Male Sterility Due to Y-chromosome DeletionsNCT02527954
Aneuploidies in Embryos and Spermatozoa From Patients With Y-chromosome Microdeletions
An observational study of Male Sterility Due to Y-chromosome Deletions, run by Instituto Valenciano de Infertilidad, IVI Alicante at 3 sites in Spain.
Trial summary
In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Male Sterility Due to Y-chromosome Deletions
- How many people
- 5 participants
- Where
- 3 sitesSpain
- Study dates
- 22 Sep 2015to 11 Jun 2018
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples undergoing "In vitro" Fertilization (IVF) treatment whose man has non-obstructive azoospermia or severe oligozoospermia (≤ 5x1000000 spermatozoa/ml) and consent the genetic analysis of semen samples, as well as the embryo cohort generated by ICSI.
Who may be able to join
- Couples with male infertility whose man has non-obstructive azoospermia or severe oligozoospermia with ≤5x1000000 spermatozoa/ml.
- Assisted Reproductive Technology: ICSI with motile spermatozoa and PGS by CGH arrays.
- Women <38 years if microinjection is carried out in their own eggs, or 38≤ age <50 years if they receive donated eggs.
- Women with body mass index (BMI)<30.
- Men<50 years
Who cannot join
- Couples with abnormal karyotypes.
- Women with any uterine pathology or abnormality, hydrosalpinx, thrombophilia or systemic diseases at the time of embryo transfer that could prejudge the outcome of the cycle
- Couples with repeated miscarriages (≥2) or implantation failures (≥2).
- Couples whose men has obstructive azoospermia, genital tract infections (mumps, inflammation, varicocele), cryptorchidism, or if he receives any treatment that can reduce the sperm count.
- Seminal samples processed by Magnetic Activated Cell Sorting (MACS) technique.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
IVI Alicante
Alicante, 03015
IVI Murcia
Murcia, 03007
Igenomix
Valencia, 41980
About this study
Official title: Impact of Y-chromosome Microdeletions From Infertile Men on the Chromosomal Constitution of Their Spermatozoa and Embryos. Combined IntraCytoplasmatic Sperm Injection (ICSI) and Preimplantation Genetic Screening (PGS) as Treatment Strategy.
In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted reproduction in their clinics.
Read the detailed description
Nowadays, Y-chromosome microdeletions are one of the most common causes of male infertility. With a frequency of 8-20% in non-obstructive azoospermic men and 3-14% in severe oligozoospermic men, is the most usual chromosome anomaly associated with failure in sperm production, although the frequency seems to change due to differences in the experimental designs, the ethnic differences, the genetic background, or even environmental influences.
The absence of some genes located on certain regions in the long arm of the human Y chromosome, known as the azoospermia factor region (AZF), causes spermatogenic failure, while spermatozoa has been found in either the ejaculate or the testicle of most patients. Detection of deletions is crucial for the medical treatment of these patients, since it has a prognostic value in predicting potential success of testicular sperm retrieval in azoospermic patients with certain microdeletions, and allows avoiding invasive techniques in oligozoospermic patients whose sperm production could result in progressive worsening.
The development of assisted reproduction techniques, such as intracytoplasmatic sperm injection (ICSI), together with testicular or epididymis sperm retrieval for azoospermic men has allowed these patients to become fathers using their own gametes. Although the effect of Y-chromosome microdeletions on ICSI outcome is controversial, the ability to vertically transmit that genetic defect, and so the infertility, to the offspring has been accepted. Until recently, no clinical consequences other than infertility were supposed in the ICSI-conceived sons of fathers with deletions. However, different studies in the last years, suggest other potentially risks transmitted to the offspring, such as the development of sexual dysfunction due to sex chromosome abnormalities (Turner or Klinefelter syndromes, etc.) or other somatic disorders with worse health implications caused by chromosome aberrations outside the AZF regions or in autosomes that has been associated to Y-chromosome microdeletions. No major clinical complications than infertility has been described in the offspring born from fathers with deletions to date, but it is important to remember that the first generation of those babies, mainly obtained by ICSI, has just reached maturity. Moreover, the mentioned chromosome anomalies, could stop embryo development or increase miscarriage rate. Few studies focused in the incidence of miscarriages in these couples but microdeletions have been detected more frequents in men from couples with recurrent pregnancy loss.
In order to offer fully genetic counseling to these couples, further studies focusing on the relationship between Y-chromosome microdeletions and other chromosomal abnormalities, which also provide information about their consequences in their embryos, are required. Thus, the actual risk of transmitting different anomalies associated to microdeletions to those embryos will be clarified, increasing the chances of a successful pregnancy and live birth.
