Testicular Versus Ejaculated Spermatozoa for IVF/ICSI in Men With High Sperm DNA Damage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether couples undergoing IVF/ICSI with male factor infertility, specifically with elevated sperm DNA damage, should testicular sperm extraction be utilized to improve their reproductive outcomes.

Official Title
-----------------
Randomized Control Trial on the Use of Testicular Versus Ejaculated Spermatozoa for IVF/ICSI on Pregnancy Outcomes for Men With High Sperm DNA Damage

Conditions
-----------------
Infertility, Male, DNA Damage

Intervention / Treatment
-----------------
* Procedure: Intracytoplasmic sperm injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age be considered infertile (>1 year of unsuccessful attempts of conception Any race Male partner with persistent sperm DNA damage, DFI>=30% candidates for intracytoplasmic sperm injection (ICSI) Exclusion Criteria: significant female factor infertility contributing to the couple's infertility female partner older than 38 years male or female patients with genetic abnormalities patients unable or unwilling to give consent after properly informed couples unsuitable for IVF/ICSI male patients in whom testicular procedures were contraindicated

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ejaculated sperm<br>Intracytoplasmic sperm injection (ICSI) cycles using ejaculated sperm | Procedure: Intracytoplasmic sperm injection<br> <br> |
| Active Comparator: testicular extracted sperm<br>Intracytoplasmic sperm injection (ICSI) cycles using testicular extracted sperm | Procedure: Intracytoplasmic sperm injection<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rates |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm DNA damage |  | Mesaured at baseline, 3 months and on the day of Intracytoplasmic sperm injection (ICSI) procedure | 
| oocyte fertilization rates |  | at approximately 18 hrs post Intracytoplasmic sperm injection (ICSI) | 
| embryo cleavage rate |  | Day 3 post oocytes retrieval | 
| blastocyst rate |  | Day 5 post oocytes retrieval | 
| pregnancy rate | Clinical pregnancy was defined as the ultrasonographic visualization of one or more gestational sacs and fetal heart at the 6 to 8 week ultrasound | 6 to 8 week ultrasound | 
| rate of spontaneous abortion |  | after a clinical pregnancy has been established, up to 10 months after procedure | 
| birth defects |  | 1-year following delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Failure to Conceive Due to Infertility of Male Partner, DNA Damage