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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05680363

Enrollment

Registered

2023-01-11

Start date

2023-05-01

Completion date

2025-12-18

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

DEVICEHyperSperm

Multi-step sperm preparation

DEVICEStandard Sperm Preparation

Standard sperm preparation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 41 Years

Healthy volunteers

Inclusion criteria

Female: 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 Male: 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

Design outcomes

Primary

Measure	Time frame	Description
Development rate to blastocysts	Days 5-6 post insemination	Total blastocysts / total fertilized oocytes

Secondary

Measure	Time frame	Description
Fertilization rate	Day 1 post insemination	Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes

Countries

Argentina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026