In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted reproduction in their clinics.
- Keywords
- Y-chromosome microdeletions, aneuploidy, embryos, spermatozoa
- Medical subject headings
- Male sterility due to Y-chromosome deletions, Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infertile with Y-chromosome deletions | No intervention will be performed. Couples whose infertile men has a Y-chromosome microdeletion (detected in blood cells by Polymerase chain reaction multiplex) and fulfill the criteria will be included in this group (group 1) | |
| Infertile without Y-chromosome deletions | No intervention will be performed. Couples whose infertile men has not any Y-chromosome microdeletion (detected in blood cells by polymerase chain reaction multiplex) and fulfill the criteria will be included in this group (group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Embryos with aneuploidies
The incidence of embryonic aneuploidies will be examined by CGH arrays analysis after biopsy in day 3 or day 5 of embryo development. This technology allows the analysis of all the chromosomes, so both aneuploidies in gonosomes and autosomes will be determined.
To measure these percentages the images obtained after CGH array will be analyzed by BlueFuse Software (BlueGnome, Cambridge, UK), identifying normal euploid embryos, embryos with full or partial aneuploidy and chaotic embryos.
Measured: three years
Secondary outcomes (12)
% Spermatozoa with aneuploidies
The incidence of aneuploidy (%) in sperm will be examined by FISH, analyzing chromosomes 13, 18, 21, X and Y.
To measure these percentages two examiners will analyze 2000 spermatozoa in each sample.
Measured: Three years
Fertilization rate (%)
nº fertilized oocytes/ nº metaphase II oocytes
Measured: three years
Day 3 embryos rate (%)
nº embryos at day 3/ nº fertilized oocytes
Measured: Three years
Blastocyst rate (%)
nº blastocyst/ nº fertilized oocytes
Measured: Three years
Cycle efficiency
nº transferred embryos + vitrified embryos
Measured: Four years
Pregnancy rate (%)
nº pregnancies/ nº embryos transferred
Measured: Four years
Biochemical pregnancy rate (%)
% of positive pregnancy tests
Measured: Four years
Clinical pregnancy rate (%)
nº pregnancies (proven by the presence of at least 1 embryo with cardiac activity positive by ultrasound after 5-6 weeks of development)/ nº of transfer cycles
Measured: Four years
Implantation rate (%)
nº gestational sacs/ nº transferred embryos
Measured: Four years
Abortion rate (%)
nº miscarriages/ nº pregnancies.
Measured: Four years
Ongoing pregnancy rate (%)
% clinical pregnancies that do not finish in abortion or ectopic pregnancy
Measured: Four years
Live birth rate (%)
Proportion of live birth at home per embryo transferred.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study start22 Sep 2015
- Primary completion11 Jun 2018
- Study completion11 Jun 2018
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Male Sterility Due to Y-chromosome DeletionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 5 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI Alicante
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Murcia, Igenomix
- Responsible party
- Principal investigator, Purificación Hernández, Instituto Valenciano de Infertilidad, IVI Alicante
- Investigators
- Purificación Hernández-Vargas, PhD, Principal investigator, Instituto Valenciano de Infertilidad, IVI Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02527954
- Sponsor's protocol ID
- 1412-ALC-086-PH
- Status last verified
- Mar 2019
- First submitted
- 11 Aug 2015
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferlin A, Arredi B, Speltra E, Cazzadore C, Selice R, Garolla A, Lenzi A, Foresta C. Molecular and clinical characterization of Y chromosome microdeletions in infertile men: a 10-year experience in Italy. J Clin Endocrinol Metab. 2007 Mar;92(3):762-70. doi: 10.1210/jc.2006-1981. Epub 2007 Jan 9.
PubMed 17213277Foresta C, Moro E, Ferlin A. Y chromosome microdeletions and alterations of spermatogenesis. Endocr Rev. 2001 Apr;22(2):226-39. doi: 10.1210/edrv.22.2.0425.
PubMed 11294825Foresta C, Moro E, Ferlin A. Prognostic value of Y deletion analysis. The role of current methods. Hum Reprod. 2001 Aug;16(8):1543-7. doi: 10.1093/humrep/16.8.1543.
PubMed 11473940Li Z, Haines CJ, Han Y. "Micro-deletions" of the human Y chromosome and their relationship with male infertility. J Genet Genomics. 2008 Apr;35(4):193-9. doi: 10.1016/S1673-8527(08)60027-2.
PubMed 18439975Sadeghi-Nejad H, Farrokhi F. Genetics of azoospermia: current knowledge, clinical implications, and future directions. Part II: Y chromosome microdeletions. Urol J. 2007 Fall;4(4):192-206.
