MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00853177
First received: February 6, 2009
Last updated: September 15, 2012
Last verified: May 2011
  Purpose

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
Infertility
Pain
Procedure: MEOPA inhalation
Procedure: xylocaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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) ] [ Designated as safety issue: Yes ]

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

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

MEOPA

Procedure: MEOPA inhalation
N2O of 50% and 50% O2
Other Name: MEOPA inhalation
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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853177

Locations
France
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
Investigators
Principal Investigator: Christophe Poncelet, MD PhD Assistance Publique - Hôpitaux de Paris
  More Information

Additional Information:
PubMed  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00853177     History of Changes
Other Study ID Numbers: P070304
Study First Received: February 6, 2009
Last Updated: September 15, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 24, 2014