Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial

Ganin Fertility Center

Status: Completed

Conditions: Male Infertility

Treatments: Other: Second ejaculate; Device: PICSI

Study type: Interventional

Funder types: Other

Identifiers

NCT04496232

GFC-004

Details and patient eligibility

About

Comparing second ejaculate and physiological ICSI (PICSI) as strategies for improvement of abnormal sperm DNA fragmentation in patients undergoing ICSI.

Full description

Sperm DNA fragmentation has shown a negative correlation with embryo quality, fertilization, implantation, clinical pregnancy, and live birth rates. And a positive correlation with the miscarriage rate. Abnormal sperm DNA fragmentation can be improved through the second ejaculate strategy, by limiting the time of sperm presence in the epididymis. PICSI is a robust sperm selection technique that can select individual mature intact sperm DNA. In our study, we will compare PICSI as a valid sperm selection technique to second ejaculate, as a natural cost-free strategy to manage abnormal SDF. In addition to a normal SDF arm as a control.

Enrollment: 300 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male partner with abnormal sperm DNA fragmentation index (>20%) by TUNEL assay
• Male partner with at least 1 million progressive motile count
• Male aged 18-50 years
• Male with adjusted sexual abstinence days (1-2 days)
• Female aged 18-37 years
• Normo-responder females (at least 5 mature oocytes)

Exclusion criteria

• Leukocytospermia
• Varicocele
• Known genetic abnormality
• Use of oocyte or sperm donors
• Use of a gestational carrier
• Presence of any endometrial factors that can affect embryo implantation
• Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups

Normal SDF

No Intervention group

Description:

Using routine semen processing method

Physiological ICSI (PICSI)

Active Comparator group

Description:

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

Treatment:

Device: PICSI

Second ejaculate

Active Comparator group

Description:

Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI

Treatment:

Other: Second ejaculate