PregnancyNCT03095053
PGT-A Versus Blastocyst Morphology Selection
A study testing comprehensive chromosome screening in people with Pregnancy, run by Antalya IVF at 1 site in Turkey (Türkiye).
Trial summary
Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- comprehensive chromosome screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2017to 21 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient-couples eligible for inclusion in the trial must satisfy the following criteria; female age of ≤35 years, female body mass index (BMI) of ≥18 or ≤35 kg/m2, antral follicle count (AFC) of ≥10, normo-ovulatory, intend to use autologous oocytes, and have ≥2 blastocysts with a morphological score of 2BB on day 5 of embryo development
Who cannot join
- Patient couples will be excluded from the trial for the following reasons, patients with drug contraindications, patients with pathophysiology unrelated to reproduction, patients with intrauterine pathophysiologies, patients with no blastocysts, patients with <2 blastocysts with a morphological score of 2BB.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PGT for Aneuploidy Does Not Enhance Live Birth in Young Patients (≤35 Years): a Randomized Controlled Trial of Single Blastocyst Frozen Embryo Transfers (ClinicalTrials.Gov ID: NCT03095053)
Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly over the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in increased numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes of IVF, they still remain suboptimal. The main objective of this randomized controlled trial (RCT) will be to investigate whether preimplantation genetic testing (i.e., PGT with comprehensive chromosome screening (CCS)) for aneuploidy is a superior embryo selection method, with the live birth outcomes of euploid blastocyst frozen embryo transfers (FET) compared with the LB outcomes of unknown-ploidy blastocyst FET, with blastocysts selected on (standard) morphological score.
Methods This RCT will be conducted at a single private IVF centre performing routine segmented-IVF, with intracytoplasmic sperm injection (ICSI), blastocyst freeze-all, and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with maternal age ≤35 years and at least two blastocysts with a morphology score of 2BB cryopreserved, will be randomized by computer-generated randomized allocation to either the PGT or morphology arm of the trial. All transfers will be single embryo transfers (SET), with only the first FET cycles following freeze-all to be analyzed.
Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has approved the trial (reference number: 2015/399), with anonymized results to be released in ClinicalTrials.gov. All patients will provide informed consent, which included an agreement for the use of anonymised data for research and SET.
Read the detailed description
Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Embryo morphology assessment methods have significant limitations (i.e., the assessments are subjective and the method uses fixed time-point assessments to define dynamic embryo development) and shortcomings (i.e., exposes embryos to sub-optimal conditions during assessment). Notwithstanding the limitations and shortcomings of this method its use worldwide has continued, because it is a relatively simple and non-invasive method and its scores have been shown to be (moderately) positively correlated to embryo euploidy, ongoing pregnancy, and live birth (Van Royen et al., 1999, Ahlstrom et al., 2011, Forman et al., 2013, Capalbo et al., 2014, Oron et al., 2014, Rhenman et al., 2015).
However multiple gestations still represents one of the most significant complications in IVF, which are mainly the result of multiple-embryo embryo transfers, with multiple-embryo transfers used to overcome the relatively low embryo implantation rates in IVF. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly in the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in the numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes in IVF, the use of SET and PGT technologies have revealed embryo implantation still to be sub-optimal (Schoolcraft et al., 2013). New CCS platforms are a major breakthrough in PGT, allowing 24-chromosome screening to be performed with high degree of accuracy from single cells (Harper and Harton, 2010). The evidence that morphology scores were only moderately associated with euploidy and that the transfer of PGT predicted euploid embryos resulted in higher implantation rates (Dahdouh et al., 2015), has seen the continued use of morphology-based scoring methods increasingly being challenged.
In addition to all the other advances in IVF, significant improvements have also been made in cryopreservation technologies. These improvements have resulted in significant improvements in frozen-thawed embryo survival (i.e. minimizing of risks), post-thaw developmental competence (Cobo et al., 2012; Balaban et al., 2008), and in the reproductive outcomes of FET (Evans et al., 2014; Ozgur et al., 2015). The benefits of FET include; the transfer of embryos to a more physiologic endometrium (i.e., early luteal phase), the ability to time transfers more accurately, and the ability to use patient-specific endometrial preparations (Casper and Yanushpolsky, 2016, Franasiak et al., 2016; Groenewoud et al., 2013, Yarali et al., 2016).
Moreover, the hypotheses of PGT requires to be confirmed in further robust RCT before its implementation in routine IVF.
