Advanced Sperm Selection Techniques and Their Contribution to Blastocyst Euploidy Rates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

515 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-01-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Sperm DNA Fragmentation Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PICSI

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

Group Type ACTIVE_COMPARATOR

PICSI

Intervention Type OTHER

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

MACS

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.

Group Type ACTIVE_COMPARATOR

MACS

Intervention Type OTHER

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

Interventions

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PICSI

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

Intervention Type OTHER

MACS

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No