Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)

NCT06566599 | Active Not Recruiting

• 1 other identifier: INC-IIS-2024-005
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: To examine the rate of embryo aneuploidy in patients with non-obstructive azoospermia (NOA) who utilize in-vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) and compare live birth rates with the utilization of preimplantation genetic testing for aneuploidy (PGT-A) vs non PGT-A.

Conditions

Non-obstructive Azoospermia; Male Infertility

Keywords

IVF; PGT-A; TESE; PESE

Outcome Measures

Primary Outcomes (2)

• Aneuploidy rate

  Frequency of aneuploidy result in embryos

  1 year

• Chromosomes associated with aneuploidy

  Compare types of embryonic aneuploidy in male factor patients to advanced maternal age patients

  1 year

Secondary Outcomes (3)

• Live birth rate

  1 year

• Clinical pregnancy rate

  1 year

• Fertilization rate

  1 year

Eligibility Criteria

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

Study Population

Couples who have undergone IVF/ICSI with or without pre-implantation genetic testing for aneuploidy (PGT-A) at a fertility clinic in The Prelude Network (US sites only).

You may qualify if:

• Couples who have undergone in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) with or without pre-implantation genetic testing for aneuploidy (PGT-A) at a fertility clinic in The Prelude Network (US sites only).
• Male partner has diagnosis of non-obstructive azoospermia or obstructive azoospermia.
• Male partner has undergone surgical sperm extraction.

You may not qualify if:

• not applicable

Sponsors & Collaborators

• Inception Fertility Research Institute, LLC: lead

Study Sites (1)

Inception Fertility Research Institute

Houston, Texas, 77081, United States

Location

Related Publications (8)

• Munne S, Kaplan B, Frattarelli JL, Child T, Nakhuda G, Shamma FN, Silverberg K, Kalista T, Handyside AH, Katz-Jaffe M, Wells D, Gordon T, Stock-Myer S, Willman S; STAR Study Group. Preimplantation genetic testing for aneuploidy versus morphology as selection criteria for single frozen-thawed embryo transfer in good-prognosis patients: a multicenter randomized clinical trial. Fertil Steril. 2019 Dec;112(6):1071-1079.e7. doi: 10.1016/j.fertnstert.2019.07.1346. Epub 2019 Sep 21.

  PMID: 31551155 BACKGROUND

• Yatsenko AN, Yatsenko SA, Weedin JW, Lawrence AE, Patel A, Peacock S, Matzuk MM, Lamb DJ, Cheung SW, Lipshultz LI. Comprehensive 5-year study of cytogenetic aberrations in 668 infertile men. J Urol. 2010 Apr;183(4):1636-42. doi: 10.1016/j.juro.2009.12.004. Epub 2010 Feb 20.

  PMID: 20172548 BACKGROUND

• Ravel C, Berthaut I, Bresson JL, Siffroi JP; Genetics Commission of the French Federation of CECOS. Prevalence of chromosomal abnormalities in phenotypically normal and fertile adult males: large-scale survey of over 10,000 sperm donor karyotypes. Hum Reprod. 2006 Jun;21(6):1484-9. doi: 10.1093/humrep/del024. Epub 2006 Feb 16.

  PMID: 16484311 BACKGROUND

• Calogero AE, Burrello N, De Palma A, Barone N, D'Agata R, Vicari E. Sperm aneuploidy in infertile men. Reprod Biomed Online. 2003 Apr-May;6(3):310-7. doi: 10.1016/s1472-6483(10)61850-0.

  PMID: 12735865 BACKGROUND

• Rodrigo L, Meseguer M, Mateu E, Mercader A, Peinado V, Bori L, Campos-Galindo I, Milan M, Garcia-Herrero S, Simon C, Rubio C. Sperm chromosomal abnormalities and their contribution to human embryo aneuploidy. Biol Reprod. 2019 Dec 24;101(6):1091-1101. doi: 10.1093/biolre/ioz125.

  PMID: 31318411 BACKGROUND

• Asoglu MR, Celik C, Serefoglu EC, Findikli N, Bahceci M. Preimplantation genetic testing for aneuploidy in severe male factor infertility. Reprod Biomed Online. 2020 Oct;41(4):595-603. doi: 10.1016/j.rbmo.2020.06.015. Epub 2020 Jun 27.

  PMID: 32763130 BACKGROUND

• Platteau P, Staessen C, Michiels A, Tournaye H, Van Steirteghem A, Liebaers I, Devroey P. Comparison of the aneuploidy frequency in embryos derived from testicular sperm extraction in obstructive and non-obstructive azoospermic men. Hum Reprod. 2004 Jul;19(7):1570-4. doi: 10.1093/humrep/deh306. Epub 2004 May 13.

  PMID: 15142999 BACKGROUND

• Kahraman S, Sahin Y, Yelke H, Kumtepe Y, Tufekci MA, Yapan CC, Yesil M, Cetinkaya M. High rates of aneuploidy, mosaicism and abnormal morphokinetic development in cases with low sperm concentration. J Assist Reprod Genet. 2020 Mar;37(3):629-640. doi: 10.1007/s10815-019-01673-w. Epub 2020 Jan 4.

  PMID: 31901112 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)