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Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05680363). StuddyBuddy aggregates publicly available trial information.