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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00853177
Recruitment Status : Completed
First Posted : March 2, 2009
Last Update Posted : September 18, 2012
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
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 or disease Intervention/treatment Phase
Infertility Pain Procedure: MEOPA inhalation Procedure: xylocaine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study
Study Start Date : November 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arm Intervention/treatment
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

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
PubMed  This link exits the site

Publications of Results:
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00853177     History of Changes
Other Study ID Numbers: P070304
First Posted: March 2, 2009    Key Record Dates
Last Update Posted: September 18, 2012
Last Verified: May 2011

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