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)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Hillel Yaffe Medical Center
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Comparison of fertilization rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ICSI Procedure
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.
Intervention: ICSI petri dish (Device)
PICSI Procedure
The PICSI procedure is based on a selection of mature spermatozoa with CD44 receptors and their injection into the oocyte using the PICSI petri dish that has been coated with hyaluronic acid on its bottom.
Intervention: PICSI petri dish (Device)
Outcomes
Primary Outcomes
Comparison of fertilization rate
Time Frame: Three years
Injected 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 quality
Time Frame: Three years
Injected 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 Outcomes
- Live birth rate(Three years)
- Implantation rate(Three years)
- Pregnancy rate(Three years)
- Miscarriage rate(Three years)