Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
1 other identifier
interventional
41
1 country
4
Brief Summary
Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2025
CompletedJanuary 8, 2026
January 1, 2026
2.6 years
December 6, 2022
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Development rate to blastocysts
Total blastocysts / total fertilized oocytes
Days 5-6 post insemination
Secondary Outcomes (1)
Fertilization rate
Day 1 post insemination
Study Arms (2)
Standard Sperm Preparation
ACTIVE COMPARATORSperm samples in the control group will undergo traditional processing in the lab prior to insemination.
HyperSperm
EXPERIMENTALSperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Interventions
Eligibility Criteria
You may qualify if:
- With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
- Treatment planned for embryo transfer at the blastocyst stage
You may not qualify if:
- Any diagnosed sexually transmitted infection (STI)
- 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:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fecundis S.A.lead
Study Sites (4)
In Vitro Buenos Aires
Buenos Aires, Buenos Aires F.D., 1058, Argentina
Pregna
Buenos Aires, Buenos Aires F.D., 1425, Argentina
WeFIV
Buenos Aires, Buenos Aires F.D., 1428, Argentina
Fertya
Rosario, Santa Fe Province, 2282, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Buffone, PhD
Fecundis Lab SL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2022
First Posted
January 11, 2023
Study Start
May 1, 2023
Primary Completion
December 18, 2025
Study Completion
December 18, 2025
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share