Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Primary Purpose
Male Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
PICSI
Second ejaculate
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI
Eligibility Criteria
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
Sites / Locations
- Ganin Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Normal SDF
Physiological ICSI (PICSI)
Second ejaculate
Arm Description
Using routine semen processing method
Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI
Outcomes
Primary Outcome Measures
Fertilization rate
Defined as the proportion of fertilized oocytes over the injected oocytes.
Cleavage rate
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Blastulation rate
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04496232
Brief Title
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Official Title
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ganin Fertility Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal SDF
Arm Type
No Intervention
Arm Description
Using routine semen processing method
Arm Title
Physiological ICSI (PICSI)
Arm Type
Active Comparator
Arm Description
Sperm selection using PICSI dishes for selecting sperm with lower DNA fragmentation index for ICSI
Arm Title
Second ejaculate
Arm Type
Active Comparator
Arm Description
Using the second ejaculate as a way of reducing SDF in the semen sample used for ICSI
Intervention Type
Device
Intervention Name(s)
PICSI
Intervention Description
Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
Intervention Type
Other
Intervention Name(s)
Second ejaculate
Intervention Description
Semen processing by density gradient centrifugation for the second ejaculate
Primary Outcome Measure Information:
Title
Fertilization rate
Description
Defined as the proportion of fertilized oocytes over the injected oocytes.
Time Frame
16-19 hours
Title
Cleavage rate
Description
Defined as the proportion of cleaved embryos on day 3 over the injected oocytes.
Time Frame
3 days
Title
Blastulation rate
Description
Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3.
Time Frame
5-6 days
Title
Blastocyst quality rate
Description
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.
Time Frame
5-6 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Hasanen
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Radwa Omar
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanaa Alkhader
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hosam Zaki, MSc, FRCOG
Organizational Affiliation
Ganin Fertility Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Manar Hozayen, MSc.
Organizational Affiliation
Ganin Fertility Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ganin Fertility Center
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11728
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Strategies for Reducing Sperm DNA Fragmentation in ICSI Semen Samples: a Prospective Randomized Controlled Trial
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