Randomized Clinical Trial on Follicular Flushing in IVF
Condition: Infertility
MeSH terms: Infertility; Flushing
Study type: Interventional

Summary: 
      The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN
      Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.
    

Detailed description: 
      Rationale:

      Since the number of oocytes available for IVF is a determinant of the cumulative chance of a
      patient to achieve pregnancy, it is of paramount importance to optimize the number of oocytes
      at oocyte pick-up. This especially for a fraction of patients, who despite high-dosed FSH
      stimulation, produce only a small number of growing follicles (poor response).

      Objective:

      The primary objective is to demonstrate superiority of follicle flushing with the STEINER-TAN
      Needle® as compared to single lumen aspiration in terms of numbers of COCs retrieved.

      The secondary objective is to study differences in numbers of mature oocytes, proportion of
      patients undergoing embryo transfer, pregnancy rate, duration of the procedure, impact on
      patient burden (as assessed by the DASS 21, the German pain questionnaire [www.dgss.org]) and
      subjective patient experience.

      Study design:

      Prospective, single-center, randomized controlled, open trial comparing a 17G single lumen
      aspiration needle with a modified double lumen needle system (STEINER-TAN Needle®) for
      follicular flushing during oocyte pick-up in IVF patients with poor ovarian response.

      Study population:

      Patients with a BMI < 35 kg/m2 and an indication for IVF or ICSI with or without ovarian
      stimulation presenting with ≤ 5 follicles >10mm in the ovaries at the end of the follicular
      phase of the treatment cycle will be eligible for inclusion. Final oocyte maturation is to be
      induced by hCG administration as soon as the leading follicle reaches a mean diameter of 18mm
      or the day thereafter.

      Intervention:

      Eighty (n=80) patients will be randomly allocated on the day when the decision is taken to
      administer hCG to one of the following two procedures. In the study group all visible
      follicles regardless of size in both ovaries will be first aspirated and then flushed at
      least three times by the STEINER-TAN Needle® system. In the control group all visible
      follicles regardless of size in both ovaries will be aspirated by the 17G single lumen
      needle.

      Main study parameters/endpoints:

      The main study parameter/endpoint is the mean number of COSs per patient randomized.

      Secondary endpoints are the mean number of mature metaphase II oocytes per patient and per
      COC retrieved per patient, the number of fertilized (2PN) oocytes, the fertilization rate
      (number of 2PN oocytes/number of injected or inseminates oocytes), the pregnancy rate (viable
      pregnancy at 6-7 gestational weeks/randomized patient), the mean DASS 21 score after the
      procedure, the mean duration of the procedure (min, sec), the COC retrieval rate per puncture
      follicle and the proportion of randomized patients not reaching embryo transfer. Furthermore,
      the patients will be interviewed about their overall experience of the procedure.
    

Intervention name(s): STEINER-TAN Needle®; 17 G single lumen needle
Intervention type(s): Procedure; Procedure
Intervention description(s): A purpose built new double lumen needle with little dead space.; A conventional single lumen IVF aspiration needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment