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Study of sufentanil versus midazolam for pain relief during egg retrieval in women undergoing fertility treatment

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at pain management during a procedure called oocyte pick-up, which is an egg collection procedure performed as part of fertility treatment. During this procedure, eggs are removed from the ovaries using a needle guided through the vagina, and it can cause pain. The study will test whether a medication called sufentanil, given as a tablet that dissolves under the tongue, can reduce pain better than the current standard treatment that uses midazolam. The standard treatment may also include other pain relief medications such as paracetamol, alprazolam, lidocaine, and diclofenac. The purpose of the study is to find out if sufentanil reduces pain during the egg collection procedure compared to the standard treatment.

Women taking part in the study will be divided into two groups. One group will receive sufentanil before the procedure, while the other group will receive the standard treatment with midazolam. During the egg collection procedure, pain levels will be measured every two minutes using a pain scale where participants mark their pain level on a line. The study will also look at how satisfied participants are with their pain management about one day after the procedure, how much pain they feel in the recovery area and at home, whether they need to take additional pain medication at home, and whether they experience side effects such as nausea, vomiting, or breathing problems.

After the procedure, participants will be monitored in a recovery area before going home. They will be contacted about one day later to answer questions about their pain, satisfaction with pain management, any side effects, and any additional pain medication they took at home. The study will also collect information about the procedure itself, such as how long it took, how many eggs were collected, and certain hormone levels measured before and after the procedure. Information about whether pregnancy occurs will also be collected.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Pre-procedure preparation
Two days before the egg collection procedure, blood samples will be taken to measure hormone levels including estradiol, FSH (follicle stimulating hormone), LH (luteinizing hormone), progesterone, and the number of follicles will be counted.
Before the procedure begins, any nausea or vomiting will be assessed and recorded.
Step 2
Pain management medication administration
Depending on the assigned treatment group, one of the following medication regimens will be administered before the egg collection procedure:
Option 1: A single dose of sufentanil 30 micrograms will be placed under the tongue (sublingual tablet) before the procedure starts.
Option 2: The standard pain management regimen will be used, which includes midazolam given as an injection into the muscle (intramuscular injection).
Additional medications may be used during the procedure as needed, including lidocaine (a local numbing medication) given by infiltration (injection into the tissue).
Step 3
During the egg collection procedure
The egg collection procedure will be performed through the vagina (transvaginal oocyte pick-up).
Pain levels will be assessed every two minutes throughout the entire procedure using a scale from 0 to 100 millimeters (VAS scale), where 0 means no pain and 100 means the worst pain imaginable.
Breathing rate, oxygen levels in the blood (SpO₂), and any side effects will be monitored continuously during the procedure.
The duration of the procedure and the number of eggs collected will be recorded.
Step 4
Immediate recovery period
Upon arrival in the recovery area (T0), pain level will be assessed using the same 0 to 100 scale.
Pain levels will be checked again at 30 minutes and 1 hour after the procedure.
Any nausea or vomiting will be recorded at these time points.
The amount of vaginal bleeding will be assessed and compared to what is usual (less, usual, or more than usual).
The time until discharge from the facility will be recorded.
Step 5
At-home recovery and follow-up within 24 hours
Pain relief medications that may be taken at home include paracetamol (available as 1 gram film-coated tablets taken by mouth), alprazolam (available as 0.5 milligram tablets taken by mouth), or diclofenac sodium (available as 75 milligram prolonged-release tablets taken by mouth).
The type and amount of any pain medication taken at home within the first 24 hours should be recorded.
Any nausea or vomiting experienced at home will be recorded.
Approximately 24 hours after the procedure, satisfaction with pain management will be assessed using a standardized questionnaire (APS-POQ-R).
Step 6
Two weeks after embryo transfer
A blood test will be performed two weeks after embryo transfer to measure HCG (human chorionic gonadotropin), a hormone that indicates pregnancy.
Step 7
Pregnancy confirmation
Approximately 7 weeks after embryo transfer, clinical pregnancy will be confirmed through standard assessment.

Who can join the trial?

4 criteria

You must be an adult woman who is undergoing IVF/ART (a fertility treatment where eggs are collected from your ovaries to help you become pregnant) with a planned egg collection procedure through the vagina.
You must be able to understand the study information, give your permission to take part, and follow the study steps, which include rating your pain during the egg collection and a follow-up check 24 hours later.
You must have an ASA physical status of I to III. This is a rating system doctors use to describe your overall health before a procedure. ASA I means you are healthy, ASA II means you have mild health problems that are well controlled, and ASA III means you have more serious health conditions that are stable. You must be suitable for the sedation and pain relief methods normally used at the clinic for egg collection.
You must meet the clinic's safety requirements for having the egg collection procedure as an outpatient, meaning you can go home the same day. These requirements include checks of your airway, your BMI (body mass index, which is a measure of your weight compared to your height), and any other health conditions you may have, according to the clinic's standard procedures.

Who cannot join the trial?

1 criterion

No exclusion criteria have been specified for this clinical trial in the provided information.

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Verified sites

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Vrije Universiteit Brussel
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Jette, Belgium

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Investigated drugs

Sufentanil
is a strong pain medication that is placed under the tongue to dissolve. It works by blocking pain signals in your body and brain. In this trial, it is being tested to see if it can reduce pain during the egg collection procedure that is part of fertility treatment.
Midazolam
is a medication that helps you feel calm and relaxed during medical procedures. It belongs to a group of medicines that reduce anxiety and can make you feel drowsy. In this trial, it is being used as the standard treatment to compare against the new pain medication.

What is already known about the treatment

Dzuveo – Dzuveo is a pain medication containing sufentanil that is placed under the tongue (sublingual form) and dissolves there to be absorbed into the bloodstream. It is being studied as a pain management option for women undergoing egg retrieval during fertility treatments, which can be an uncomfortable procedure. The medication works by attaching to specific receptors in the brain and spinal cord called opioid receptors, which block pain signals from being processed by the nervous system. Dzuveo belongs to a class of medications known as opioid analgesics, which are strong pain relievers used for managing moderate to severe pain in medical settings.

Investigated diseases

Acute Procedural Pain – Acute procedural pain is a type of short-term pain that occurs during medical procedures. In this case, it specifically refers to pain experienced during oocyte pick-up, which is a step in fertility treatment where eggs are retrieved from the ovaries. The pain begins when the needle first punctures the tissue and continues throughout the egg collection process. This type of pain is temporary and directly related to the medical procedure being performed. The intensity of pain can vary between patients and may occur at multiple points during the procedure. The pain typically resolves after the procedure is completed.