Clinical trial NCT00924885: Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Official title: Experience of Pain During Oocyte Retrieval- a Comparison Between Two Aspiration Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Reproductive Medicine
Fertilization in Vitro
Oocyte retrieval
Local anaesthesia
Aspiration needle
Lead sponsor: Vitrolife
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 257
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: After the oocyte retrieval and before the patient leaves the operation room e.g. within a maximum of 30 minutes.
Secondary outcomes:
measure: Intervention Because of Bleeding
timeFrame: During and directly after oocyte retrieval
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: IVF-kliniken Falun
city: Göteborg
country: Sweden
facility: Fertilitetscentrum Göteborg
city: Malmö
country: Sweden
facility: Reproduktionmedicinskt Center, Universitetssjukhuset MAS
city: Stockholm
country: Sweden
facility: Fertilitetsenheten K59 Karolinska Universitetssjukhuset, Huddinge
Study officials:
affiliation: Fertility Center Scandinavia
name: Torbjörn Hillensjö, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.