NCT05680363CompletedNot Applicable
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Fecundis S.A.4 sites in 1 country41 target enrollmentStarted: May 1, 2023Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 4
- Primary Endpoint
- Development rate to blastocysts
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 41 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
- •Treatment planned for embryo transfer at the blastocyst stage
Exclusion Criteria
- •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
- •Inclusion Criteria for IVF:
- •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
- •Inclusion Criteria for ICSI:
- •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:
- •Any diagnosed sexually transmitted infection (STI)
- •Total failure of in vitro fertilization in previous cycles.
Arms & Interventions
Standard Sperm Preparation
Active Comparator
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Intervention: Standard Sperm Preparation (Device)
HyperSperm
Experimental
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Intervention: HyperSperm (Device)
Outcomes
Primary Outcomes
Development rate to blastocysts
Time Frame: Days 5-6 post insemination
Total blastocysts / total fertilized oocytes
Secondary Outcomes
- Fertilization rate(Day 1 post insemination)
Investigators
Study Sites (4)
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