Меню
Набор скоро начнётся NCT07536425

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

Фаза IV С лечением Pain Oocyte Retrieval

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Indomethacin 100Mg Suppository, Paracetamol / Acetaminophen.
Кому может быть актуально
Состояния в реестре: Pain, Oocyte Retrieval. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Израиль
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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).

Подробное описание

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)

Вмешательства

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

Первичные конечные точки

  • Postoperative Pain Intensity [Срок оценки: From immediately post-procedure up to 3 days after oocyte retrieval]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Израиль · 1 центр
  • Western Galilee Hospital, IVF unit — Nahariya

Публикации

  • 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

Идентификаторы

NCT: NCT07536425 · 0240-24-NHR

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