Fresh Vs Frozen Surgical Sperm in IVF

Study Overview
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Brief Summary
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The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.

Detailed Description
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The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.

Official Title
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Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles

Conditions
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Infertility

Intervention / Treatment
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* Other: Slow Freezing and Thawing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females age < 42 with an indication for IVF Females with lowest AMH level 1.2 ng/mL or higher Females with FSH < 13 mIU/mL Sperm obtained via Surgical retrieval (any type) for IVF only Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy BMI < 35 Baseline antral follicle count of > 8 Single embryo transfers only Exclusion Criteria: Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study. Contraindication to IVF Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis) Fewer than 4 mature oocytes retrieved (will not randomize) Male partner with non-obstructive azoospermia Male partner with any Karyotype other than 46,XY Male partner with history of spinal cord injury Male partner with Kallman's syndrome History of chronic oligomenorrhea History of hydrosalpinges or adnexal mass History of endometrial insufficiency (max endometrial thickness < 7mm)
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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Fresh surgical testicular sperm<br>Fresh, surgically obtained testicular sperm | |
| Experimental: Frozen surgical testicular sperm<br>Surgically obtained testicular sperm that will undergo slow freezing and thawing | Other: Slow Freezing and Thawing<br>* half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastulation Rate | total number of embryos reaching the blastulation stage of development | 5-7 days post ICSI procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization Rate | number of 2PNs | 1 day post ICSI | 
| Time to Find Sperm in Fresh Specimen | total amount of time spent finding sperm in the fresh surgical testicular sperm sample | up to 6 hours post surgery | 
| Post-thaw recovery rate of frozen surgical sperm | analysis of sperm parameters post freezing | 30 minutes after freezing | 
| Aneuploidy Rate | number of chromosomally normal and abnormal embryos | 2 weeks post trophectoderm biopsy | 
| Implantation Rate | presence of fetal heart beat at discharge to obstetric care | approximately 4-6 weeks post embryo transfer |