Split Cohort Trial Comparing IVF Outcomes After the Use of Testicular vs. Ejaculated Sperm for ICSI

NCT03483298 | Terminated

• 1 other identifier: RMA-2018-04
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine if there is a difference in in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) outcomes when using testicular sperm versus ejaculated sperm in couples with elevated sperm DNA fragmentation after a failed in vitro fertilization (IVF) cycle

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate of testicular vs. ejaculated sperm after ICSI

  \# blast per 2 pronuclei in each group

  1 week post ICSI

Secondary Outcomes (3)

• Fertilization Rate

  24 hrs post ICSI

• Aneuploidy Rate

  approximately 2 weeks post trophectoderm biopsy

• Clinical Pregnancy Rate

  approximately 2 weeks post pregnancy test

Study Arms (1)

elevated sperm DNA fragmentation

Couples with male partners who will be undergoing a TESA procedure secondary to elevated DNA fragmentation (\>25% DFI) as part of their routine IVF treatment will have half of the women's eggs inseminated with ejaculated sperm and the other half with surgically obtained sperm via the ICSI procedure

Other: ICSI

Interventions

ICSI OTHER

The cryopreserved pre-TESA ejaculate and TESA specimen will be thawed on the day of oocyte retrieval per protocol for ICSI

elevated sperm DNA fragmentation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with Elevated DNA fragmentation noted in ejaculated sperm (\>25% DFI according to the American Society of Reproductive Medicine guidelines) and one prior failed IVF cycle

You may qualify if:

• Willing to comply with all study procedures and be available for the duration of the study
• Failed at least one IVF cycle (i.e., no live birth)
• Elevated DNA fragmentation noted in ejaculated sperm (\>25% DFI according to the American Society of Reproductive Medicine guidelines)
• Couple electing single embryo transfer
• Couples electing comprehensive chromosome screening (CCS) of embryos
• At least 4 oocytes retrieved in IVF cycle in order to randomize

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)
• Male partner with azoospermia (\<100,000 motile spermatozoa)
• Male partner with Y-chromosome microdeletion
• Male partner with any Karyotype other than 46,XY(normal male karyotype)
• Female partner history of hydrosalpinges or adnexal mass
• Female partner history of endometrial insufficiency (max endometrial thickness \< 7mm)
• Female partner BMI \< 35

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead

Study Sites (1)

IVI RMA New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (6)

• Esteves SC, Sanchez-Martin F, Sanchez-Martin P, Schneider DT, Gosalvez J. Comparison of reproductive outcome in oligozoospermic men with high sperm DNA fragmentation undergoing intracytoplasmic sperm injection with ejaculated and testicular sperm. Fertil Steril. 2015 Dec;104(6):1398-405. doi: 10.1016/j.fertnstert.2015.08.028. Epub 2015 Oct 1.

  PMID: 26428305 BACKGROUND

• Greco E, Scarselli F, Iacobelli M, Rienzi L, Ubaldi F, Ferrero S, Franco G, Anniballo N, Mendoza C, Tesarik J. Efficient treatment of infertility due to sperm DNA damage by ICSI with testicular spermatozoa. Hum Reprod. 2005 Jan;20(1):226-30. doi: 10.1093/humrep/deh590. Epub 2004 Nov 11.

  PMID: 15539441 BACKGROUND

• Bradley CK, McArthur SJ, Gee AJ, Weiss KA, Schmidt U, Toogood L. Intervention improves assisted conception intracytoplasmic sperm injection outcomes for patients with high levels of sperm DNA fragmentation: a retrospective analysis. Andrology. 2016 Sep;4(5):903-10. doi: 10.1111/andr.12215. Epub 2016 May 27.

  PMID: 27231097 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

• Mehta A, Bolyakov A, Schlegel PN, Paduch DA. Higher pregnancy rates using testicular sperm in men with severe oligospermia. Fertil Steril. 2015 Dec;104(6):1382-7. doi: 10.1016/j.fertnstert.2015.08.008. Epub 2015 Sep 9.

  PMID: 26363389 BACKGROUND

• Lewis SE, John Aitken R, Conner SJ, Iuliis GD, Evenson DP, Henkel R, Giwercman A, Gharagozloo P. The impact of sperm DNA damage in assisted conception and beyond: recent advances in diagnosis and treatment. Reprod Biomed Online. 2013 Oct;27(4):325-37. doi: 10.1016/j.rbmo.2013.06.014. Epub 2013 Jul 11.

  PMID: 23948450 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum obtained from male patient

MeSH Terms

Conditions

Infertility

Interventions

Sperm Injections, Intracytoplasmic

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Fertilization in Vitro; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Phil Cheng, MD

  IVI RMA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: June 23, 2018
• 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)