical block. [6]
The investigators' reproductive centre has recently aligned with the Assisted Reproduction Centre of the University of Hong Kong (HKU). The investigators are using 0.1mg fentanyl and 5mg midazolam intravenously for pain relief in TUGOR at Kwong Wah Hospital (KWH) whereas 5mg diazepam and 25mg pethidine intravenously are being used in HKU. The investigators would like to compare fentanyl and midazolam vs diazepam and pethidine in terms of pain levels and post-operative side effects of TUGOR in this prospective non-inferiority randomized double-blinded trial. The investigators postulate there are no differences in the pain levels between two groups but the postoperative side effects may be different.
- Conditions
- Infertility
- Keywords
- fentanyl, midazolam, pethidine, diazepam
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
arm A receiving iv fentanyl
pethidineDrug
arm B receiving iv pethidine
DiazepamDrug
Also called valium
arm B receiving iv diazepam
MidazolamDrug
Also called dormicum
arm A receiving iv midazolam
| Study group | Role | What they receive |
|---|---|---|
| A: intravenous fentanyl, midazolam | Placebo comparator | group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval Receives: Drug: fentanyl; Drug: Midazolam |
| B: intravenous pethidine, diazepam | Placebo comparator | group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval Receives: Drug: pethidine; Drug: Diazepam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level During Oocyte Retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Measured: will be assessed within 4 hours of oocyte retrieval
Pain Level After Oocyte Retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Measured: will be assessed within 4 hours of oocyte retrieval
Secondary outcomes (6)
Percentage of Participants With Side Effects by Type
side effects will be scored by yes or no
Measured: will be assessed within 4 hours of oocyte retrieval
Patient's Satisfaction on Oocyte Retrieval
satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory)
Measured: will be assessed within 4 hours of oocyte retrieval
Clinical Pregnancy Rate
presence of intrauterine sac in ultrasound after a positive pregnancy test
Measured: will be assessed within ten weeks of oocyte retrieval
Ongoing Pregnancy Rate
positive fetal heart pulsation seen in ultrasound at eight weeks of gestation
Measured: will be assessed within ten weeks of oocyte retrieval
Patient's Satisfaction on Pain Relief
satisfaction on pain relief will be scored at 0-10 (10 being most satisfied)
Measured: within 4 hours after retrieval
Sedation Level
S = sleeping, easily aroused; 1 = awake and alert; 2 = occasionally drowsy, easy to arouse; 3 = frequently drowsy, arousable, drifts off to sleep during conversation; 4 = somnolent, minimal or no response to stimuli
Measured: immediately after retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startMar 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Queen Mary Hospital, Hong Kong
- Responsible party
- Principal investigator, lydia lai, Kwong Wah Hospital
- Investigators
- Shui Fan Lai, Principal investigator, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494180
- Sponsor's protocol ID
- KW/FR-15-021(83-22)
- Status last verified
- Feb 2019
- First submitted
- 17 Jun 2015
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-inferiority Randomized Double-blinded Trial Comparing Fentanyl and Midazolam vs Diazepam and Pethidine for Pain Relief During Oocyte Retrieval
- ClinicalTrials.gov ID
- NCT02494180
- Acronym / sponsor ID
- KW/FR-15-021(83-22)
- Conditions
- Infertility
- Keywords
- fentanyl, midazolam, pethidine, diazepam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Queen Mary Hospital, Hong Kong
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the trial is to compare fentanyl and midazolam vs diazepam and pethidine in terms of the pain levels and post-operative side effects of TUGOR
Detailed description
In-vitro fertilization / embryo transfer (IVF / ET) is a well-established method to treat various causes of infertility. It involves multiple follicular development, retrieval of oocytes and embryo transfer after fertilization. Egg retrieval at the majority of IVF units is performed through the transvaginal route under ultrasound guidance (TUGOR) [1]. During TUGOR, the needle has to pass through the mucosa in the vaginal vault in order to puncture the follicles in the ovary. The procedures are generally short, lasting about 20-30 minutes but are still painful without anaesthesia or analgesia.
