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

ConditionsPain Oocyte Retrieval

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorWestern Galilee Hospital-Nahariya

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women undergoing oocyte retrieval for IVF or ICSI

Age 18-45 years

ASA physical status classification I or II

Willing and able to provide written informed consent

Disqualifiers

Known allergy or hypersensitivity to Indomethacin, any NSAID, or Paracetamol

History of gastrointestinal bleeding or peptic ulceration

Renal impairment (GFR < 30 ml/min/1.73m² or Creatinine > 1.04 mg/dL)

Hepatic impairment (ALT > 55 U/L, AST > upper limit of normal, ALP > upper limit of normal, Total Bilirubin > 1.2 mg/dL, or Albumin < 3.5 g/dL)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

177 Participants

are divided into 3 treatment groups

Group A: Indomethacin GroupExperimental treatment 1 intervention

Group B: Paracetamol GroupExperimental treatment 1 intervention

Group C: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Western Galilee Hospital-Nahariya

Lead sponsor

Source ClinicalTrials.gov

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