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

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

Study Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Device: PICSI; Other: Second ejaculate

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • القاهرة
    • Cairo, القاهرة, Egypt, 11728
      • Ganin Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal SDF; Using routine semen processing method
Active Comparator: Physiological ICSI (PICSI); Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI	Device: PICSI; Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Active Comparator: Second ejaculate; Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI	Other: Second ejaculate; Semen processing by density gradient centrifugation for the second ejaculate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Defined as the proportion of fertilized oocytes over the injected oocytes.	16-19 hours
Cleavage rate	Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.	3 days
Blastulation rate	Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.	5-6 days
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

Collaborators and Investigators

• Sponsor: Ganin Fertility Center
• Investigators: Principal Investigator: Eman Hasanen, Ganin Fertility Center; Study Director: Hosam Zaki, MSc, FRCOG, Ganin Fertility Center; Principal Investigator: Radwa Omar, Ganin Fertility Center; Principal Investigator: Hanaa Alkhader, Ganin Fertility Center; Principal Investigator: Manar Hozayen, MSc., Ganin Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 6, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Sperm DNA fragmentation; PICSI; Sperm Selection; Second ejaculate
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: GFC-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No