Phase 4
Completed N=170
A Non-inferiority Trial on Pain Relief During Oocyte Retrieval
Source: ClinicalTrials.gov NCT02494180 ↗Enrolled (actual)
170
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Pain Level During Oocyte Retrieval — 0; 4; 2.5; 5 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Level During Oocyte Retrieval |
0; 4; 2.5; 5 | — |
| PRIMARY Pain Level After Oocyte Retrieval |
0; 0; 2.3; 2 | — |
| SECONDARY Percentage of Participants With Side Effects by Type |
2.4; 7.1; 0; 1.2; 16.5; 4.7 | — |
| SECONDARY Patient's Satisfaction on Oocyte Retrieval |
47.7; 15.3; 38.8; 55.3; 11.8; 22.4 | — |
| SECONDARY Clinical Pregnancy Rate |
14.1; 23.5 | — |
| SECONDARY Ongoing Pregnancy Rate |
12.9; 21.2 | — |
| SECONDARY Patient's Satisfaction on Pain Relief |
8; 7 | — |
| SECONDARY Sedation Level |
15; 52; 14; 17; 16; 4 | — |
Eligibility Criteria
Inclusion Criteria
- presence of both ovaries;
- body mass index less than 30
- written informed consent and
- Chinese
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02494180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.