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AzTrials

Non-obstructive AzoospermiaNCT06566599

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

An observational study of Non-obstructive Azoospermia and Male Infertility, run by Inception Fertility Research Institute, LLC at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Non-obstructive Azoospermia, Male Infertility
How many people
400 participants
Where
1 siteUnited States
Study dates
19 Aug 2024to Apr 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • not applicable

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inception Fertility Research Institute

    Houston, Texas, 77081

Other trials in United States

About this study

Official title: A Retrospective Review of the Utilization of Preimplantation Genetic Testing for Aneuploidy (PGT-A) in Couples With Non-obstructive Azoospermia (NOA)

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.

Read the detailed description

Preimplantation genetic testing for aneuploidy (PGT-A) facilitates selection of euploid embryos for transfer and may improve outcomes in select couples when the female partner is 35 or older. While embryonic aneuploidy is known to be associated with maternal risk factors such as advanced age, the male factors contributing to aneuploidy are not as clear. Severe male factor infertility is associated with various genetic causes, including karyotypic abnormalities. One retrospective analysis of 668 infertile patients diagnosed with various nonobstructive spermatogenic defects using high resolution Giemsa banding chromosome analysis and/or fluorescence in situ hybridization revealed constitutional chromosomal abnormalities in 55 (8.2%) patients. The observed incidence was almost 20-fold greater than what is reported in healthy fertile men (0.37%). This study correlated cytogenetic aberrations with male reproductive phenotypes and noted that sex chromosome aneuploidy was the most common finding in azoospermia (AS) cases, accounting for about 9%, with Klinefelter syndrome (47, XXY karyotype and variants) accounting for 4% of all infertile males. Notably, the 47, XXY karyotype was detected at a considerably higher rate in men with AS vs oligospermia (OS) (27 of 668 or 9.1% vs 3 of 365 or 0.8%). Little is known about the impact of constitutional aneuploidy on embryonic aneuploidy rates after fertilization with surgically extracted sperm. Another study examined the impact of severe male factor infertility in 326 cycles on aneuploidy in embryos and found significant increases in embryo aneuploidy and higher mosaicism rates in cases using testicular sperm from patients with severe male factor infertility as compared to non-male factor controls. This study found that the statistically significant affected chromosomes were 2, 10, 11, 17, 21 and sex chromosomes. While sperm chromosomal aneuploidy are consistently higher in severe male factor infertility, the impact on IVF outcomes and potential benefits of PGT-A are unclear. Additionally, data on differences in aneuploidy rates between OA and NOA are mixed. Further research is warranted to help facilitate appropriate counseling of affected couples and better understand the role of PGT-A in severe male-factor infertility treatment. We will conduct a retrospective chart review to examine the rates of aneuploidy in embryos resulting from ICSI with surgically extracted sperm in patients with NOA and OA and characterize the chromosomes commonly affected in identified aneuploid embryos.

Keywords
IVF, PGT-A, TESE, PESE
Medical subject headings
Infertility, Male

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aneuploidy rate

    Frequency of aneuploidy result in embryos

    Measured: 1 year

  2. Chromosomes associated with aneuploidy

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

    Measured: 1 year

Secondary outcomes (3)

  1. Live birth rate

    The frequency of live birth following embryo transfer.

    Measured: 1 year

  2. Clinical pregnancy rate

    The frequency of intrauterine pregnancy (IUP) as confirmed by ultrasound post embryo transfer.

    Measured: 1 year

  3. Fertilization rate

    The calculated rate of successful fertilization of egg, defined as presence of 2 pronuclei (2PN) on day 1 check post fertilization, to number of eggs where fertilization was attempted.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start19 Aug 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06566599
Sponsor's protocol ID
INC-IIS-2024-005
Status last verified
Apr 2026
First submitted
20 Aug 2024
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will not be available to other researchers.

Publications

  • 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.

    PubMed 31551155

  • 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.

    PubMed 20172548

  • 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.

    PubMed 16484311

  • 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.

    PubMed 12735865

  • 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.

    PubMed 31318411

  • 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.

    PubMed 32763130

  • 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.

    PubMed 15142999

  • 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.

    PubMed 31901112

Questions about this trial

What is this clinical trial studying?

An observational study of Non-obstructive Azoospermia and Male Infertility, run by Inception Fertility Research Institute, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aneuploidy rate (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06566599, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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