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

Ganin Fertility Center

Status: Completed

Conditions: Infertility, Male

Treatments: Other: Physiological ICSI; Other: Testicular sperm; Other: Magnetic activated cell sorting; Other: Density Gradient Centrifugation

Study type: Interventional

Funder types: Other

Identifiers

NCT04482517

MH-005

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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320 participants in 4 patient groups

Density Gradient Centrifugation (DGC)

Other group

Description:

Using the routine DGC sperm processing only

Treatment:

Other: Density Gradient Centrifugation

Physiological ICSI (PICSI)

Active Comparator group

Description:

Using PICSI dish for selecting sperm with lower sperm DNA fragmentation

Treatment:

Other: Physiological ICSI

Magnetic Activated Cell Sorting (MACS)

Active Comparator group

Description:

Using MACS for selecting sperm with lower sperm DNA fragmentation

Treatment:

Other: Magnetic activated cell sorting

Testicular sperm (Testi)

Active Comparator group

Description:

Using testicular sperm not ejaculated sperm

Treatment:

Other: Testicular sperm