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

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

Detailed Description
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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.

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

Conditions
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Male Infertility

Intervention / Treatment
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* Device: PICSI
* Other: Second ejaculate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sperm DNA fragmentation, Second ejaculate, Sperm Selection, PICSI