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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02610114 |
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Date of registration:
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05/11/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Improvement of Cell Selection in Reproductive Techniques
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Scientific title:
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A New Method to Improve the Selection of Zygotes in the Context of Assisted Reproductive Medicine. A Randomized Controlled Blinded Monocenter Study |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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220 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02610114 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Jürgen Weiss, Professor |
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Address:
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Telephone:
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+41 41 205 36 08 |
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Email:
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juergen.weiss@luks.ch |
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Affiliation:
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Name:
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Jürgen Weiss, Professor |
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Address:
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Telephone:
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+41 41 205 36 06 |
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Email:
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juergen.weiss@luks.ch |
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Affiliation:
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Name:
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Jürgen Weiss, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Luzerner Kantonsspital, Neue Frauenklinik |
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Key inclusion & exclusion criteria
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Inclusion criteria (for both male and female, couples):
- 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
Exclusion criteria (for female):
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Infertility
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Intervention(s)
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Other: Z-Score
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Other: Z-Score and computer algorithm
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Primary Outcome(s)
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Clinical pregnancy
[Time Frame: min. 4 weeks after embryo transfer]
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Secondary Outcome(s)
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Life Birth
[Time Frame: through study completion, an average of 40 weeks after last menstrual period]
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Ongoing clinical pregnancy
[Time Frame: min. 9 weeks after embryo transfer]
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Secondary ID(s)
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REPROLUKS 002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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