PainPhase 4NCT07536425
Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients
A Phase 4 study testing Indomethacin 100Mg Suppository and Paracetamol / Acetaminophen in people with Pain and Oocyte Retrieval, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Oocyte Retrieval
- What is being tested?
- Indomethacin 100Mg Suppository and Paracetamol / Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Apr 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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)
- Conditions
- Pain, Oocyte Retrieval
- Being tested
- Indomethacin 100Mg Suppository, Paracetamol / Acetaminophen
- Keywords
- Oocyte retrieval, IVF, ICSI, Pain management, Assisted reproductive technology, Numerical Rating Scale
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin 100Mg SuppositoryDrug
Indomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group
Paracetamol / AcetaminophenDrug
Paracetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin Group | Experimental | Participants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval. Receives: 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 Receives: Drug: Paracetamol / Acetaminophen |
| Control Group | No intervention | Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From immediately post-procedure up to 3 days after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 177 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, raneen sawaid, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536425
- Sponsor's protocol ID
- 0240-24-NHR
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
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.
PubMed 35224230Vlahos 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.
PubMed 19249049Thanikachalam 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.
PubMed 37305768
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Preoperative Indomethacin and Paracetamol for Pain Management During Oocyte Retrieval in IVF Patients A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07536425
- Acronym / sponsor ID
- 0240-24-NHR
- Conditions
- Pain, Oocyte Retrieval
- Keywords
- Oocyte retrieval, IVF, ICSI, Pain management, Assisted reproductive technology, Numerical Rating Scale
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 177 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Indomethacin Group | Experimental | Drug: Indomethacin 100Mg SuppositoryParticipants receive Indomethacin 100 mg per rectum, administered after induction of anesthesia prior to oocyte retrieval. |
| Paracetamol Group | Experimental | Drug: Paracetamol / AcetaminophenParticipants receive Paracetamol (Acamol) 1,000 mg intravenously, administered after induction of anesthesia prior to oocyte retrieval. Paracetamol Group |
| Control Group | No intervention | –Participants receive no active preoperative analgesic medication. Oocyte retrieval is performed under standard anesthesia protocols only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indomethacin 100Mg SuppositoryIndomethacin 100 mg administered per rectum after induction of anesthesia, prior to oocyte retrieval. Indomethacin Group | Drug | Indomethacin Group |
| Paracetamol / AcetaminophenParacetamol (Acamol) 1,000 mg administered intravenously after induction of anesthesia, prior to oocyte retrieval. | Drug | Paracetamol Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 35224230Buisman 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.
- Background: PubMed 19249049Vlahos 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.
- Background: PubMed 37305768Thanikachalam 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indomethacin 100Mg Suppository and Paracetamol / Acetaminophen in people with Pain and Oocyte Retrieval, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raneen Sawaid Kaiyal, Medical Doctor (+972502044422, raneen.sawaid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: From immediately post-procedure up to 3 days after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07536425, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.