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Completed

NCT Number: NCT00853177

MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet

Bondy, Île-de-France Region, 93143, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEOPA inhalation

Procedure

N2O of 50% and 50% O2

xylocaine

Procedure

Ampoule-bottle of 20 ml

Other names: local anesthesia

Primary outcomes

  1. Pain after oocyte retrieval at + 30, 60 and 120 minutes.

    Time frame: immediate (at + 30, 60 and 120 minutes)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study

Acronym: KALOVAL

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 2, 2009
Registry last updated
Sep 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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