Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction

Study Overview
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Brief Summary
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In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods rely on physical properties of the spermatozoa, such as the swim-up methods and density gradient centrifugation. It is now known that current processing of spermatozoa does not prevent the admixture of spermatozoa with damaged genetic material. The latter have a negative impact on the outcome of ART. The investigators developed a new method for the processing of spermatozoa with intact genetic material based on flow cytometry and sorting (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of this novel method of sperm sorting on the outcome of ART.

Official Title
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The Effect of Sorting of Non-apoptotic and Apoptotic Spermatozoa Using Flow Cytometry on the Outcome of Intracytoplasmic Sperm Injection.

Conditions
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Male Infertility

Intervention / Treatment
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* Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS
* Procedure: Swim-up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: infertile couples needing treatment with ICSI male infertility as defined by the WHO 2010 criteria age of the treated women should be between 22 and 39 years of age. normal ovarian reserve, as defined by basal FSH-concentration below 10 IU/l and AMH-concentration above 10 pmol/l. signed consent form. Exclusion Criteria: normal male infertility, as defined by the WHO 2010 criteria age of the treated women below 22 years and above 39 years reduced ovarian reserve, as defined by an elevated basal FSH-concentration or reduced AMH-concentration. Not more than two preceding unsuccessfull treatments with ICSI Severe disease of the male or female partner, such as HIV, hepatitis, or psychiatric illness. Participation in another study. lack of a signed consent form.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 39 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YoPro and FACS<br>Spermatozoa to be used for ICSI will be stained with the YoPro Dye and then be sorted with FACS to select non-YoPro stained spermatozoa, known to have significantly less fragmented DNA. | Procedure: Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS<br> <br> * Other names: FACS;|
| Active Comparator: Swim-up<br>Spermatozoa will be processed using the conventional swim-up me | Procedure: Swim-up<br>* Semen processing will be carried out with the conventional swim-up method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate |  | Week 12 of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of diploidic fertilized oocytes. |  | one day after intracytoplasmic sperm injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male infertility, apoptosis, flow cytometry and sorting, DNA fragmentation, intracytoplasmic sperm injection