Objectives The primary objective of this RCT will be to investigate whether PGT for aneuploidy as a blastocyst selection method is superior to standard morphology scoring blastocyst selection, comparing the reproductive outcomes in FET cycles. The decision to transfer all blastocysts in FET will eliminate any potential impact of ovarian stimulation confounding on endometrial receptivity and to use freeze-all cycles will allow the use of the primary blastocysts of blastocyst cohorts. The primary outcome measure of this trial will be LB, with a LB defined as a pregnancy cycle delivering at >20 weeks of gestation.
Secondary objectives The secondary objective of the RCT will be to investigate whether euploid blastocyst transfer results in reduced miscarriage, with a miscarriage defined as a clinical pregnancy lost at <20 weeks of gestation.
Keywords: blastocyst; comprehensive chromosome screening; euploidy; frozen embryo transfer
- Conditions
- Pregnancy
- Being tested
- comprehensive chromosome screening
- Keywords
- morphological score, preimplantation genetic testing, frozen embryo transfer, blastocyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive chromosome screeningProcedure or surgery
Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.
Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA).
| Study group | Role | What they receive |
|---|---|---|
| PGT-A group | Active comparator | Next Generation sequencing preimplantation genetic testing for aneuploidy Receives: Procedure: comprehensive chromosome screening |
| Morphology group | No intervention | morphological assessment of blastocyst by light microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With a Live Birth
A live birth cycle was defined as a cycle with a delivery after 20 weeks of gestation.
Measured: >20 weeks gestation
Secondary outcomes (2)
The Percentage of Patients With a Clinical Pregnancy
A clinical pregnancy was defined as a cycle with a fetal sac observed on ultrasound after 5 weeks of gestation
Measured: >5 weeks of gestation
The Percentage of Pregnancies That Miscarried
A miscarriage was defined as the loss of a clinical pregnancy before 20 weeks of gestation.
Measured: <20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start23 Mar 2017
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-centre randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Coetzee, Antalya IVF
- Investigators
- Kevin Coetzee, PhD, Principal investigator, Antalya IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095053
- Sponsor's protocol ID
- euploid versus morphology
- Other IDs
- Optimizing implantation in FET
- Status last verified
- Mar 2019
- First submitted
- 23 Mar 2017
- Last updated
- 17 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ahlstrom A, Westin C, Reismer E, Wikland M, Hardarson T. Trophectoderm morphology: an important parameter for predicting live birth after single blastocyst transfer. Hum Reprod. 2011 Dec;26(12):3289-96. doi: 10.1093/humrep/der325. Epub 2011 Oct 3.
PubMed 21972253Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.
PubMed 18544577Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26.
PubMed 24578475Casper RF, Yanushpolsky EH. Optimal endometrial preparation for frozen embryo transfer cycles: window of implantation and progesterone support. Fertil Steril. 2016 Apr;105(4):867-72. doi: 10.1016/j.fertnstert.2016.01.006. Epub 2016 Jan 25.
PubMed 26820769Cobo A, de los Santos MJ, Castello D, Gamiz P, Campos P, Remohi J. Outcomes of vitrified early cleavage-stage and blastocyst-stage embryos in a cryopreservation program: evaluation of 3,150 warming cycles. Fertil Steril. 2012 Nov;98(5):1138-46.e1. doi: 10.1016/j.fertnstert.2012.07.1107. Epub 2012 Aug 3.
PubMed 22862909Dahdouh EM, Balayla J, Garcia-Velasco JA. Comprehensive chromosome screening improves embryo selection: a meta-analysis. Fertil Steril. 2015 Dec;104(6):1503-12. doi: 10.1016/j.fertnstert.2015.08.038. Epub 2015 Sep 16.
PubMed 26385405Evans J, Hannan NJ, Edgell TA, Vollenhoven BJ, Lutjen PJ, Osianlis T, Salamonsen LA, Rombauts LJ. Fresh versus frozen embryo transfer: backing clinical decisions with scientific and clinical evidence. Hum Reprod Update. 2014 Nov-Dec;20(6):808-21. doi: 10.1093/humupd/dmu027. Epub 2014 Jun 10.
PubMed 24916455Forman EJ, Upham KM, Cheng M, Zhao T, Hong KH, Treff NR, Scott RT Jr. Comprehensive chromosome screening alters traditional morphology-based embryo selection: a prospective study of 100 consecutive cycles of planned fresh euploid blastocyst transfer. Fertil Steril. 2013 Sep;100(3):718-24. doi: 10.1016/j.fertnstert.2013.04.043. Epub 2013 May 30.
PubMed 23725804Franasiak JM, Ruiz-Alonso M, Scott RT, Simon C. Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo. Fertil Steril. 2016 Apr;105(4):861-6. doi: 10.1016/j.fertnstert.2016.02.030.