Intravenous sedation with or without local anaesthesia is the most widely used method. Conscious sedation is a safe and cost-effective method of providing analgesia and anesthesia for TUGOR. [2] It is easy to administer in cooperative and motivated patients. It has a relatively low risk for adverse effects on oocyte and embryo quality and pregnancy rates. [3] Paracervical block (PCB) in conjunction with conscious sedation during TUGOR was shown to significantly reduce the pain during TUGOR when compared to PCB alone [4].
A Cochrane review on various methods of sedation and analgesia for pain relief during TUGOR has shown no single method or delivery system appeared superior for pregnancy rates and pain relief. [5] Most of the methods seemed to work well and the effect was usually enhanced by addition of another method such as pain relief with paracervical block. [6]
The investigators' reproductive centre has recently aligned with the Assisted Reproduction Centre of the University of Hong Kong (HKU). The investigators are using 0.1mg fentanyl and 5mg midazolam intravenously for pain relief in TUGOR at Kwong Wah Hospital (KWH) whereas 5mg diazepam and 25mg pethidine intravenously are being used in HKU. The investigators would like to compare fentanyl and midazolam vs diazepam and pethidine in terms of pain levels and post-operative side effects of TUGOR in this prospective non-inferiority randomized double-blinded trial. The investigators postulate there are no differences in the pain levels between two groups but the postoperative side effects may be different.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: intravenous fentanyl, midazolam | Placebo comparator | Drug: fentanyl, Drug: Midazolamgroup A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval |
| B: intravenous pethidine, diazepam | Placebo comparator | Drug: pethidine, Drug: Diazepamgroup B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- presence of both ovaries;
- body mass index less than 30
- written informed consent and
- Chinese
Key exclusion criteria (6 listed)
- IVF cycle converted from ovulation induction or intrauterine insemination cycles;
- patient requests general anaesthesia for TUGOR;
- history of drug sensitivity to lignocaine/fentanyl/midazolam/diazepam/pethidine;
- less than 3 dominant follicles present;
- dominant follicles present in one ovary only and
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 |
|---|---|---|
| fentanylarm A receiving iv fentanyl | Drug | A: intravenous fentanyl, midazolam |
| pethidinearm B receiving iv pethidine | Drug | B: intravenous pethidine, diazepam |
| DiazepamAlso: valiumarm B receiving iv diazepam | Drug | B: intravenous pethidine, diazepam |
| MidazolamAlso: dormicumarm A receiving iv midazolam | Drug | A: intravenous fentanyl, midazolam |
Primary outcome
Pain Level During Oocyte Retrieval
Time frame: will be assessed within 4 hours of oocyte retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
Pain Level After Oocyte Retrieval
Time frame: will be assessed within 4 hours of oocyte retrieval
The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful
6 secondary outcomes
Percentage of Participants With Side Effects by Type
Time frame: will be assessed within 4 hours of oocyte retrieval
Patient's Satisfaction on Oocyte Retrieval
Time frame: will be assessed within 4 hours of oocyte retrieval
Clinical Pregnancy Rate
Time frame: will be assessed within ten weeks of oocyte retrieval
Ongoing Pregnancy Rate
Time frame: will be assessed within ten weeks of oocyte retrieval
Patient's Satisfaction on Pain Relief
Time frame: within 4 hours after retrieval
Sedation Level
Time frame: immediately after retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Shui Fan Lai principal investigator
Kwong Wah Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fentanyl, pethidine and Diazepam in people with Infertility, run by Kwong Wah Hospital.
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 4 inclusion and 6 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Level During Oocyte Retrieval (time frame: will be assessed within 4 hours of oocyte retrieval). The study lists 2 primary outcomes in all. 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 5 Mar 2019.