Fresh Vs Frozen Surgical Sperm in IVF

NCT03361982 | Terminated

• 1 other identifier: RMA-2017-06
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate

  total number of embryos reaching the blastulation stage of development

  5-7 days post ICSI procedure

Secondary Outcomes (5)

• Fertilization Rate

  1 day post ICSI

• Time to Find Sperm in Fresh Specimen

  up to 6 hours post surgery

• Post-thaw recovery rate of frozen surgical sperm

  30 minutes after freezing

• Aneuploidy Rate

  2 weeks post trophectoderm biopsy

• Implantation Rate

  approximately 4-6 weeks post embryo transfer

Study Arms (2)

Fresh surgical testicular sperm

NO INTERVENTION

Fresh, surgically obtained testicular sperm

Frozen surgical testicular sperm

EXPERIMENTAL

Surgically obtained testicular sperm that will undergo slow freezing and thawing

Other: Slow Freezing and Thawing

Interventions

Slow Freezing and Thawing OTHER

half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI

Frozen surgical testicular sperm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (6)

• 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.

  PMID: 12893345 BACKGROUND

• 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.

  PMID: 27894976 BACKGROUND

• 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.

  PMID: 23490166 BACKGROUND

• 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.

  PMID: 27108915 BACKGROUND

• 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.

  PMID: 24345355 BACKGROUND

• 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.

  PMID: 22608316 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Ashley Tiegs, MD

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 5, 2017
• Study Start: October 25, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)