InfertilityNCT03362021
Comparison of Two Different Sedation Protocols During Transvaginal Oocyte Retrieval
An observational study of Infertility, run by Attikon Hospital at 1 site in Greece.
Trial summary
The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- transvaginal oocyte retrieval
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jan 2018to 20 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: eligible females scheduled for oocyte retrieval
Who may be able to join
- female patients between 25 and 45 years old that do not meet any of the exclusion criteria
Who cannot join
- patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.
Read the detailed description
Women will be consecutively allocated into one of the following two groups using a 1:1 ratio in order to avoid any potential source of bias.
Group DEX: women will receive dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of procedure. At that time point, both total volume (ml) and dose (γ) of dexmedetomidine administered will be recorded.
Group MZM: women will receive remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min και midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. At that time point, both total volume (ml) and dose (γ) of remifentanil administered will be recorded.
In both groups, in case of non-co-operation of the woman (e.g. kinetic response), propofol will be given as a bolus rescue dose as follows: the 1st rescue dose will be 1mg/kg while all the next doses will be 0.5 mg/kg. At the end of the procedure, the number of rescue doses and the total rescue dose (mg) of propofol given will be recorded.
Intraoperative monitoring will include ECG, noninvasive blood pressure, SpO2, EtCO2 and depth of sedation using BIS values and ΟΑSS scale. Also, adverse effects such as hypotension, bradycardia, nausea \& vomiting, rigidity, airway obstruction, and need for bag-mask ventilation will be recorded. The use of vasoactive drugs will also be reported.
At the end of the procedure, the time and quality of recovery will be assessed using ΟΑSS scale (max score=5), while postoperatively the Post Anesthesia Discharge Scoring System, as well as woman's and gynecologist's (physician) overall satisfaction related to the sedation techniques used, will be recorded.
Regarding the IVF outcome, the following parameters will be recorded: number of oocytes retrieved, the percentage of mature oocytes, embryo quality, percentage of positive pregnancy test, percentage of clinical pregnancy, the percentage of live birth.
- Conditions
- Infertility
- Being tested
- transvaginal oocyte retrieval
- Keywords
- transvaginal oocyte retrieval, sedation, dexmedetomidine, fentanyl, remifentanil, midazolam
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal oocyte retrievalProcedure or surgery
sedation for oocyte retrieval
| Study group | Role | What they receive |
|---|---|---|
| DEX | Sedation with dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. Receives: Procedure: transvaginal oocyte retrieval | |
| MZM | Sedation with remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min and midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. Receives: Procedure: transvaginal oocyte retrieval |
What is being measured
The primary outcome is the main question the study is designed to answer.
propofol consumption
difference >30% in propofol consumption
Measured: from the beginning to the end of the transvaginal oocyte retrieval procedure
Secondary outcomes (21)
number of oocytes retrieved
Measured: up to 3 weeks after starting ovarian stimulation treatment
percentage of mature oocytes
Measured: up to 3 weeks after starting ovarian stimulation treatment
fertilization rate
Measured: up to 3 weeks after starting ovarian stimulation treatment
embryo quality
Embryo quality for endometrial transfer or cryopreservation will be assessed according to morphological criteria based on the overall blastomere number, size, appearance and degree of fragmentation
Measured: up to 4 weeks after starting ovarian stimulation treatment
positive pregnancy test
Measured: up to 3 weeks after transvaginal oocyte retrieval
clinical pregnancy
confirmed presence of an intrauterine sac with fetal heart activity through transvaginal ultrasound scan at seven weeks of gestation, following a positive serum β-hCG test
Measured: up to 12 weeks after starting ovarian stimulation treatment
Live birth
birth of a live fetus after 20 weeks of gestation
Measured: up to 24 weeks after starting ovarian stimulation treatment
BIS score
bispectral index score
Measured: assessed every 5 minutes during transvaginal oocyte retrieval procedure
Observer's Assessment of Alertness/Sedation scale - OAA/S scale
used to assess level of sedation during the procedure (5- Responds readily to name spoken in normal tone, 4-Lethargic response to name spoken in normal tone, 3-Responds only after name is called loudly and/or repeatedly, 2-Responds only after mild prodding or shaking, 1-Does not respond to mild prodding or shaking
Measured: assessed every 5 minutes during transvaginal oocyte retrieval procedure
airway obstruction
(yes/no)
Measured: during the procedure
need to ventilate by mask
yes/no
Measured: during the procedure
presence of muscle rigidity
yes/no
Measured: during the procedure
presence of bradycardia (heart rate less than 50 bpm)
Measured: during the procedure
hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure
Measured: during the procedure
dexmedetomidine consumption
total μg
Measured: from the beginning to the end of the transvaginal oocyte retrieval procedure
remifentanil consumption
total μg
Measured: from the beginning to the end of the transvaginal oocyte retrieval procedure
vasoactive drug consumption
Measured: from the beginning to the end of the transvaginal oocyte retrieval procedure
patient satisfaction score
4 point scale (0-poor, 1-good, 2-very good, 3-excellent)
Measured: end of procedure
physician satisfaction score
4 point scale (0-poor, 1-good, 2-very good, 3-excellent)
Measured: end of procedure
presence of nausea or vomitus
0-none, 1-nausea, 2-vomitus<2, 3 vomitus>2
Measured: from end of procedure to discharge from hospital, approximately 4 hours after procedure
Post Hospital Discharge Score
time required by patient to be able to return at home
Measured: from end of procedure to discharge from hospital, approximately 4 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start5 Jan 2018
- Primary completion20 Nov 2019
- Study completion20 Nov 2019
Why it stopped: Primary investigator transferred in another hospital; ongoing pandemic;
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362021
- Sponsor's protocol ID
- TORDEX
- Status last verified
- Sep 2020
- First submitted
- 5 Nov 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Sedation Protocol During Transvaginal Oocyte Retrieval: Effects on Propofol Consumption
- ClinicalTrials.gov ID
- NCT03362021
- Acronym / sponsor ID
- TORDEX
- Conditions
- Infertility
- Keywords
- transvaginal oocyte retrieval, sedation, dexmedetomidine, fentanyl, remifentanil, midazolam
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Primary investigator transferred in another hospital; ongoing pandemic;
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 5 Jan 2018 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effects of two different sedation protocols during transvaginal oocyte retrieval will be investigated on propofol consumption as a rescue sedative and on IVF success. One group will receive dexmedetomidine and fentanyl while the other will receive midazolam and remifentanil.