PubMed 18270942Silber SJ. The Y chromosome in the era of intracytoplasmic sperm injection: a personal review. Fertil Steril. 2011 Jun 30;95(8):2439-48.e1-5. doi: 10.1016/j.fertnstert.2011.05.070.
PubMed 21704208Suganthi R, Vijesh VV, Vandana N, Fathima Ali Benazir J. Y choromosomal microdeletion screening in the workup of male infertility and its current status in India. Int J Fertil Steril. 2014 Jan;7(4):253-66. Epub 2013 Dec 22.
PubMed 24520494Choi JM, Chung P, Veeck L, Mielnik A, Palermo GD, Schlegel PN. AZF microdeletions of the Y chromosome and in vitro fertilization outcome. Fertil Steril. 2004 Feb;81(2):337-41. doi: 10.1016/j.fertnstert.2003.06.030.
PubMed 14967370Kihaile PE, Kisanga RE, Aoki K, Kumasako Y, Misumi J, Utsunomiya T. Embryo outcome in Y-chromosome microdeleted infertile males after ICSI. Mol Reprod Dev. 2004 Jun;68(2):176-81. doi: 10.1002/mrd.20074.
PubMed 15095338Liu XH, Qiao J, Li R, Yan LY, Chen LX. Y chromosome AZFc microdeletion may not affect the outcomes of ICSI for infertile males with fresh ejaculated sperm. J Assist Reprod Genet. 2013 Jun;30(6):813-9. doi: 10.1007/s10815-013-0009-y. Epub 2013 May 30.
PubMed 23715876Mulhall JP, Reijo R, Alagappan R, Brown L, Page D, Carson R, Oates RD. Azoospermic men with deletion of the DAZ gene cluster are capable of completing spermatogenesis: fertilization, normal embryonic development and pregnancy occur when retrieved testicular spermatozoa are used for intracytoplasmic sperm injection. Hum Reprod. 1997 Mar;12(3):503-8. doi: 10.1093/humrep/12.3.503.
PubMed 9130751Oates RD, Silber S, Brown LG, Page DC. Clinical characterization of 42 oligospermic or azoospermic men with microdeletion of the AZFc region of the Y chromosome, and of 18 children conceived via ICSI. Hum Reprod. 2002 Nov;17(11):2813-24. doi: 10.1093/humrep/17.11.2813.
PubMed 12407032Patrat C, Bienvenu T, Janny L, Faure AK, Fauque P, Aknin-Seifer I, Davy C, Thiounn N, Jouannet P, Levy R. Clinical data and parenthood of 63 infertile and Y-microdeleted men. Fertil Steril. 2010 Feb;93(3):822-32. doi: 10.1016/j.fertnstert.2008.10.033. Epub 2008 Dec 4.
PubMed 19062004Stouffs K, Lissens W, Tournaye H, Van Steirteghem A, Liebaers I. The choice and outcome of the fertility treatment of 38 couples in whom the male partner has a Yq microdeletion. Hum Reprod. 2005 Jul;20(7):1887-96. doi: 10.1093/humrep/deh847. Epub 2005 Mar 24.
PubMed 15790609van Golde RJ, Wetzels AM, de Graaf R, Tuerlings JH, Braat DD, Kremer JA. Decreased fertilization rate and embryo quality after ICSI in oligozoospermic men with microdeletions in the azoospermia factor c region of the Y chromosome. Hum Reprod. 2001 Feb;16(2):289-92. doi: 10.1093/humrep/16.2.289.
PubMed 11157822
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Y-chromosome Microdeletions From Infertile Men on the Chromosomal Constitution of Their Spermatozoa and Embryos. Combined IntraCytoplasmatic Sperm Injection (ICSI) and Preimplantation Genetic Screening (PGS) as Treatment Strategy.
- ClinicalTrials.gov ID
- NCT02527954
- Acronym / sponsor ID
- 1412-ALC-086-PH
- Keywords
- Y-chromosome microdeletions, aneuploidy, embryos, spermatozoa
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI AlicanteUniversity, hospital or other
- Collaborators
- IVI Murcia, Igenomix
- Study start
- 22 Sep 2015
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 11 Jun 2018 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted reproduction in their clinics.
Detailed description
Nowadays, Y-chromosome microdeletions are one of the most common causes of male infertility. With a frequency of 8-20% in non-obstructive azoospermic men and 3-14% in severe oligozoospermic men, is the most usual chromosome anomaly associated with failure in sperm production, although the frequency seems to change due to differences in the experimental designs, the ethnic differences, the genetic background, or even environmental influences.
