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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swemed Follicle Aspiration Set Reduced Single Lumen | Device | Thin tip to penetrate the tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During and directly after oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Hillensjö, MD PhD | Fertility Center Scandinavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVF-kliniken Falun | Falun | 79182 | Sweden | |||
| Fertilitetscentrum Göteborg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21467200 | Derived | 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. |
| Label | URL |
|---|---|
| Link to the published article | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Thin Follicle Aspiration Needle | Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue |
| FG001 | Standard Follicle Aspiration Needle | Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thin Follicle Aspiration Needle | Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue |
| BG001 | Standard Follicle Aspiration Needle | Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | 0-100 mm | After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes. |
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Records of serious events were collected over a period of one week after oocyte pick-up (OPU)
Definitions same as used by .gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thin Follicle Aspiration Needle | Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of clinical investigations | Vitrolife | 0046708228063 | thardarson@vitrolife.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Swemed Follicle Aspiration Set Single Lumen (1.4 mm) | Device | Standard (1.4 mm) needle to penetrate the tissue |
|
| Gothenburg |
| 40229 |
| Sweden |
| Reproduktionmedicinskt Center, Universitetssjukhuset MAS | Malmö | 205 02 | Sweden |
| Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge | Stockholm | 141 86 | Sweden |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | 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. | Bleeding during follicle aspiration was graded in all patients included in the study. | Posted | Count of Participants | Participants | During and directly after oocyte retrieval |
|
|
|
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | Standard Follicle Aspiration Needle | Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue | 0 | 128 | 0 | 128 |
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| Bleeding more than normal |
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