Clinical trial NCT03361982: Fresh Vs Frozen Surgical Sperm in IVF
Official title: Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Blastulation Rate
timeFrame: 5-7 days post ICSI procedure
Secondary outcomes:
measure: Fertilization Rate
timeFrame: 1 day post ICSI
measure: Time to Find Sperm in Fresh Specimen
timeFrame: up to 6 hours post surgery
measure: Post-thaw recovery rate of frozen surgical sperm
timeFrame: 30 minutes after freezing
measure: Aneuploidy Rate
timeFrame: 2 weeks post trophectoderm biopsy
measure: Implantation Rate
timeFrame: approximately 4-6 weeks post embryo transfer
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Ashley Tiegs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine LA, Dimitriou RJ, Fakouri B. Testicular and epididymal percutaneous sperm aspiration in men with either obstructive or nonobstructive azoospermia. Urology. 2003 Aug;62(2):328-32. doi: 10.1016/s0090-4295(03)00374-1.
citation: Cui X, Ding P, Gao G, Zhang Y. Comparison of the Clinical Outcomes of Intracytoplasmic Sperm Injection Between Spermatozoa Retrieved From Testicular Biopsy and From Ejaculate in Cryptozoospermia Patients. Urology. 2017 Apr;102:106-110. doi: 10.1016/j.urology.2016.08.071. Epub 2016 Nov 25.
citation: Ben-Ami I, Raziel A, Strassburger D, Komarovsky D, Ron-El R, Friedler S. Intracytoplasmic sperm injection outcome of ejaculated versus extracted testicular spermatozoa in cryptozoospermic men. Fertil Steril. 2013 Jun;99(7):1867-71. doi: 10.1016/j.fertnstert.2013.02.025. Epub 2013 Mar 13.
citation: Pabuccu EG, Caglar GS, Tangal S, Haliloglu AH, Pabuccu R. Testicular versus ejaculated spermatozoa in ICSI cycles of normozoospermic men with high sperm DNA fragmentation and previous ART failures. Andrologia. 2017 Mar;49(2). doi: 10.1111/and.12609. Epub 2016 Apr 25.
citation: Ohlander S, Hotaling J, Kirshenbaum E, Niederberger C, Eisenberg ML. Impact of fresh versus cryopreserved testicular sperm upon intracytoplasmic sperm injection pregnancy outcomes in men with azoospermia due to spermatogenic dysfunction: a meta-analysis. Fertil Steril. 2014 Feb;101(2):344-9. doi: 10.1016/j.fertnstert.2013.10.012. Epub 2013 Dec 9.
citation: Forman EJ, Li X, Ferry KM, Scott K, Treff NR, Scott RT Jr. Oocyte vitrification does not increase the risk of embryonic aneuploidy or diminish the implantation potential of blastocysts created after intracytoplasmic sperm injection: a novel, paired randomized controlled trial using DNA fingerprinting. Fertil Steril. 2012 Sep;98(3):644-9. doi: 10.1016/j.fertnstert.2012.04.028. Epub 2012 May 17.