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

NCT03240302 | Unknown DMC

• 1 other identifier: HYMC-0069-17
• 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 PICSI 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 PICSI 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 using a standard ICSI petri dish.

Device: ICSI petri dish

PICSI Procedure

ACTIVE COMPARATOR

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.

Device: PICSI petri dish

Interventions

ICSI petri dish DEVICE

Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.

ICSI Procedure

PICSI petri dish DEVICE

Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.

PICSI 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 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

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)