NCT02365350

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

February 6, 2015

Last Update Submit

November 17, 2016

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Mean number of COSs per patient randomized.

    1 day

Secondary Outcomes (5)

  • Mean number of mature metaphase II oocytes

    1 day

  • Pregnancy rate

    7 weeks

  • Mean number of fertilized (2PN) oocytes

    2 days

  • Mean DASS 21 score after the procedure

    1 day

  • Mean duration of the procedure.

    1 day

Study Arms (2)

STEINER-TAN Needle®

EXPERIMENTAL

All visible follicles regardless of size in both ovaries will be aspirated and flushed three times by the STEINER-TAN Needle.

Procedure: STEINER-TAN Needle®

17G single lumen needle

ACTIVE COMPARATOR

In the control group all visible follicles regardless of size in both ovaries will be aspirated by the 17G single lumen needle.

Procedure: 17 G single lumen needle

Interventions

STEINER-TAN Needle®PROCEDURE

A purpose built new double lumen needle with little dead space.

STEINER-TAN Needle®
17 G single lumen needlePROCEDURE

A conventional single lumen IVF aspiration needle.

17G single lumen needle

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female subjects undergoing IVF or ICSI treatment with or without ovarian stimulation
  • ≤ 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

You may not qualify if:

  • BMI \<18 or \>35 kg/m2
  • Ovaries cannot be reached (e.g. heterotopic ovaries)
  • Age \<18 or \>45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäres Kinderwunschzentrum Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Georg Griesinger, MD MSc PhD

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. M.Sc. Georg Griesinger

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 18, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

DE(1)