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MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL) (KALOVAL)

This study has been completed.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris Identifier:
First received: February 6, 2009
Last updated: September 15, 2012
Last verified: May 2011
The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.

Condition Intervention Phase
Procedure: MEOPA inhalation
Procedure: xylocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study

Resource links provided by NLM:

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Pain after oocyte retrieval at + 30, 60 and 120 minutes. [ Time Frame: immediate (at + 30, 60 and 120 minutes) ]

Secondary Outcome Measures:
  • Patients satisfaction at time + 120 minutes. [ Time Frame: immediate (at + 120 minutes) ]
  • Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes. [ Time Frame: immediate (at time + 120 minutes) ]
  • Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid. [ Time Frame: immediate ]

Enrollment: 77
Study Start Date: November 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nitrous oxide

N2O of 50% and 50% O2


Procedure: MEOPA inhalation
N2O of 50% and 50% O2
Active Comparator: lidocaine
Injection solution 1%
Procedure: xylocaine
Ampoule-bottle of 20 ml
Other Name: local anesthesia

Detailed Description:
Oocyte retrieval is a major event during in VITRO-fertilization, with or without sperm micro-injection. Initially done by laparoscopy with general anesthesia, the oocyte collection is now carried out by trans-vaginal controlled ultrasound puncture. This potential painful event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary, requires analgesia or anesthesia. General anesthesia is certainly effective in terms of collected oocytes. It remains, however, a heavy time consumer, with personal risks and distributor of anesthetic agents in blood or follicular fluid. These products could have a deleterious effect on early embryonic development or implantation. Few data are available concerning these risks in the literature. General anesthesia is still essential for pusillanimous patients or for patients with a heavy surgical past. Nitrous oxide is an inhaled gas with properties widely used in obstetric during parturition. It is regularly used during general anesthesia performed for oocyte retrieval. With a gas composed of 50% N2O and 50% O2, its main interest is to provide analgesia in a state of conscious sedation. The effects of nitrous oxide in this form had never been assessed on the clinical or biological Oocyte collection. We conducted a preliminary study to assess pain in patients receiving local anesthesia, according the current protocol. Thus, 44% of patients had severe pain (VAS> 40/100) during or just after transvaginal oocyte retrieval. In our preliminary experience, immediate or distance post-operative pain was high and we plan to evaluate the benefit of analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective, randomized and controlled study as compared with local anesthesia associated to Alprazolam.

Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patient requiring a first or second oocyte retrieval procedure for IVR or ICSI after ovarian stimulation by gonadotrophin
  • agreement to participate to this study

Exclusion Criteria:

  • absolute indication for oocyte retrieval with general anesthesia
  • no agreement to participate to this study,
  • painfully known patient-not easy ovarian vaginal accessibility for monitoring or puncture
  • respiratory pathology-chronic liver, kidney pathology, immunodeficiency, -contraindication to the medications used during the protocol
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Please refer to this study by its identifier: NCT00853177

Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet
Bondy, Ile de France, France, 93143
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Christophe Poncelet, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
PubMed  This link exits the site

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00853177     History of Changes
Other Study ID Numbers: P070304
Study First Received: February 6, 2009
Last Updated: September 15, 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Oocyte retrieval
Assisted Reproductive Technologies

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 21, 2017