Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients

CompletadoClinicalTrials.gov

ID: NCT05680363Tipo: INTERVENTIONALInicio: 1 de may de 2023Fin estimado: 18 de dic de 2025

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 20 YearsEdad máxima: 41 YearsSexo: ALL

Criterios de inclusión

Female:
With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
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

Criterios de exclusión

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:
Any diagnosed sexually transmitted infection (STI)
Total failure of in vitro fertilization in previous cycles.

Intervenciones

device

HyperSperm

Multi-step sperm preparation

device

Standard Sperm Preparation

Standard sperm preparation

Ubicaciones

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

Patrocinadores

PrincipalFecundis S.A.

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