Infertility
Conditions
Brief summary
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
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.
Interventions
OTHERSlow Freezing and Thawing
half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI
Sponsors
Reproductive Medicine Associates of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blastulation Rate | 5-7 days post ICSI procedure | total number of embryos reaching the blastulation stage of development |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertilization Rate | 1 day post ICSI | number of 2PNs |
| Time to Find Sperm in Fresh Specimen | up to 6 hours post surgery | total amount of time spent finding sperm in the fresh surgical testicular sperm sample |
| Post-thaw recovery rate of frozen surgical sperm | 30 minutes after freezing | analysis of sperm parameters post freezing |
| Aneuploidy Rate | 2 weeks post trophectoderm biopsy | number of chromosomally normal and abnormal embryos |
| Implantation Rate | approximately 4-6 weeks post embryo transfer | presence of fetal heart beat at discharge to obstetric care |
Countries
United States
Outcome results
None listed