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

NCT07536425 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 0240-24-NHR
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain; Oocyte Retrieval

Keywords

Oocyte retrieval; IVF; ICSI; Pain management; Assisted reproductive technology; Numerical Rating Scale

Outcome Measures

Primary Outcomes (1)

• 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.

  From immediately post-procedure up to 3 days after oocyte retrieval

Study Arms (3)

Indomethacin Group

EXPERIMENTAL

Participants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval.

Drug: Indomethacin 100Mg Suppository

Paracetamol Group

EXPERIMENTAL

Participants receive Paracetamol (Acamol) 1,000 mg intravenously, administered after induction of anesthesia prior to oocyte retrieval. Paracetamol Group

Drug: Paracetamol / Acetaminophen

Control Group

NO INTERVENTION

Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only.

Interventions

Indomethacin 100Mg Suppository DRUG

Indomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group

Indomethacin Group

Paracetamol / Acetaminophen DRUG

Paracetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval.

Paracetamol Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Participation in another clinical trial that may interfere with the outcomes of this study

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital, IVF unit

Nahariya, Israel

Location

Related Publications (3)

• Buisman ETIA, Grens H, Wang R, Bhattacharya S, Braat DDM, Huppelschoten AG, van der Steeg JW. Trends in research on pain relief during oocyte retrieval for IVF/ICSI: a systematic, methodological review. Hum Reprod Open. 2022 Feb 16;2022(1):hoac006. doi: 10.1093/hropen/hoac006. eCollection 2022.

  PMID: 35224230 BACKGROUND

• Vlahos NF, Giannakikou I, Vlachos A, Vitoratos N. Analgesia and anesthesia for assisted reproductive technologies. Int J Gynaecol Obstet. 2009 Jun;105(3):201-5. doi: 10.1016/j.ijgo.2009.01.017. Epub 2009 Feb 26.

  PMID: 19249049 BACKGROUND

• Thanikachalam P, Govindan DK. Pain Management during Ultrasound Guided Transvaginal Oocyte Retrieval - A Narrative Review. J Hum Reprod Sci. 2023 Jan-Mar;16(1):2-15. doi: 10.4103/jhrs.jhrs_141_22.

  PMID: 37305768 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Indomethacin; Suppositories; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Raneen Sawaid Kaiyal, Medical Doctor

CONTACT

+972502044422; raneen.sawaid@gmail.com

Inbal Paskovetich

CONTACT

9724 9107267; inbalp@gmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to their treatment allocation. All interventions (Indomethacin per rectum, Paracetamol IV, or no medication) are administered after induction of anesthesia, so participants are unaware of the treatment they received. Investigators and clinical staff are not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Fertility Specialist and head of fertility preservation unit

Model Details: This is a three-arm, single-blind, randomized controlled trial. Participants undergoing oocyte retrieval for IVF/ICSI are randomly assigned using a computer-generated randomization list to one of three parallel groups: (1) Indomethacin 100 mg per rectum administered preoperatively, (2) Paracetamol 1,000 mg intravenously administered preoperatively, or (3) no active preoperative analgesia (control). All participants undergo oocyte retrieval under standard anesthesia protocols. Participants are blinded to their treatment allocation.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

IL (1)