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Main
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Note: This record shows only the 20 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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28 January 2013 |
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Main ID: |
NCT01219504 |
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Date of registration:
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08/10/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
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Scientific title:
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Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01219504 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Richard T Scott, 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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Reproductive Medicine Associates of New Jersey |
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Key inclusion & exclusion criteria
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This study will recruit patients from the NY/NJ/CT/eastern PA area only.
Inclusion Criteria:
1. Maximum of one prior failed IVF treatment cycle
2. Female partner less than 35 years of age
3. Normal day 3 FSH level (<10 miu/mL)
4. Total basal antral follicle count greater than or equal to 12
5. Male partner with greater than 100,000 total motile spermatozoa and at least 1%
normal forms
6. Body mass index (BMI) < or = 32
7. Normal uterine cavity
Exclusion Criteria:
1. Diagnosis of chronic anovulation secondary to polycystic ovarian disease
2. Diagnosis of endometrial insufficiency
3. Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with
PGD to rule out a known genetic defect)
4. Use of testicular aspiration or biopsy procedures to obtain sperm
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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1 Embryo Will be Biopsied and 1 Embryo is Not
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Each Patient is Both Case and Control
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Primary Outcome(s)
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Impact of biopsy on delivery
[Time Frame: 1 year]
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Impact of biopsy on pregnancy
[Time Frame: 1 year]
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Secondary ID(s)
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RMA-00-17
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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