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

Not Applicable

Completed

• Conditions: Male Infertility
• Interventions: Device: PICSI; Other: Second ejaculate

• Registration Number: NCT04496232
• Lead Sponsor: Ganin Fertility Center

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study Start: 2020-08-01
• Study First Posted: 2020-08-03
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-06
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiological ICSI (PICSI)	PICSI	Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
Second ejaculate	Second ejaculate	Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI

Primary Outcome Measures

Name	Time	Method
Cleavage rate	3 days	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Fertilization rate	16-19 hours	Defined as the proportion of fertilized oocytes over the injected oocytes.
Blastulation rate	5-6 days	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Blastocyst quality rate	5-6 days	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.

Trial Locations

Locations (1)

Ganin Fertility Center; 🇪🇬 Cairo, القاهرة, Egypt