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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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8 January 2018 |
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Main ID: |
NCT02166567 |
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Date of registration:
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14/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
Spermsorting |
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Scientific title:
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The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection. |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02166567 |
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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: Triple (Participant, Care Provider, 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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Christian De Geyter, MD, Prof. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Univeristy Hospital Basel |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- infertile couples needing treatment with ICSI
- male infertility as defined by the WHO 2010 criteria
- age of the treated women should be between 22 and 39 years of age.
- normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and
AMH-concentration above 10 pmol/l.
- signed consent form.
Exclusion Criteria:
- normal male infertility, as defined by the WHO 2010 criteria
- age of the treated women below 22 years and above 39 years
- reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced
AMH-concentration.
- Not more than two preceding unsuccessfull treatments with ICSI
- Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric
illness.
- Participation in another study.
- lack of a signed consent form.
Age minimum:
22 Years
Age maximum:
39 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Male Infertility
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Intervention(s)
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Procedure: Swim-up
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Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
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Primary Outcome(s)
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Ongoing pregnancy rate
[Time Frame: Week 12 of gestation]
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Secondary Outcome(s)
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Number of diploidic fertilized oocytes.
[Time Frame: one day after intracytoplasmic sperm injection]
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Secondary ID(s)
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YOPRO
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EKBB178/12
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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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