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

NCT04496232 | Completed DMC

• 1 other identifier: GFC-004
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Male Infertility

Keywords

Sperm DNA fragmentation; Second ejaculate; Sperm Selection; PICSI

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Normal SDF

NO INTERVENTION

Using routine semen processing method

Physiological ICSI (PICSI)

ACTIVE COMPARATOR

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

Device: PICSI

Second ejaculate

ACTIVE COMPARATOR

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

Other: Second ejaculate

Interventions

PICSI DEVICE

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

Physiological ICSI (PICSI)

Second ejaculate OTHER

Semen processing by density gradient centrifugation for the second ejaculate

Second ejaculate

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ganin Fertility Center: lead

Study Sites (1)

Ganin Fertility Center

Cairo, Cairo Governorate, 11728, Egypt

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Eman Hasanen

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Radwa Omar

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hanaa Alkhader

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

• Hosam Zaki, MSc, FRCOG

  Ganin Fertility Center

  STUDY DIRECTOR

• Manar Hozayen, MSc.

  Ganin Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc.

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)