MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Pain
Intervention: MEOPA inhalation (Procedure); xylocaine (Procedure)
Phase: Phase 4
Status: Recruiting
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Christophe Poncelet, MD PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Overall contact:
Christophe Poncelet, MD PhD, Phone: +33(0)148 02 67 64, Email: christophe.poncelet@jvr.aphp.fr
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.
Clinical Details
Official title: MEOPA Breathing Analgesia vs Local Anesthesia for Oocyte Retrieval in ART: a Prospective, Randomized Controlled Study
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain after oocyte retrieval at + 30, 60 and 120 minutes.
Secondary outcome: Patients satisfaction at time + 120 minutes.Patients recommendation at time + 120 minutes.
Patients with supplementary analgesics at time + 120 minutes. Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactiv Oxygen Species in retrieved follicular fluid.
Detailed description:
Oocyte retrieval is a major event during 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
Minimum age: 18 Years.
Maximum age: 42 Years.
Gender(s): Female.
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:
- absolut indication for oocyte retrieval with general anesthesia
- no agreement to participate to this study,
- painfully known patient-not easy ovarian vaginal accessibibility for monitoring or
puncture
- respiratory pathology-chronic liver, kidney pathology, immunodeficiency, - contraindication to the medications used during the protocol
Locations and Contacts
Christophe Poncelet, MD PhD, Phone: +33(0)148 02 67 64, Email: christophe.poncelet@jvr.aphp.fr
Hôpital Jean Verdier, service de la médecine de la reproduction, avenue du 14 juillet, Bondy, Ile de France 93143, France; Recruiting
Christophe PONCELET, MD PhD, Phone: 00-33(1)48026764, Email: christophe.poncelet@jvr.aphp.fr
christophe PONCELET, Professor, Principal Investigator
Additional Information
PubMed
Starting date: December 2008
Ending date: December 2010
Last updated: February 27, 2009
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