NCT07536425

Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients

Evaluating the Efficacy of Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients A Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled trial evaluating the efficacy of preoperative analgesic medications - Indomethacin (100 mg per rectum) and Paracetamol/Acamol (1,000 mg intravenously) - for pain management during oocyte retrieval in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Detailed description

Pain during oocyte retrieval is one of the most commonly reported concerns among women undergoing assisted reproductive technology (ART). The procedure involves transvaginal ultrasound-guided aspiration of ovarian follicles, which causes pain through needle puncture of ovarian and surrounding tissues. Adequate analgesia is essential not only for patient comfort but also to minimize procedural stress, reduce the need for deeper sedation, shorten recovery time, and potentially improve treatment outcomes. Existing analgesic approaches - including paracervical blocks, conscious sedation, and general anesthesia - carry limitations such as hemodynamic risks, prolonged recovery, and increased resource requirements. Randomized controlled trial (RCT) evidence on non-invasive preoperative analgesics for this indication remains limited and methodologically heterogeneous. This study is a three-arm, randomized, controlled trial comparing two preoperative analgesic regimens against a no-premedication control group in women undergoing oocyte retrieval under standard anesthesia at the IVF Unit, Galilee Medical Centre. Participants will be randomized to one of three groups: Group 1: Indomethacin 100 mg per rectum, administered prior to oocyte retrieval Group 2: Paracetamol (Acamol) 1,000 mg intravenously, administered prior to oocyte retrieval Group 3 (Control): No active preoperative analgesic medication All participants will undergo oocyte retrieval under standard anesthesia protocols. Pain will be assessed using the Numerical Rating Scale (NRS) immediately post-procedure, every 15 minutes for 2 hours, prior to discharge, and again 3 days after the procedure. Patient satisfaction, side effects, need for rescue analgesia, IVF success rates, and cost-effectiveness will also be recorded. The study adheres to Good Clinical Practice (GCP) guidelines. All participants will provide written informed consent prior to enrollment. The protocol has been reviewed and approved by the relevant institutional ethics committee (Protocol No. 0240-24-NHR)

Conditions

• Pain
• Oocyte Retrieval

Interventions

Type	Name	Description
DRUG	Indomethacin 100Mg Suppository	Indomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group
DRUG	Paracetamol / Acetaminophen	Paracetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval.

Timeline

• Start date: 2026-04-13
• Primary completion: 2026-10-30
• Completion: 2026-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Israel