The absence of some genes located on certain regions in the long arm of the human Y chromosome, known as the azoospermia factor region (AZF), causes spermatogenic failure, while spermatozoa has been found in either the ejaculate or the testicle of most patients. Detection of deletions is crucial for the medical treatment of these patients, since it has a prognostic value in predicting potential success of testicular sperm retrieval in azoospermic patients with certain microdeletions, and allows avoiding invasive techniques in oligozoospermic patients whose sperm production could result in progressive worsening.
The development of assisted reproduction techniques, such as intracytoplasmatic sperm injection (ICSI), together with testicular or epididymis sperm retrieval for azoospermic men has allowed these patients to become fathers using their own gametes. Although the effect of Y-chromosome microdeletions on ICSI outcome is controversial, the ability to vertically transmit that genetic defect, and so the infertility, to the offspring has been accepted. Until recently, no clinical consequences other than infertility were supposed in the ICSI-conceived sons of fathers with deletions. However, different studies in the last years, suggest other potentially risks transmitted to the offspring, such as the development of sexual dysfunction due to sex chromosome abnormalities (Turner or Klinefelter syndromes, etc.) or other somatic disorders with worse health implications caused by chromosome aberrations outside the AZF regions or in autosomes that has been associated to Y-chromosome microdeletions. No major clinical complications than infertility has been described in the offspring born from fathers with deletions to date, but it is important to remember that the first generation of those babies, mainly obtained by ICSI, has just reached maturity. Moreover, the mentioned chromosome anomalies, could stop embryo development or increase miscarriage rate. Few studies focused in the incidence of miscarriages in these couples but microdeletions have been detected more frequents in men from couples with recurrent pregnancy loss.
In order to offer fully genetic counseling to these couples, further studies focusing on the relationship between Y-chromosome microdeletions and other chromosomal abnormalities, which also provide information about their consequences in their embryos, are required. Thus, the actual risk of transmitting different anomalies associated to microdeletions to those embryos will be clarified, increasing the chances of a successful pregnancy and live birth.
In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted reproduction in their clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infertile with Y-chromosome deletions | – | –No intervention will be performed. Couples whose infertile men has a Y-chromosome microdeletion (detected in blood cells by Polymerase chain reaction multiplex) and fulfill the criteria will be included in this group (group 1) |
| Infertile without Y-chromosome deletions | – | –No intervention will be performed. Couples whose infertile men has not any Y-chromosome microdeletion (detected in blood cells by polymerase chain reaction multiplex) and fulfill the criteria will be included in this group (group 2) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples undergoing "In vitro" Fertilization (IVF) treatment whose man has non-obstructive azoospermia or severe oligozoospermia (≤ 5x1000000 spermatozoa/ml) and consent the genetic analysis of semen samples, as well as the embryo cohort generated by ICSI.
Key inclusion criteria (5 listed)
- Couples with male infertility whose man has non-obstructive azoospermia or severe oligozoospermia with ≤5x1000000 spermatozoa/ml.
- Assisted Reproductive Technology: ICSI with motile spermatozoa and PGS by CGH arrays.
- Women <38 years if microinjection is carried out in their own eggs, or 38≤ age <50 years if they receive donated eggs.
- Women with body mass index (BMI)<30.
- Men<50 years
Key exclusion criteria (5 listed)
- Couples with abnormal karyotypes.
- Women with any uterine pathology or abnormality, hydrosalpinx, thrombophilia or systemic diseases at the time of embryo transfer that could prejudge the outcome of the cycle
- Couples with repeated miscarriages (≥2) or implantation failures (≥2).
- Couples whose men has obstructive azoospermia, genital tract infections (mumps, inflammation, varicocele), cryptorchidism, or if he receives any treatment that can reduce the sperm count.
- Seminal samples processed by Magnetic Activated Cell Sorting (MACS) technique.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% Embryos with aneuploidies
Time frame: three years
The incidence of embryonic aneuploidies will be examined by CGH arrays analysis after biopsy in day 3 or day 5 of embryo development. This technology allows the analysis of all the chromosomes, so both aneuploidies in gonosomes and autosomes will be determined. To measure these percentages the images obtained after CGH array will be analyzed by BlueFuse Software (BlueGnome, Cambridge, UK), identifying normal euploid embryos, embryos with full or partial aneuploidy and chaotic embryos.