Detailed description
Women will be consecutively allocated into one of the following two groups using a 1:1 ratio in order to avoid any potential source of bias.
Group DEX: women will receive dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of procedure. At that time point, both total volume (ml) and dose (γ) of dexmedetomidine administered will be recorded.
Group MZM: women will receive remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min και midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. At that time point, both total volume (ml) and dose (γ) of remifentanil administered will be recorded.
In both groups, in case of non-co-operation of the woman (e.g. kinetic response), propofol will be given as a bolus rescue dose as follows: the 1st rescue dose will be 1mg/kg while all the next doses will be 0.5 mg/kg. At the end of the procedure, the number of rescue doses and the total rescue dose (mg) of propofol given will be recorded.
Intraoperative monitoring will include ECG, noninvasive blood pressure, SpO2, EtCO2 and depth of sedation using BIS values and ΟΑSS scale. Also, adverse effects such as hypotension, bradycardia, nausea \& vomiting, rigidity, airway obstruction, and need for bag-mask ventilation will be recorded. The use of vasoactive drugs will also be reported.
At the end of the procedure, the time and quality of recovery will be assessed using ΟΑSS scale (max score=5), while postoperatively the Post Anesthesia Discharge Scoring System, as well as woman's and gynecologist's (physician) overall satisfaction related to the sedation techniques used, will be recorded.
Regarding the IVF outcome, the following parameters will be recorded: number of oocytes retrieved, the percentage of mature oocytes, embryo quality, percentage of positive pregnancy test, percentage of clinical pregnancy, the percentage of live birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX | – | Procedure: transvaginal oocyte retrievalSedation with dexmedetomidine (solution 4 γ/ml) continuously infused at a dose of 1 γ/kg/ and fentanyl 100γ iv. Dexmedetomidine infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. |
| MZM | – | Procedure: transvaginal oocyte retrievalSedation with remifentanil (solution 50γ/ml) continuously infused at a dose of 0.2 γ/kg/min and midazolam 1 mg iv. Remifentanil infusion will start 10 min before the start of transvaginal oocyte retrieval and will stop at the end of the procedure. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- eligible females scheduled for oocyte retrieval
Key inclusion criteria (1 listed)
- female patients between 25 and 45 years old that do not meet any of the exclusion criteria
Key exclusion criteria (1 listed)
- patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class >2, severe hypotension or bradycardia, presence of atrioventricular block, cerebrovascular disease or hepatic dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal oocyte retrievalsedation for oocyte retrieval | Procedure or surgery | DEX, MZM |
Primary outcome
propofol consumption
Time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
difference >30% in propofol consumption
21 secondary outcomes
number of oocytes retrieved
Time frame: up to 3 weeks after starting ovarian stimulation treatment
percentage of mature oocytes
Time frame: up to 3 weeks after starting ovarian stimulation treatment
fertilization rate
Time frame: up to 3 weeks after starting ovarian stimulation treatment
embryo quality
Time frame: up to 4 weeks after starting ovarian stimulation treatment
positive pregnancy test
Time frame: up to 3 weeks after transvaginal oocyte retrieval
clinical pregnancy
Time frame: up to 12 weeks after starting ovarian stimulation treatment
Live birth
Time frame: up to 24 weeks after starting ovarian stimulation treatment
BIS score
Time frame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
Observer's Assessment of Alertness/Sedation scale - OAA/S scale
Time frame: assessed every 5 minutes during transvaginal oocyte retrieval procedure
airway obstruction
Time frame: during the procedure
need to ventilate by mask
Time frame: during the procedure
presence of muscle rigidity
Time frame: during the procedure
presence of bradycardia (heart rate less than 50 bpm)
Time frame: during the procedure
hypotension (mean arterial pressure lower than 65 mmHg) for more than 1' during procedure
Time frame: during the procedure
dexmedetomidine consumption
Time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
remifentanil consumption
Time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
vasoactive drug consumption
Time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure
patient satisfaction score
Time frame: end of procedure
physician satisfaction score
Time frame: end of procedure
presence of nausea or vomitus
Time frame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
Post Hospital Discharge Score
Time frame: from end of procedure to discharge from hospital, approximately 4 hours after procedure
Results and safety
The study was stopped early (reason given: Primary investigator transferred in another hospital; ongoing pandemic;). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Attikon Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Primary investigator transferred in another hospital; ongoing pandemic;). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
propofol consumption (time frame: from the beginning to the end of the transvaginal oocyte retrieval procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.