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OpenTrials
Completed

NCT Number: NCT05680363

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–41 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

In Vitro Buenos Aires, Buenos Aires, Buenos Aires F.D., Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

HyperSperm

Device

Multi-step sperm preparation

Standard sperm preparation

Device

Standard sperm preparation

Primary outcomes

  1. Development rate to blastocysts

    Time frame: Days 5-6 post insemination

    Total blastocysts / total fertilized oocytes

Secondary outcomes

  1. Fertilization rate

    Time frame: Day 1 post insemination

    Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes

Sponsors and collaborators

Lead sponsor

Fecundis S.A.

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 11, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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