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A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method

A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03240302
Enrollment
50
Registered
2017-08-07
Start date
2017-09-30
Completion date
2020-09-30
Last updated
2017-08-07

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

Conditions

Infertility

Brief summary

The aim of this research is to compare sibling oocytes using two sperm selection methods for choosing the best quality spermatozoa before they are injected into oocytes and the influence of each of these methods on embryo quality and IVF outcome.

Interventions

DEVICEICSI petri dish

Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.

DEVICEPICSI petri dish

Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Males aged 18-60 * Females aged 18-35 * Males with mild OTA (oligo terato astheno zoospermia) and at least one failed IVF cycle * Males with normozoospermia with at least 2 unexplained failed IVF cycles * Females with normal FSH and normal AMH values * Females who have retrieved in previous cycles at least 6 oocytes

Exclusion criteria

* Couples who have been exposed to heavy smoking, drugs and chronic diseases * Males who have undergone testicular surgery (TESE) or defined as severe OTA * Females with egg factor infertility

Design outcomes

Primary

MeasureTime frameDescription
Comparison of fertilization rateThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The fertilization rates of the ICSI and PICSI methods will be compared.
Comparison of embryo qualityThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The embryo quality of the ICSI and PICSI methods will be compared.

Secondary

MeasureTime frameDescription
Implantation rateThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and PICSI methods will be compared.
Pregnancy rateThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and PICSI methods will be compared.
Miscarriage rateThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and PICSI methods will be compared.
Live birth rateThree yearsInjected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and PICSI methods will be compared.

Countries

Israel

Contacts

Primary ContactMedeia Michaeli, PhD
medeia.michaeli@gmail.com972-50-6246885

Outcome results

None listed

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