MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility, Pain

Intervention / Treatment
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* Procedure: MEOPA inhalation
* Procedure: xylocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitrous oxide<br>N2O of 50% and 50% O2 MEOPA | Procedure: MEOPA inhalation<br>* N2O of 50% and 50% O2<br>|
| Active Comparator: lidocaine<br>Injection solution 1% | Procedure: xylocaine<br>* Ampoule-bottle of 20 ml<br>* Other names: local anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after oocyte retrieval at + 30, 60 and 120 minutes. |  | immediate (at + 30, 60 and 120 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oocyte retrieval, pain, surgery, anaesthesiology, Assisted Reproductive Technologies