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

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496232
• Other study ID #: GFC-004
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: August 2022
• Source: Ganin Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

Device:
• PICSI
Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate

Other:
• Second ejaculate
Semen processing by density gradient centrifugation for the second ejaculate

Locations

Country	Name	City	State
Egypt	Ganin Fertility Center	Cairo	???????

Sponsors (1)

Lead Sponsor	Collaborator
Ganin Fertility Center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Defined as the proportion of fertilized oocytes over the injected oocytes.	16-19 hours
Primary	Cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.	3 days
Primary	Blastulation rate	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.	5-6 days
Primary	Blastocyst quality rate	Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair, or bad in terms of percentage of the total formed blastocysts.	5-6 days