Infertility
Conditions
Keywords
Reproductive Medicine, Fertilization in Vitro, Oocyte retrieval, Local anaesthesia, Aspiration needle
Brief 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 (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.
Interventions
DEVICESwemed Follicle Aspiration Set Reduced Single Lumen
Thin tip to penetrate the tissue
DEVICESwemed Follicle Aspiration Set Single Lumen (1.4 mm)
Standard (1.4 mm) needle to penetrate the tissue
Sponsors
Vitrolife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* The patient has previously participated in Vitrolife-needle-01 study * The patient has a body mass index ≥35 * Other contra indicator for oocyte retrieval
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Because of Bleeding | During and directly after oocyte retrieval | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thin Follicle Aspiration Needle Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue | 129 |
| Standard Follicle Aspiration Needle Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue | 128 |
| Total | 257 |
Baseline characteristics
| Characteristic | Total | Thin Follicle Aspiration Needle | Standard Follicle Aspiration Needle |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 257 Participants | 129 Participants | 128 Participants |
| Age, Continuous | 34.3 years STANDARD_DEVIATION 4.4 | 34.2 years STANDARD_DEVIATION 4.7 | 34.4 years STANDARD_DEVIATION 4.2 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment Sweden | 257 Participants | 129 Participants | 128 Participants |
| Sex: Female, Male Female | 257 Participants | 129 Participants | 128 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 129 | 0 / 128 |
| serious Total, serious adverse events | 0 / 129 | 0 / 128 |
Outcome results
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).
Time frame: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thin Follicle Aspiration Needle | Visual Analogue Scale | 21.0 0-100 mm | Standard Deviation 17.5 |
| Standard Follicle Aspiration Needle | Visual Analogue Scale | 26.0 0-100 mm | Standard Deviation 19.9 |
Comparison: The primary end-point was the 'overall pain experience', evaluated as described previously. Assuming the mean overall pain in the RN group to be 27 mm (value chosen after analysis of data from a previous study, Cerne et al., 2006) on VAS, with a standard deviation (SD) of 21.5 mm, 121 patients in each group would be needed to demonstrate a decrease in overall pain of 8 mm (30%) with 80% power and a significance level of 0.05 (two-tailed tests).p-value: 0.04Wilcoxon (Mann-Whitney)
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.
Time frame: During and directly after oocyte retrieval
Population: Bleeding during follicle aspiration was graded in all patients included in the study.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thin Follicle Aspiration Needle | Intervention Because of Bleeding | Less than normal bleeding | 40 Participants |
| Thin Follicle Aspiration Needle | Intervention Because of Bleeding | Normal bleeding | 80 Participants |
| Thin Follicle Aspiration Needle | Intervention Because of Bleeding | Bleeding more than normal | 6 Participants |
| Standard Follicle Aspiration Needle | Intervention Because of Bleeding | Less than normal bleeding | 24 Participants |
| Standard Follicle Aspiration Needle | Intervention Because of Bleeding | Normal bleeding | 93 Participants |
| Standard Follicle Aspiration Needle | Intervention Because of Bleeding | Bleeding more than normal | 7 Participants |