Evaluation of a New Pain Management Regime for Oocyte Pick-Up During Fertility Treatment

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Brussel

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Decision date (initial)

2026-01-22

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

UZ Brussel

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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.

Secondary objectives 5

1. To compare time to readiness for discharge after OPU between study arms.
2. To compare patient satisfaction with pain management at ~24 h post-procedure (APS-POQ-R).
3. To compare rescue analgesic use during OPU and within 24 h post-procedure.
4. To compare adverse events (e.g., oxygen desaturation, respiratory depression, nausea/vomiting, excessive sedation) between arms.
5. To explore procedure/fertility outputs, including number of oocytes retrieved and early clinical pregnancy rate (if measured).

Conditions and MedDRA coding

Acute procedural pain associated with oocyte pick-up (oocyte retrieval) in women undergoing IVF/ART.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Female adult undergoing IVF/ART with a planned transvaginal oocyte pick-up at UZ Brussel.
2. Able to provide informed consent and comply with study procedures (pain ratings during OPU; 24-h follow-up).
3. ASA physical status I–III under institutional OPU sedation/analgesia pathways.
4. Meets institutional safety thresholds for ambulatory OPU (e.g., airway assessment, BMI and comorbidity limits) per site SOPs.

Exclusion criteria 10

1. Known allergy or hypersensitivity to Sufentanil, Midazolam, Paracetamol, Diclofenac, Alprazolam, Piritramide, or any excipients of these products.
2. Current use of MAOIs or within 14 days pre-OPU.
3. History of substance abuse (opioids/benzodiazepines) within the past year.
4. Pre-existing chronic pain conditions requiring chronic opioid therapy (Endometriosis is allowed unless the patient is on chronic daily opioids).
5. History of substance abuse (alcohol or drugs).
6. Severe respiratory disease (e.g., COPD) or sleep apnea.
7. Uncontrolled psychiatric disorders or severe anxiety preventing cooperation with the procedure.
8. 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).
9. 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.
10. Inability to understand the study procedures or the local languages (Dutch/French/English) sufficiently to complete the questionnaires.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall intra-procedural pain intensity during OPU, VAS 0–100 mm recorded every 2 minutes from first puncture to completion; primary derived measure (mean/median or VAS-AUC over time) per SAP.

Secondary endpoints 8

1. Patient satisfaction with pain management at ~24 h post-OPU using APS-POQ-R.
2. Post-OPU VAS pain at T0 (arrival in recovery), 30 min, 1 h, and discharge.
3. Rescue analgesic use at home within 24 h (type/amount).
4. Nausea/vomiting incidence: pre-OPU, immediate post-OPU, 30 min, 1 h, discharge, and at 24 h.
5. Respiratory depression/other AEs during and immediately after OPU (SpO₂, RR, clinical observation).
6. Vaginal bleeding (usual/less/more than usual).
7. Recovery metrics: time to discharge, procedure duration, number of oocytes retrieved, operator experience level.
8. Hormonal/fertility markers: E2/FSH/LH/progesterone and follicle count (2 days pre-OPU); HCG 2 weeks post-ET; clinical pregnancy at ~7 weeks.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Brussel

Sponsor organisation

UZ Brussel

Address

Laarbeeklaan 101

City

Jette

Postcode

1090

Country

Belgium

Scientific contact point

Organisation

UZ Brussel

Contact name

Annelies Scholliers

Public contact point

Organisation

UZ Brussel

Contact name

Annelies Scholliers

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications