Comparison of two ready-to-use systems specially designed for physiological intracytoplasmic sperm injection (ICSI): PICSI® versus Sperm Slow™, a prospective randomised trial

Comparison of two ready-to-use systems specially designed for sperm-hyaluronic acid (HA) binding selection before intracytoplasmic sperm injection (physiological ICSI): PICSI® versus Sperm Slow™, a prospective randomised trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72668039

Enrollment

100

Registered

2010-10-11

Start date

2010-09-01

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Intracytoplasmic sperm injection (ICSI) Pregnancy and Childbirth Fertility

Interventions

100 ICSI treatments randomly carried out with PICSI® Sperm Selection Device or with Sperm Slow™ for sperm selection. Randomisation process conducted with sealed envelopes, assigning 50 subjects to eac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Infertile women not older than 41 years undergoing ICSI treatment at GynePro Medical Center 2. Semen parameters of the male partner: 2.1. Presence of ejaculate motile spermatozoa with total sperm number greater than or equal to 1,000,000 2.2. Sperm motility greater than or equal to 5%

Exclusion criteria

Exclusion criteria: 1. Women older than 41 years old 2. Patients with male partners with testicular spermatozoa or severe oligoastenoteratozoospermia (total sperm number less than 1,000,000 and sperm motility less than 5%)

Design outcomes

Primary

Measure	Time frame
1. Oocyte fertilisation rate, measured 15 - 22 hours after oocyte insemination 2. Embryo cleavage rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 3. Top-quality embryo rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 4. Pregnancy rate, measured 30 days after the embryo transfer 5. Implantation rate, measured 30 days after the embryo transfer	—

Measure

Time frame

1. Oocyte fertilisation rate, measured 15 - 22 hours after oocyte insemination 2. Embryo cleavage rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 3. Top-quality embryo rate, measured at day of embryo transfer (2, 3 or 5 days after oocyte insemination) 4. Pregnancy rate, measured 30 days after the embryo transfer 5. Implantation rate, measured 30 days after the embryo transfer

—

Secondary

Measure	Time frame
Duration of ICSI procedure, measured at time of oocyte insemination	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 26, 2026