Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indomethacin 100Mg Suppository, Paracetamol / Acetaminophen.
- Who it may be relevant to
- Registry conditions: Pain, Oocyte Retrieval. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Efficacy of Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients A Randomized Controlled Study
Overview
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)
Interventions
- 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.
Primary outcome measures
- Postoperative Pain Intensity [Time frame: From immediately post-procedure up to 3 days after oocyte retrieval]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Western Galilee Hospital, IVF unit — Nahariya
Publications
- 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
- 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
- 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
Identifiers
NCT: NCT07536425 · 0240-24-NHR