Reproductive Outcomes of Different Sperm Selection Techniques for ICSI Patients With Abnormal Sperm DNA Fragmentation.

Study Overview
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Brief Summary
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Comparing the reproductive outcomes of different sperm selection techniques; Density gradient centrifugation (DGC), Testicular sperm (Testi), Physiological ICSI (PICSI), and Magnetic activated cell sorting (MACS) in abnormal sperm DNA fragmentation (SDF) ICSI patients.

Official Title
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Reproductive Outcomes of Different Sperm Selection Techniques; Density Gradient Centrifugation, Testicular Sperm, PICSI, and MACS for ICSI Patients With Abnormal Sperm DNA Fragmentation

Conditions
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Infertility, Male

Intervention / Treatment
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* Other: Density Gradient Centrifugation
* Other: Physiological ICSI
* Other: Magnetic activated cell sorting
* Other: Testicular sperm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female age was ≤37 years Female should has 5≥ metaphase II oocytes Males having abnormal SDF levels ≥ 20.3% by TUNEL assay Abstinence from 1 to 2 days Males having at least 1 million total motile progressive count Exclusion Criteria: Leukocytospermia Presence of varicocele. Known genetic abnormality Use of sperm donation or cryopreserved sperm Use of Oocyte donation Use of gestational carrier Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previous uterine infection Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Density Gradient Centrifugation (DGC)<br>Using the routine DGC sperm processing only | Other: Density Gradient Centrifugation<br>* Semen processing is done by double layer density gradient method.<br>* Other names: DGC;|
| Active Comparator: Physiological ICSI (PICSI)<br>Using PICSI dish for selecting sperm with lower sperm DNA fragmentation | Other: Physiological ICSI<br>* Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head<br>* Other names: PICSI;|
| Active Comparator: Magnetic Activated Cell Sorting (MACS)<br>Using MACS for selecting sperm with lower sperm DNA fragmentation | Other: Magnetic activated cell sorting<br>* Sperm selection by using Annexin V micro-beads and separation columns<br>* Other names: MACS;|
| Active Comparator: Testicular sperm (Testi)<br>Using testicular sperm not ejaculated sperm | Other: Testicular sperm<br>* Using testicular sperm retrieved by TESA or TESE<br>* Other names: Testi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Defined as clinical pregnancy per transfer | 14 days following embryo transfer | 
| Implantation rate | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo transferred. | 6- 8 weeks following embryo transfer | 
| Ongoing pregnancy rate | Defined as the proportion of pregnancies that completed more than 20 weeks of gestation | 20 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| High quality blastocyst 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 | 
| Miscarriage rate | Defined as the proportion of miscarried cases | 20 weeks of gestation | 

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