Status:
TERMINATED
Fresh Vs Frozen Surgical Sperm in IVF
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Conditions:
Infertility
Eligibility:
All Genders
Phase:
NA
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 testic...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03361982
Start Date
October 25 2019
End Date
December 31 2021
Last Update
January 28 2022
Active Locations (1)
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1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920