12 secondary outcomes
% Spermatozoa with aneuploidies
Time frame: Three years
Fertilization rate (%)
Time frame: three years
Day 3 embryos rate (%)
Time frame: Three years
Blastocyst rate (%)
Time frame: Three years
Cycle efficiency
Time frame: Four years
Pregnancy rate (%)
Time frame: Four years
Biochemical pregnancy rate (%)
Time frame: Four years
Clinical pregnancy rate (%)
Time frame: Four years
Implantation rate (%)
Time frame: Four years
Abortion rate (%)
Time frame: Four years
Ongoing pregnancy rate (%)
Time frame: Four years
Live birth rate (%)
Time frame: Four years
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Background: PubMed 17213277Ferlin A, Arredi B, Speltra E, Cazzadore C, Selice R, Garolla A, Lenzi A, Foresta C. Molecular and clinical characterization of Y chromosome microdeletions in infertile men: a 10-year experience in Italy. J Clin Endocrinol Metab. 2007 Mar;92(3):762-70. doi: 10.1210/jc.2006-1981. Epub 2007 Jan 9.
- Background: PubMed 11294825Foresta C, Moro E, Ferlin A. Y chromosome microdeletions and alterations of spermatogenesis. Endocr Rev. 2001 Apr;22(2):226-39. doi: 10.1210/edrv.22.2.0425.
- Background: PubMed 11473940Foresta C, Moro E, Ferlin A. Prognostic value of Y deletion analysis. The role of current methods. Hum Reprod. 2001 Aug;16(8):1543-7. doi: 10.1093/humrep/16.8.1543.
- Background: PubMed 18439975Li Z, Haines CJ, Han Y. "Micro-deletions" of the human Y chromosome and their relationship with male infertility. J Genet Genomics. 2008 Apr;35(4):193-9. doi: 10.1016/S1673-8527(08)60027-2.
- Background: PubMed 18270942Sadeghi-Nejad H, Farrokhi F. Genetics of azoospermia: current knowledge, clinical implications, and future directions. Part II: Y chromosome microdeletions. Urol J. 2007 Fall;4(4):192-206.
- Background: PubMed 21704208Silber SJ. The Y chromosome in the era of intracytoplasmic sperm injection: a personal review. Fertil Steril. 2011 Jun 30;95(8):2439-48.e1-5. doi: 10.1016/j.fertnstert.2011.05.070.
- Background: PubMed 24520494Suganthi R, Vijesh VV, Vandana N, Fathima Ali Benazir J. Y choromosomal microdeletion screening in the workup of male infertility and its current status in India. Int J Fertil Steril. 2014 Jan;7(4):253-66. Epub 2013 Dec 22.
- Background: PubMed 14967370Choi JM, Chung P, Veeck L, Mielnik A, Palermo GD, Schlegel PN. AZF microdeletions of the Y chromosome and in vitro fertilization outcome. Fertil Steril. 2004 Feb;81(2):337-41. doi: 10.1016/j.fertnstert.2003.06.030.
- Background: PubMed 15095338Kihaile PE, Kisanga RE, Aoki K, Kumasako Y, Misumi J, Utsunomiya T. Embryo outcome in Y-chromosome microdeleted infertile males after ICSI. Mol Reprod Dev. 2004 Jun;68(2):176-81. doi: 10.1002/mrd.20074.
- Background: PubMed 23715876Liu XH, Qiao J, Li R, Yan LY, Chen LX. Y chromosome AZFc microdeletion may not affect the outcomes of ICSI for infertile males with fresh ejaculated sperm. J Assist Reprod Genet. 2013 Jun;30(6):813-9. doi: 10.1007/s10815-013-0009-y. Epub 2013 May 30.
- Background: PubMed 9130751Mulhall JP, Reijo R, Alagappan R, Brown L, Page D, Carson R, Oates RD. Azoospermic men with deletion of the DAZ gene cluster are capable of completing spermatogenesis: fertilization, normal embryonic development and pregnancy occur when retrieved testicular spermatozoa are used for intracytoplasmic sperm injection. Hum Reprod. 1997 Mar;12(3):503-8. doi: 10.1093/humrep/12.3.503.
- Background: PubMed 12407032Oates RD, Silber S, Brown LG, Page DC. Clinical characterization of 42 oligospermic or azoospermic men with microdeletion of the AZFc region of the Y chromosome, and of 18 children conceived via ICSI. Hum Reprod. 2002 Nov;17(11):2813-24. doi: 10.1093/humrep/17.11.2813.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Purificación Hernández-Vargas, PhD principal investigator
Instituto Valenciano de Infertilidad, IVI Alicante
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Sterility Due to Y-chromosome Deletions, run by Instituto Valenciano de Infertilidad, IVI Alicante at 3 sites in Spain.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
% Embryos with aneuploidies (time frame: three years). 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 NCT02527954, which also lists 27 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 8 Mar 2019.