NCT02610114

Brief Summary

It is the aim of this trial to use a new computerized cell selection method, in addition to the current and world-wide used scoring system of fertilized oocytes implemented by Scott, to determine whether this leads to an increase in pregnancy rates in women undergoing assisted reproductive techniques.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 5, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

November 5, 2015

Last Update Submit

March 20, 2017

Conditions

Infertility

Keywords

Assisted reproductive technology (ART)zygotesZ-score (Zygote Score)Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    Clinical pregnancy is defined as a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It includes ectopic pregnancy.

    min. 4 weeks after embryo transfer

Secondary Outcomes (2)

  • Ongoing clinical pregnancy

    min. 9 weeks after embryo transfer

  • Life Birth

    through study completion, an average of 40 weeks after last menstrual period

Study Arms (2)

Z-Score and computer algorithm

EXPERIMENTAL
Other: Z-Score and computer algorithm

Z-Score

ACTIVE COMPARATOR
Other: Z-Score

Interventions

Z-Score and computer algorithmOTHER

In addition to the routine Z-score for zygote selection, if needed, the photographs of the zygotes already taken for quality and safety reasons are analysed using the new computer algorithm. Within a few minutes it generates a score, determining the quality of the cells. The two best cells upon Z-score result and new computer algorithm result are selected for first transfer.

Z-Score and computer algorithm
Z-ScoreOTHER

After fertilisation pronuclei and nucleoli can be seen inside the cells by microscope. Routinely, the alignment of nucleoli can be used generating a score, the Z-score 1-4, established by Scott. Two zygotes getting the best Z-score are selected for cell culture and the cells that develop to embryo stage are used for first transfer.

Z-Score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Woman with age 18 years or older
  • Man with age 18 years or older
  • Couples who could gain fertilized cells after In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI) after hormonal stimulation due to sterility treatments
  • Couples presenting negative blood samples of human immunodeficiency virus (HIV) and Hepatitis B/C
  • Signed routine contracts between hospital and patient wanting assisted reproductive technology (ART)
  • Signed informed study consent
  • Expectation of life more than 18 years
  • No medical contraindication to become pregnant (female)
  • Routine criteria for assisted reproductive techniques

You may not qualify if:

  • Poor health status acc. to Investigator's judgement
  • Expectation of life below 18 years
  • Risk of ovarian hyperstimulation syndrome
  • Avital cells (cells that do not further develop or die)
  • Treatment due to fertility preservation, e.g. in case of cancer
  • Problems after stimulation and follicle puncture
  • Endometrial pathologies like polyps, submucous fibroids, etc.
  • Any preceding stimulation cycle with endometrial thickness below 6mm
  • Less than 4 fertilized oocytes
  • Patient (and partner) wishes single embryo Transfer
  • Failure to become pregnant with new zygote selection method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neue Frauenklinik

Lucerne, 6000 Luzern 16, Switzerland

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Jürgen Weiss, Professor

    Luzerner Kantonsspital, Neue Frauenklinik

    STUDY CHAIR

Central Study Contacts

Jürgen Weiss, Professor

CONTACT

+41 41 205 36 06juergen.weiss@luks.ch

Roger Getzmann

CONTACT

+41 41 205 28 40roger.getzmann@luks.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 20, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2018

Study Completion

November 1, 2018

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

CH(1)