InfertilityNCT00924885
Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
A study testing Swemed Follicle Aspiration Set Reduced Single Lumen and Swemed Follicle Aspiration Set Single Lumen (1.4 mm) in people with Infertility, run by Vitrolife at 4 sites in Sweden.
Trial summary
The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Swemed Follicle Aspiration Set Reduced Single Lumen and Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 257 participants
- Where
- 4 sitesSweden
- Study dates
- Jun 2009to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patient has signed an informed consent form before the oocyte retrieval
- The patient is undergoing oocyte retrieval with local anaesthesia
- The patient can speak and understand Swedish
Who cannot join
- The patient has previously participated in Vitrolife-needle-01 study
- The patient has a body mass index ≥35
- Other contra indicator for oocyte retrieval
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
IVF-kliniken Falun
Falun, 79182
Fertilitetscentrum Göteborg
Gothenburg, 40229
Reproduktionmedicinskt Center, Universitetssjukhuset MAS
Malmö, 205 02
Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge
Stockholm, 141 86
About this study
The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.
Read the detailed description
Although the patient is sedated and local analgesia has been given, transvaginal oocytes retrieval with ultrasound guidance can still cause a lot of pain, both during and after the procedure. To reduce the pain, some clinics prefer to use needles as thin as 0.8 mm (outer diameter, OD). A disadvantage with these needles is the increased aspiration time. Therefore a new needle has been developed that has the possibility to reduce pain without a large increase in aspiration time. The needle has a 50 mm long tip with an outer diameter of 0.9 mm. The remaining part of the needle is 300 mm long with an outer diameter of 1.4 mm.
- Conditions
- Infertility
- Being tested
- Swemed Follicle Aspiration Set Reduced Single Lumen, Swemed Follicle Aspiration Set Single Lumen (1.4 mm)
- Keywords
- Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swemed Follicle Aspiration Set Reduced Single LumenDevice
Thin tip to penetrate the tissue
Swemed Follicle Aspiration Set Single Lumen (1.4 mm)Device
Standard (1.4 mm) needle to penetrate the tissue
| Study group | Role | What they receive |
|---|---|---|
| Thin Follicle Aspiration Needle | Experimental | Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg. Receives: Device: Swemed Follicle Aspiration Set Reduced Single Lumen |
| Standard Follicle Aspiration Needle | Active comparator | Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle.
The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg. Receives: Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Rating of pain was performed by self-assessment by means of Visual Analogue Scale (VAS) consisting of a line oriented vertically on a paper with a range from 0 mm (no pain) to 100 mm (unbearable pain).
Measured: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
Secondary outcomes (1)
Intervention Because of Bleeding
Vaginal bleeding during or after the procedure was graded subjectively by the physician as (i) less than normal, (ii) normal or (iii) more than normal.
Measured: During and directly after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Torbjörn Hillensjö, MD PhD, Principal investigator, Fertility Center Scandinavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924885
- Sponsor's protocol ID
- Vitrolife-needle-01
- Status last verified
- Jan 2021
- First submitted
- 17 Jun 2009
- Last updated
- 26 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wikland M, Blad S, Bungum L, Hillensjo T, Karlstrom PO, Nilsson S. A randomized controlled study comparing pain experience between a newly designed needle with a thin tip and a standard needle for oocyte aspiration. Hum Reprod. 2011 Jun;26(6):1377-83. doi: 10.1093/humrep/der100. Epub 2011 Apr 5.
PubMed 21467200
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
- ClinicalTrials.gov ID
- NCT00924885
- Acronym / sponsor ID
- Vitrolife-needle-01
- Conditions
- Infertility
- Keywords
- Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the pain experience between the patients that have had their transvaginal oocytes retrieval with ultrasound guidance performed with reduced single lumen needle (Vitrolife Sweden AB, Gothenburg) with the patients that have had follicle aspiration needle, 1.4 outer diameter (Vitrolife Sweden AB, Gothenburg), during the procedure.
Detailed description
Although the patient is sedated and local analgesia has been given, transvaginal oocytes retrieval with ultrasound guidance can still cause a lot of pain, both during and after the procedure. To reduce the pain, some clinics prefer to use needles as thin as 0.8 mm (outer diameter, OD). A disadvantage with these needles is the increased aspiration time. Therefore a new needle has been developed that has the possibility to reduce pain without a large increase in aspiration time. The needle has a 50 mm long tip with an outer diameter of 0.9 mm. The remaining part of the needle is 300 mm long with an outer diameter of 1.4 mm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thin Follicle Aspiration Needle | Experimental | Device: Swemed Follicle Aspiration Set Reduced Single LumenTransvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the RN needle that had an outer diameter of 0.9 mm (20 gauge) and inner diameter of 0.6 mm for the last 50 mm from the tip of the needle and an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg. |
| Standard Follicle Aspiration Needle | Active comparator | Device: Swemed Follicle Aspiration Set Single Lumen (1.4 mm)Transvaginal oocyte retrieval was performed under local anaesthesia and under guidance of ultrasound with the SN needle that had an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the remaining length of the needle. or the SN with an outer diameter of 1.4 mm (17 gauge) and inner diameter of 1 mm for the whole length of the needle. The puncture procedure was performed according to each clinic's standard routine. Aspiration pressure was kept at a negative pressure between 90 and 120 mmHg. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The patient has signed an informed consent form before the oocyte retrieval
- The patient is undergoing oocyte retrieval with local anaesthesia
- The patient can speak and understand Swedish
Key exclusion criteria (3 listed)
- The patient has previously participated in Vitrolife-needle-01 study
- The patient has a body mass index ≥35
- Other contra indicator for oocyte retrieval
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 |
|---|---|---|
| Swemed Follicle Aspiration Set Reduced Single LumenThin tip to penetrate the tissue | Device | Thin Follicle Aspiration Needle |
| Swemed Follicle Aspiration Set Single Lumen (1.4 mm)Standard (1.4 mm) needle to penetrate the tissue | Device | Standard Follicle Aspiration Needle |
Primary outcome
Visual Analogue Scale
Time frame: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
Rating of pain was performed by self-assessment by means of Visual Analogue Scale (VAS) consisting of a line oriented vertically on a paper with a range from 0 mm (no pain) to 100 mm (unbearable pain).
1 secondary outcome
Intervention Because of Bleeding
Time frame: During and directly after oocyte retrieval
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21467200Wikland M, Blad S, Bungum L, Hillensjo T, Karlstrom PO, Nilsson S. A randomized controlled study comparing pain experience between a newly designed needle with a thin tip and a standard needle for oocyte aspiration. Hum Reprod. 2011 Jun;26(6):1377-83. doi: 10.1093/humrep/der100. Epub 2011 Apr 5.
- Link to the published articleLink provided by the sponsor.
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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.
Torbjörn Hillensjö, MD PhD principal investigator
Fertility Center Scandinavia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swemed Follicle Aspiration Set Reduced Single Lumen and Swemed Follicle Aspiration Set Single Lumen (1.4 mm) in people with Infertility, run by Vitrolife at 4 sites in Sweden.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Analogue Scale (time frame: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924885, which also lists 1 linked publication.
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 26 Jan 2021.