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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Infertility

Treatments: Device: PICSI petri dish; Device: ICSI petri dish

Study type: Interventional

Funder types: Other

Identifiers

NCT03240302

HYMC-0069-17

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

ICSI Procedure

Active Comparator group

Description:

The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.

Treatment:

Device: ICSI petri dish

PICSI Procedure

Active Comparator group

Description:

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.

Treatment:

Device: PICSI petri dish