Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2000 participants
INTERVENTIONAL
2013-11-06
2027-12-31
Brief Summary
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Detailed Description
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This density gradient is also used for standard semen preparation for intrauterine insemination. X-bearing spermatozoa and Y-bearing spermatozoa will be identified from the density gradient fractions. Sperm suspensions will be smeared on slides for FISH analysis using centromeric probes for chromosomes 18, X, and Y. The ratio of X- to Y- chromosome bearing spermatozoa will be assessed as a percentage on at least 200 cells per slide. Aneuploid cells and those without signals will be omitted. Unselected fractions of each sample will serve as controls. The rate of X-bearing spermatozoa after 4-layer density gradient will be calculated. After thorough counseling, the selected preconception gender specimen will then be utilized for assisted reproductive fertilization- in vitro fertilization with or without intracytoplasmic sperm injection (ICSI) or intra uterine insemination which are routine standard of care procedures.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sperm sorting
Selection of gender specific spermatozoa using a multilayer density gradient
Sperm Sorting
Selection of gender specific spermatozoa using a multilayer density gradient solution
Interventions
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Sperm Sorting
Selection of gender specific spermatozoa using a multilayer density gradient solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
89 Years
ALL
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Gianpiero Palermo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Center for Reproductive Medicine- Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Cheung S, Elias R, Xie P, Rosenwaks Z, Palermo GD. A non-randomized clinical trial to determine the safety and efficacy of a novel sperm sex selection technique. PLoS One. 2023 Mar 22;18(3):e0282216. doi: 10.1371/journal.pone.0282216. eCollection 2023.
Other Identifiers
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1306014043
Identifier Type: -
Identifier Source: org_study_id
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