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NCT05680363
Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients
Conditions: Infertility
Sex: All
Ages: 20 Years – 39 Years
Phase: NA
Enrollment: 40
Sponsor: Fecundis S.A.
Location: Argentina
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.
Eligibility Criteria
Female:Inclusion Criteria:With ovarian reserve of between 10 and 20 antral follicles counting both ovariesTreatment planned for embryo transfer at the blastocyst stageExclusion Criteria:Endometrioma or other uterine pathologies.Any alterations of the uterine cavityAny 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 cyclesGynecological history of pelvic surgery (previous diagnostic or non-surgical laparoscopy is allowed).Abnormal vaginal bleeding, not diagnosed at the time of examination.Polycystic ovary syndrome (PCOS)EndometriosisMale:Inclusion Criteria:Age: 20-50 yearsFresh sample (not cryopreserved )Sperm motility (TOTAL) ≥ 40% in spermogramNormal sperm morphology (Kruger criteria) ≥ 6% in spermogramTUNEL: <20% positive sperm in spermogramSperm count after swim up ≥ 5x10^6Treatment planned for embryo transfer at the blastocyst stageExclusion Criteria:Any diagnosed sexually transmitted infection (STI)Total failure of in vitro fertilization in previous cycles.
Source: ClinicalTrials.gov (NCT05680363). StuddyBuddy aggregates publicly available trial information.