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

April 27, 2026 updated by: raneen sawaid, Western Galilee Hospital-Nahariya

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

177

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Nahariya, Israel
        • Western Galilee Hospital, IVF unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Indomethacin Group
Participants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval.
Drug: Indomethacin 100Mg Suppository
Indomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group
Experimental: Paracetamol Group
Participants receive Paracetamol (Acamol) 1,000 mg intravenously, administered after induction of anesthesia prior to oocyte retrieval. Paracetamol Group
Drug: Paracetamol / Acetaminophen
Paracetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval.
No Intervention: Control Group
Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: From immediately post-procedure up to 3 days after oocyte retrieval
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Galilee Hospital-Nahariya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 13, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

April 10, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0240-24-NHR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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