BridgeMD
Evaluation of a New Pain Management Regime for Oocyte Pick-Up During Fertility Treatment
EU CTIS ID: 2025-523018-10-00
What this study is testing
To demonstrate that a single pre-procedure dose of sublingual sufentanil 30 µg (Dzuveo) reduces intra-procedural pain during oocyte pick-up compared with the standard midazolam-based regimen, measured by repeated VAS (0–100 mm) scores recorded every two minutes throughout the procedure.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female adult undergoing IVF/ART with a planned transvaginal oocyte pick-up at UZ Brussel.
- Able to provide informed consent and comply with study procedures (pain ratings during OPU; 24-h follow-up).
- ASA physical status I–III under institutional OPU sedation/analgesia pathways.
- Meets institutional safety thresholds for ambulatory OPU (e.g., airway assessment, BMI and comorbidity limits) per site SOPs.
You likely can't join if
- Known allergy or hypersensitivity to Sufentanil, Midazolam, Paracetamol, Diclofenac, Alprazolam, Piritramide, or any excipients of these products.
- Inability to understand the study procedures or the local languages (Dutch/French/English) sufficiently to complete the questionnaires.
- Current use of MAOIs or within 14 days pre-OPU.
- History of substance abuse (opioids/benzodiazepines) within the past year.
- Pre-existing chronic pain conditions requiring chronic opioid therapy (Endometriosis is allowed unless the patient is on chronic daily opioids).
- History of substance abuse (alcohol or drugs).
See the full eligibility criteria
- Female adult undergoing IVF/ART with a planned transvaginal oocyte pick-up at UZ Brussel.
- Able to provide informed consent and comply with study procedures (pain ratings during OPU; 24-h follow-up).
- ASA physical status I–III under institutional OPU sedation/analgesia pathways.
- Meets institutional safety thresholds for ambulatory OPU (e.g., airway assessment, BMI and comorbidity limits) per site SOPs.
- Known allergy or hypersensitivity to Sufentanil, Midazolam, Paracetamol, Diclofenac, Alprazolam, Piritramide, or any excipients of these products.
- Inability to understand the study procedures or the local languages (Dutch/French/English) sufficiently to complete the questionnaires.
- Current use of MAOIs or within 14 days pre-OPU.
- History of substance abuse (opioids/benzodiazepines) within the past year.
- Pre-existing chronic pain conditions requiring chronic opioid therapy (Endometriosis is allowed unless the patient is on chronic daily opioids).
- History of substance abuse (alcohol or drugs).
- Severe respiratory disease (e.g., COPD) or sleep apnea.
- Uncontrolled psychiatric disorders or severe anxiety preventing cooperation with the procedure.
- Natural Cycle / IVM: OPU scheduled for a natural cycle, modified natural cycle, or In-Vitro Maturation (IVM) cycle (typically involving low follicle count/single puncture).
- Freeze-All' Indication: Cycles where a 'freeze-all' strategy is planned specifically due to a high risk of Ovarian Hyperstimulation Syndrome (OHSS) (defined as > 20 follicles on ultrasound), to avoid confounding pain scores with OHSS symptoms.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.