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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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11 April 2016 |
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Main ID: |
NCT02235103 |
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Date of registration:
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05/09/2014 |
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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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The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate.
DNAFRAG |
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Scientific title:
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The Predictive Value of the Sperm Chromatin Dispersion Test, Halosperm®, Before and After Sperm Preparation for Clinical Pregnancy in Cases of Unexplained Infertility Treated With Intra-uterine Insemination (First Cycle) and Ovulation Induction With Clomiphene Citrate. |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02235103 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Frank Vandekerckhove, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fertility Centre, University Hospital Ghent |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Unexplained infertility, i.e. female patients with ovulatory cycles and patent tubes;
normal sperm analysis (WHO criteria).
- Patient agrees to have a first treatment cycle with intra-uterine insemination and
ovulation-induction with clomiphene citrate.
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Unexplained Infertility
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Intervention(s)
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Other: Sperm Chromatin Dispersion Test
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Primary Outcome(s)
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Clinical pregnancy rate
[Time Frame: 2 1/2 weeks after insemination]
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Secondary Outcome(s)
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Ongoing pregnancy rate
[Time Frame: 20 weeks after insemination]
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Live birth rate
[Time Frame: 42 weeks after insemination]
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Secondary ID(s)
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B670201316616
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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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