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

NCT03240276 | Unknown DMC

• 1 other identifier: HYMC-0070-17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Comparison of fertilization rate

  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 IMSI methods will be compared.

  Three years

• Comparison of embryo quality

  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 IMSI methods will be compared.

  Three years

Secondary Outcomes (4)

• Implantation rate

  Three years

• Pregnancy rate

  Three years

• Miscarriage rate

  Three years

• Live birth rate

  Three years

Study Arms (2)

ICSI Procedure

ACTIVE COMPARATOR

The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte

Other: Standard ICSI procedure for sperm injection into oocyte

IMSI Procedure

ACTIVE COMPARATOR

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

Device: MSOME; Other: IMSI Procedure

Interventions

Standard ICSI procedure for sperm injection into oocyte OTHER

The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes

ICSI Procedure

MSOME DEVICE

Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification

Also known as: Motile Sperm Organelle Morphology Examination

IMSI Procedure

IMSI Procedure OTHER

Injection of sperm that has been selected by the MSOME method into oocytes

IMSI Procedure

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Einat Shalom Paz, MD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

• Medeia Michaeli, PhD

  Hillel Yaffe Medical Center

  STUDY DIRECTOR

Central Study Contacts

Medeia Michaeli, PhD

CONTACT

972-50-6246885; medeia.michaeli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 7, 2017
• Study Start: September 1, 2017
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: August 7, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)