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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ICSI petri dish
PICSI petri dish
Sponsored by
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ICSI Procedure

PICSI Procedure

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Implantation rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and PICSI methods will be compared.
Pregnancy rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and PICSI methods will be compared.
Miscarriage rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and PICSI methods will be compared.
Live birth rate
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and PICSI methods will be compared.

Full Information

First Posted
July 31, 2017
Last Updated
August 2, 2017
Sponsor
Hillel Yaffe Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03240302
Brief Title
A Comparative Study of Sibling Oocytes: ICSI vs. the PICSI Sperm Selection Method
Official Title
A Comparative Study of Sibling Oocytes, Which Examines Two Sperm Selection Methods for Top Quality of Spermatozoa , Prior Intracytoplasmic Sperm Injection (ICSI) Performance, and Their Effect on Embryo Quality and IVF Outcome: A Common Selection Method Based on Morphology (ICSI) vs. a Selection Method for Mature Spermatozoa With CD44 Receptors for Hyaluronic Acid (PICSI - Physiological Selected Intracytoplasmic Sperm Injection)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICSI Procedure
Arm Type
Active Comparator
Arm Description
The ICSI procedure is the standard procedure of selection and injection of sperm into the oocyte using a standard ICSI petri dish.
Arm Title
PICSI Procedure
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
ICSI petri dish
Intervention Description
Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.
Intervention Type
Device
Intervention Name(s)
PICSI petri dish
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of fertilization rate
Description
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.
Time Frame
Three years
Title
Comparison of embryo quality
Description
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.
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Implantation rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The implantation rates of the ICSI and PICSI methods will be compared.
Time Frame
Three years
Title
Pregnancy rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The pregnancy rates of the ICSI and PICSI methods will be compared.
Time Frame
Three years
Title
Miscarriage rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The miscarriage rates of the ICSI and PICSI methods will be compared.
Time Frame
Three years
Title
Live birth rate
Description
Injected sibling oocytes are incubated in a time-lapse incubator which enables ongoing observation after fertilization and cleavage of each oocyte. The live birth rates of the ICSI and PICSI methods will be compared.
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Medeia Michaeli, PhD
Phone
972-50-6246885
Email
medeia.michaeli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Shalom Paz, MD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Medeia Michaeli, PhD
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Medeia Michaeli, PhD
Phone
972-50-6246885
Email
medeia.michaeli@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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