A Phase 4 interventional study of Indomethacin 100Mg Suppository and Paracetamol / Acetaminophen in Pain and Oocyte Retrieval, sponsored by Western Galilee Hospital-Nahariya. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Western Galilee Hospital-Nahariya · Phase 4, Interventional, and Treatment
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).
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)
Exclusion Criteria:
Participants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval.
Drug: Indomethacin 100Mg Suppository
Participants receive Paracetamol (Acamol) 1,000 mg intravenously, administered after induction of anesthesia prior to oocyte retrieval. Paracetamol Group
Drug: Paracetamol / Acetaminophen
Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only.
Indomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group
Paracetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval.
Postoperative Pain Intensity
Pain intensity assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain. Pain is measured immediately after the procedure, every 15 minutes for 2 hours post-retrieval, prior to discharge, and 1-3 days after oocyte retrieval. Scores are compared across the three study arms.
Time frame: From immediately post-procedure up to 3 days after oocyte retrieval
Plan to share: Undecided — Individual participant data sharing has not yet been determined. Decisions regarding IPD sharing will be made following study completion, ethical review, and in accordance with the data protection policies of Galilee Medical Centre and applicable Israeli privacy regulations. Requests for data sharing may be considered on a case-by-case basis.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Western Galilee Hospital-Nahariya