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MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00853177
Acronym
KALOVAL
Enrollment
77
Registered
2009-03-02
Start date
2008-11-30
Completion date
2011-01-31
Last updated
2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Pain

Keywords

Oocyte retrieval, pain, surgery, anaesthesiology, Assisted Reproductive Technologies

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.

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.

Interventions

PROCEDUREMEOPA inhalation

N2O of 50% and 50% O2

PROCEDURExylocaine

Ampoule-bottle of 20 ml

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
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

Design outcomes

Primary

MeasureTime frame
Pain after oocyte retrieval at + 30, 60 and 120 minutes.immediate (at + 30, 60 and 120 minutes)

Secondary

MeasureTime frame
Patients satisfaction at time + 120 minutes.immediate (at + 120 minutes)
Patients recommendation at time + 120 minutes. Patients with supplementary analgesics at time + 120 minutes.immediate (at time + 120 minutes)
Patients with canceled protocol arm attribution during oocyte retrievalART already stated issues Reactive Oxygen Species in retrieved follicular fluid.immediate

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026