Trials Sponsors Conditions Drugs Pricing

Conditions

Infertility Sperm DNA Fragmentation

Keywords

Sperm selectionPICSIMACSSperm DNA fragmentationPGT-AEuploidy rate

Outcome Measures

Primary Outcomes (4)

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

Secondary Outcomes (4)

Fertilization rate
1 day
Cleavage rate
3 days
Blastocyst development rate
5-6 days
Blastocyst quality rate
5-6 days

Study Arms (2)

PICSI

ACTIVE COMPARATOR

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

Other: PICSI

MACS

ACTIVE COMPARATOR

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.

Other: MACS

Interventions

PICSIOther

Sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index

PICSI

MACSOther

Sperm selection using MACS for selecting sperm with lower DNA fragmentation index

MACS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Case must have PGT-A for all of her blastocysts
Males diagnosed with abnormal sperm DNA fragmentation index (\> 20%).

Sponsors & Collaborators

Ganin Fertility Center
Otherlead

Study Sites (1)

Ganin Fertility Center

Cairo, Maadi, 11728, Egypt

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

Eman Hasanen, BSc.
Ganin Fertility Center
PRINCIPAL INVESTIGATOR
Manar Hozayen, MSc.
Ganin Fertility Center
PRINCIPAL INVESTIGATOR
Amr Elshimy, BSc.
Ganin Fertility Center
PRINCIPAL INVESTIGATOR
Hanaa Alkhader, MBBS/MD
Ganin Fertility Center
PRINCIPAL INVESTIGATOR

Enrollment

515 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 6, 2022

First Posted

August 9, 2022

Study Start

August 1, 2022

Actual (reported)

Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (4)

Study Arms (2)

PICSI

MACS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (4)

Study Arms (2)

PICSI

MACS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations