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Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Primary Purpose

Sperm DNA Fragmentation, Infertility

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PICSI
MACS
Sponsored by
Ganin Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sperm DNA Fragmentation focused on measuring Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Case must have PGT-A for all of her blastocysts
  • Males diagnosed with abnormal sperm DNA fragmentation index (> 20%).
  • Normo responder (> 5 mature oocytes)
  • Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI

Exclusion Criteria:

  • Leukocytospermia
  • Presence of varicocele.
  • Known genetic abnormality
  • Use of sperm or oocyte donors
  • Use of gestational carrier
  • Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection
  • Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Sites / Locations

  • Ganin Fertility CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PICSI

MACS

Arm Description

Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Individual bound sperm selection is done followed y ICSI

Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for ICSI.

Outcomes

Primary Outcome Measures

Euploidy rate
Defined as the proportion of euploid blastocysts
Aneuploidy rate
Defined as the proportion of aneuploid blastocysts
Low mosaic rate
Defined as the proportion of low mosaic blastocysts
High mosaic rate
Defined as the proportion of high mosaic blastocysts

Secondary Outcome Measures

Fertilization rate
Defined as the proportion of fertilizaed oocytes
Cleavage rate
Defined as the proportion of cleaved embryos on day 3
Blastocyst development rate
Defined as the proportion of blastocysts formed on day 5 or 6
Blastocyst quality rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

Full Information

First Posted
August 6, 2022
Last Updated
January 10, 2023
Sponsor
Ganin Fertility Center
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1. Study Identification

Unique Protocol Identification Number
NCT05494216
Brief Title
Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
Official Title
Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ganin Fertility Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparing different advanced sperm selection techniques like Physiological ICSI (PICSI) and magnetic activated cell sorting (MACS) in terms of the PGT-A outcomes of each arm blastocysts
Detailed Description
Advanced sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with lower Sperm DNA fragmentation. Previous studies compared the pre-implantation embryo development parameters of those techniques, but none looked at comparing the PGT-A results or euploidy rates of the blastocysts derived from each sperm selection. PGT-A cases will be randomized on the day of ICSI to the 2 assigned sperm selection techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sperm DNA Fragmentation, Infertility
Keywords
Sperm selection, PICSI, MACS, Sperm DNA fragmentation, PGT-A, Euploidy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PICSI
Arm Type
Active Comparator
Arm Description
Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Individual bound sperm selection is done followed y ICSI
Arm Title
MACS
Arm Type
Active Comparator
Arm Description
Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for ICSI.
Intervention Type
Other
Intervention Name(s)
PICSI
Intervention Description
Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
Intervention Type
Other
Intervention Name(s)
MACS
Intervention Description
Sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Primary Outcome Measure Information:
Title
Euploidy rate
Description
Defined as the proportion of euploid blastocysts
Time Frame
15 days post ICSI
Title
Aneuploidy rate
Description
Defined as the proportion of aneuploid blastocysts
Time Frame
15 days post ICSI
Title
Low mosaic rate
Description
Defined as the proportion of low mosaic blastocysts
Time Frame
15 days post ICSI
Title
High mosaic rate
Description
Defined as the proportion of high mosaic blastocysts
Time Frame
15 days post ICSI
Secondary Outcome Measure Information:
Title
Fertilization rate
Description
Defined as the proportion of fertilizaed oocytes
Time Frame
1 day
Title
Cleavage rate
Description
Defined as the proportion of cleaved embryos on day 3
Time Frame
3 days
Title
Blastocyst development rate
Description
Defined as the proportion of blastocysts formed on day 5 or 6
Time Frame
5-6 days
Title
Blastocyst quality rate
Description
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor
Time Frame
5-6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Case must have PGT-A for all of her blastocysts Males diagnosed with abnormal sperm DNA fragmentation index (> 20%). Normo responder (> 5 mature oocytes) Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of ICSI Exclusion Criteria: Leukocytospermia Presence of varicocele. Known genetic abnormality Use of sperm or oocyte donors Use of gestational carrier Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eman Hasanen, BSc.
Phone
01282012291
Email
em.saber@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Hasanen, BSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manar Hozayen, MSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amr Elshimy, BSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanaa Alkhader, MBBS/MD
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hosam Zaki, MSc, FRCOG
Organizational Affiliation
Ganin Fertility Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yara Hazem, BP
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ganin Fertility Center
City
Cairo
State/Province
Maadi
ZIP/Postal Code
11728
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eman Hasanen
Phone
01282012291
Email
em.saberh@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

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