Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

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

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-12-01

Brief Summary

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Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.

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Detailed Description

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Conditions

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Infertility, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Density Gradient Centrifugation (DGC)

Using the routine DGC sperm processing only

Group Type OTHER

Density Gradient Centrifugation

Intervention Type OTHER

Semen processing is done by double layer density gradient method.

Physiological ICSI (PICSI)

Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Group Type ACTIVE_COMPARATOR

Physiological ICSI

Intervention Type OTHER

Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head

Magnetic Activated Cell Sorting (MACS)

Using MACS for selecting sperm with lower sperm DNA fragmentation

Group Type ACTIVE_COMPARATOR

Magnetic activated cell sorting

Intervention Type OTHER

Sperm selection by using Annexin V micro-beads and separation columns

Testicular sperm (Testi)

Using testicular sperm not ejaculated sperm

Group Type ACTIVE_COMPARATOR

Testicular sperm

Intervention Type OTHER

Using testicular sperm retrieved by TESA or TESE

Interventions

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Density Gradient Centrifugation

Semen processing is done by double layer density gradient method.

Intervention Type OTHER

Physiological ICSI

Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head

Intervention Type OTHER

Magnetic activated cell sorting

Sperm selection by using Annexin V micro-beads and separation columns

Intervention Type OTHER

Testicular sperm

Using testicular sperm retrieved by TESA or TESE

Intervention Type OTHER

Other Intervention Names

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DGC PICSI MACS Testi

Eligibility Criteria

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Inclusion Criteria

* Female age was ≤37 years
* Female should has 5≥ metaphase II oocytes
* Males having abnormal SDF levels ≥ 20.3% by TUNEL assay
* Abstinence from 1 to 2 days
* Males having at least 1 million total motile progressive count

Exclusion Criteria

* Leukocytospermia
* Presence of varicocele.
* Known genetic abnormality
* Use of sperm donation or cryopreserved sperm
* Use of Oocyte donation
* 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

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No