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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
Ganin Fertility Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 29, 2020
Last Updated
August 6, 2022
Sponsor
Ganin Fertility Center
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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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