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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

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

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

NCT ID

NCT04496232

First Posted

July 29, 2020

Last Updated

August 6, 2022

Sponsor

Ganin Fertility Center

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

Studies a U.S. FDA-regulated Device Product

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

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: