Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
NCT ID: NCT05680363
Last Updated: 2026-01-08
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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COMPLETED
NA
41 participants
INTERVENTIONAL
2023-05-01
2025-12-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Standard Sperm Preparation
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Standard Sperm Preparation
Standard sperm preparation
HyperSperm
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
HyperSperm
Multi-step sperm preparation
Interventions
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HyperSperm
Multi-step sperm preparation
Standard Sperm Preparation
Standard sperm preparation
Eligibility Criteria
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Inclusion Criteria
* Treatment planned for embryo transfer at the blastocyst stage
* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm motility (TOTAL) ≥ 40% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram
* Sperm count after swim up ≥ 5x10\^6
* Treatment planned for embryo transfer at the blastocyst stage
* Age: 20-55 years
* Fresh sample (not cryopreserved )
* Sperm concentration ≥ 10x10\^6 /ml in spermogram
* Sperm motility (TOTAL) ≥ 20% in spermogram
* Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram
* Treatment planned for embryo transfer at the blastocyst stage
Exclusion Criteria
* Diabetes or other metabolic disorders.
* Recurrent pregnancy loss (defined as \>2 clinical pregnancies without live birth).
* Previous failures in two or more IVF cycles
Male:
* Any diagnosed sexually transmitted infection (STI)
* Total failure of in vitro fertilization in previous cycles.
20 Years
41 Years
ALL
No
Sponsors
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Fecundis S.A.
OTHER
Responsible Party
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Principal Investigators
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Mariano Buffone, PhD
Role: PRINCIPAL_INVESTIGATOR
Fecundis Lab SL
Locations
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In Vitro Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina
Pregna
Buenos Aires, Buenos Aires F.D., Argentina
WeFIV
Buenos Aires, Buenos Aires F.D., Argentina
Fertya
Rosario, Santa Fe Province, Argentina
Countries
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Other Identifiers
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Fecundis_2
Identifier Type: -
Identifier Source: org_study_id
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