Trial Outcomes & Findings for Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles (NCT NCT00924885)

Last Updated: 2021-01-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

257 participants

Primary outcome timeframe

After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.

Results posted on

2021-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Thin Follicle Aspiration Needle Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue	Standard Follicle Aspiration Needle Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
Overall Study STARTED	129	128
Overall Study COMPLETED	126	124
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thin Follicle Aspiration Needle n=129 Participants Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue	Standard Follicle Aspiration Needle n=128 Participants Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue	Total n=257 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=129 Participants	0 Participants n=128 Participants	0 Participants n=257 Participants
Age, Categorical Between 18 and 65 years	129 Participants n=129 Participants	128 Participants n=128 Participants	257 Participants n=257 Participants
Age, Categorical >=65 years	0 Participants n=129 Participants	0 Participants n=128 Participants	0 Participants n=257 Participants
Age, Continuous	34.2 years STANDARD_DEVIATION 4.7 • n=129 Participants	34.4 years STANDARD_DEVIATION 4.2 • n=128 Participants	34.3 years STANDARD_DEVIATION 4.4 • n=257 Participants
Sex: Female, Male Female	129 Participants n=129 Participants	128 Participants n=128 Participants	257 Participants n=257 Participants
Sex: Female, Male Male	0 Participants n=129 Participants	0 Participants n=128 Participants	0 Participants n=257 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	129 Participants n=129 Participants	128 Participants n=128 Participants	257 Participants n=257 Participants

PRIMARY outcome

Timeframe: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.

Outcome measures

Outcome measures
Measure	Thin Follicle Aspiration Needle n=126 Participants Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue	Standard Follicle Aspiration Needle n=124 Participants Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
Visual Analogue Scale	21.0 0-100 mm Standard Deviation 17.5	26.0 0-100 mm Standard Deviation 19.9

SECONDARY outcome

Timeframe: During and directly after oocyte retrieval

Population: Bleeding during follicle aspiration was graded in all patients included in the study.

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.

Outcome measures

Outcome measures
Measure	Thin Follicle Aspiration Needle n=126 Participants Swemed Follicle Aspiration Set Reduced Single Lumen: Thin tip to penetrate the tissue	Standard Follicle Aspiration Needle n=124 Participants Swemed Follicle Aspiration Set Single Lumen (1.4 mm): Standard (1.4 mm) needle to penetrate the tissue
Intervention Because of Bleeding Less than normal bleeding	40 Participants	24 Participants
Intervention Because of Bleeding Normal bleeding	80 Participants	93 Participants
Intervention Because of Bleeding Bleeding more than normal	6 Participants	7 Participants

Adverse Events

Thin Follicle Aspiration Needle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Follicle Aspiration Needle

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of clinical investigations

Vitrolife

Phone: 0046708228063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place