Randomized Clinical Trial on Follicular Flushing in IVF
NCT ID: NCT02365350
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2015-01-31
2016-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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STEINER-TAN Needle®
All visible follicles regardless of size in both ovaries will be aspirated and flushed three times by the STEINER-TAN Needle.
STEINER-TAN Needle®
A purpose built new double lumen needle with little dead space.
17G single lumen needle
In the control group all visible follicles regardless of size in both ovaries will be aspirated by the 17G single lumen needle.
17 G single lumen needle
A conventional single lumen IVF aspiration needle.
Interventions
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STEINER-TAN Needle®
A purpose built new double lumen needle with little dead space.
17 G single lumen needle
A conventional single lumen IVF aspiration needle.
Eligibility Criteria
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Inclusion Criteria
* ≤ 5 follicles \>10 mm at the end of the follicular phase as assessed by transvaginal ultrasound
* Presence of two ovaries
* Willingness to participate
* Informed consent
Exclusion Criteria
* Ovaries cannot be reached (e.g. heterotopic ovaries)
* Age \<18 or \>45
18 Years
45 Years
FEMALE
No
Sponsors
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University of Luebeck
OTHER
Responsible Party
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Prof. Dr. med. M.Sc. Georg Griesinger
Prof. Dr. med. M.Sc. Georg Griesinger
Principal Investigators
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Georg Griesinger, MD MSc PhD
Role: PRINCIPAL_INVESTIGATOR
University of Luebeck
Locations
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Universitäres Kinderwunschzentrum Lübeck
Lübeck, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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14-244
Identifier Type: -
Identifier Source: org_study_id