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

Hillel Yaffe Medical Center

Status: Unknown

Conditions: Infertility

Treatments: Device: MSOME; Other: IMSI Procedure; Other: Standard ICSI procedure for sperm injection into oocyte

Study type: Interventional

Funder types: Other

Identifiers

NCT03240276

HYMC-0070-17

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 defined as Moderate OTA or Isolated Teratozoospermia with less than 4% morphologically normal spermatozoa
• Patients with 0.5- 7% normal sperm according to MSOME analysis
• Females with normal FSH and AMH values
• Females who have retrieved at least 6 oocytes in previous cycles
• Couples who have had at least 2 failed IVF-ICSI cycles

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

Treatment:

Other: Standard ICSI procedure for sperm injection into oocyte

IMSI Procedure

Active Comparator group

Description:

The IMSI procedure is the injection of normal ultramorphological spermatozoa that have been selected using an inverted microscope with magnification of 6300x (MSOME)

Treatment:

Other: IMSI Procedure

Device: MSOME