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| Name | Class |
|---|---|
| The University of Hong Kong | OTHER |
| Queen Mary Hospital, Hong Kong | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: intravenous fentanyl, midazolam | Placebo Comparator | group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval |
|
| B: intravenous pethidine, diazepam | Placebo Comparator | group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fentanyl | Drug | arm A receiving iv fentanyl |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Level During Oocyte Retrieval | The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful | 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 | will be assessed within 4 hours of oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Side Effects by Type | side effects will be scored by yes or no | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shui Fan Lai | Kwong Wah Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Intravenous Fentanyl, Midazolam | group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval fentanyl: arm A receiving iv fentanyl Midazolam: arm A receiving iv midazolam |
| FG001 | B: Intravenous Pethidine, Diazepam | group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval pethidine: arm B receiving iv pethidine Diazepam: arm B receiving iv diazepam |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Intravenous Fentanyl, Midazolam | group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval fentanyl: arm A receiving iv fentanyl Midazolam: arm A receiving iv midazolam |
| BG001 | B: Intravenous Pethidine, Diazepam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Level During Oocyte Retrieval | The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful | Posted | Median | Inter-Quartile Range | score on a scale | will be assessed within 4 hours of oocyte retrieval |
|
within 18 days of hCG which is also the urine pregnancy test date
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Intravenous Fentanyl, Midazolam | group A will be given intravenous 0.1mg fentanyl and 5mg midazolam prior oocyte retrieval fentanyl: arm A receiving iv fentanyl Midazolam: arm A receiving iv midazolam |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr SF Lai | Kwong Wah Hospital | 85223322311 | lsf087@ha.org.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2015 | Jan 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D008614 | Meperidine |
| D003975 | Diazepam |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007540 | Isonipecotic Acids |
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| pethidine |
| Drug |
arm B receiving iv pethidine |
|
| Diazepam | Drug | arm B receiving iv diazepam |
|
|
| Midazolam | Drug | arm A receiving iv midazolam |
|
|
| will be assessed within 4 hours of oocyte retrieval |
| Clinical Pregnancy Rate | presence of intrauterine sac in ultrasound after a positive pregnancy test | will be assessed within ten weeks of oocyte retrieval |
| Ongoing Pregnancy Rate | positive fetal heart pulsation seen in ultrasound at eight weeks of gestation | 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) | 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 | immediately after retrieval |
group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval pethidine: arm B receiving iv pethidine Diazepam: arm B receiving iv diazepam |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Pain Level After Oocyte Retrieval | The pain level will be scored using visual analogue scale 0-10, 0 = no pain, 10 =most painful | Posted | Median | Inter-Quartile Range | score on a scale | will be assessed within 4 hours of oocyte retrieval |
|
|
|
| Secondary | Percentage of Participants With Side Effects by Type | side effects will be scored by yes or no | Posted | Number | percentage of participants | will be assessed within 4 hours of oocyte retrieval |
|
|
|
| Secondary | Patient's Satisfaction on Oocyte Retrieval | satisfaction will be scored from 0-3 (0=excellent, 1=satisfactory, 2=fair, 3=unsatisfactory) | Posted | Number | percentage of participants | will be assessed within 4 hours of oocyte retrieval |
|
|
|
| Secondary | Clinical Pregnancy Rate | presence of intrauterine sac in ultrasound after a positive pregnancy test | Posted | Number | percentage of participants | will be assessed within ten weeks of oocyte retrieval |
|
|
|
| Secondary | Ongoing Pregnancy Rate | positive fetal heart pulsation seen in ultrasound at eight weeks of gestation | Posted | Number | percentage of participants | will be assessed within ten weeks of oocyte retrieval |
|
|
|
| Secondary | Patient's Satisfaction on Pain Relief | satisfaction on pain relief will be scored at 0-10 (10 being most satisfied) | Posted | Median | Inter-Quartile Range | score on a scale | within 4 hours after retrieval |
|
|
|
| Secondary | 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 | Posted | Count of Participants | Participants | immediately after retrieval |
|
|
|
| 0 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | B: Intravenous Pethidine, Diazepam | group B will be given intravenous 25mg pethidine, 5mg diazepam prior oocyte retrieval pethidine: arm B receiving iv pethidine Diazepam: arm B receiving iv diazepam | 0 | 85 | 0 | 85 | 0 | 85 |
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| D000147 |
| Acids, Heterocyclic |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| dizziness |
|
| drowsiness |
|
| shortness of breath |
|
| fair |
|
| unsatisfactory |
|
| 3 |
|
| 4 |
|
| S |
|
| missing data |
|