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

H

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)

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

Trial contacts and locations

1

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Central trial contact

Medeia Michaeli, PhD

Data sourced from clinicaltrials.gov

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