PubMed 26940791Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
PubMed 23820515Harper JC, Harton G. The use of arrays in preimplantation genetic diagnosis and screening. Fertil Steril. 2010 Sep;94(4):1173-1177. doi: 10.1016/j.fertnstert.2010.04.064. Epub 2010 Jun 25.
PubMed 20579641Oron G, Son WY, Buckett W, Tulandi T, Holzer H. The association between embryo quality and perinatal outcome of singletons born after single embryo transfers: a pilot study. Hum Reprod. 2014 Jul;29(7):1444-51. doi: 10.1093/humrep/deu079. Epub 2014 May 8.
PubMed 24812313Ozgur K, Berkkanoglu M, Bulut H, Isikli A, Coetzee K. Higher clinical pregnancy rates from frozen-thawed blastocyst transfers compared to fresh blastocyst transfers: a retrospective matched-cohort study. J Assist Reprod Genet. 2015 Oct;32(10):1483-90. doi: 10.1007/s10815-015-0576-1. Epub 2015 Sep 23.
PubMed 26400506Rhenman A, Berglund L, Brodin T, Olovsson M, Milton K, Hadziosmanovic N, Holte J. Which set of embryo variables is most predictive for live birth? A prospective study in 6252 single embryo transfers to construct an embryo score for the ranking and selection of embryos. Hum Reprod. 2015 Jan;30(1):28-36. doi: 10.1093/humrep/deu295. Epub 2014 Nov 5.
PubMed 25376459Schoolcraft WB, Katz-Jaffe MG. Comprehensive chromosome screening of trophectoderm with vitrification facilitates elective single-embryo transfer for infertile women with advanced maternal age. Fertil Steril. 2013 Sep;100(3):615-9. doi: 10.1016/j.fertnstert.2013.07.1972.
PubMed 23993664
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PGT for Aneuploidy Does Not Enhance Live Birth in Young Patients (≤35 Years): a Randomized Controlled Trial of Single Blastocyst Frozen Embryo Transfers (ClinicalTrials.Gov ID: NCT03095053)
- ClinicalTrials.gov ID
- NCT03095053
- Acronym / sponsor ID
- euploid versus morphology
- Conditions
- Pregnancy
- Keywords
- morphological score, preimplantation genetic testing, frozen embryo transfer, blastocyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Antalya IVFUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Posted 17 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly over the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in increased numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes of IVF, they still remain suboptimal. The main objective of this randomized controlled trial (RCT) will be to investigate whether preimplantation genetic testing (i.e., PGT with comprehensive chromosome screening (CCS)) for aneuploidy is a superior embryo selection method, with the live birth outcomes of euploid blastocyst frozen embryo transfers (FET) compared with the LB outcomes of unknown-ploidy blastocyst FET, with blastocysts selected on (standard) morphological score.
Methods This RCT will be conducted at a single private IVF centre performing routine segmented-IVF, with intracytoplasmic sperm injection (ICSI), blastocyst freeze-all, and artificial frozen embryo transfer (art-FET). Normo-ovulatory infertile patients, with maternal age ≤35 years and at least two blastocysts with a morphology score of 2BB cryopreserved, will be randomized by computer-generated randomized allocation to either the PGT or morphology arm of the trial. All transfers will be single embryo transfers (SET), with only the first FET cycles following freeze-all to be analyzed.
Consent and Ethics Akdeniz University Medical Faculty Clinical Research Ethics Committee has approved the trial (reference number: 2015/399), with anonymized results to be released in ClinicalTrials.gov. All patients will provide informed consent, which included an agreement for the use of anonymised data for research and SET.
Detailed description
Introduction Embryo aneuploidy is likely the leading cause of implantation failure in IVF cycles. Since the inception of IVF, non-invasive morphology based scoring has been the most widely used embryo selection method, resulting in relatively low embryo implantation rates. Embryo morphology assessment methods have significant limitations (i.e., the assessments are subjective and the method uses fixed time-point assessments to define dynamic embryo development) and shortcomings (i.e., exposes embryos to sub-optimal conditions during assessment). Notwithstanding the limitations and shortcomings of this method its use worldwide has continued, because it is a relatively simple and non-invasive method and its scores have been shown to be (moderately) positively correlated to embryo euploidy, ongoing pregnancy, and live birth (Van Royen et al., 1999, Ahlstrom et al., 2011, Forman et al., 2013, Capalbo et al., 2014, Oron et al., 2014, Rhenman et al., 2015).
However multiple gestations still represents one of the most significant complications in IVF, which are mainly the result of multiple-embryo embryo transfers, with multiple-embryo transfers used to overcome the relatively low embryo implantation rates in IVF. Our understanding of the optimal conditions required for in vitro embryo culture in IVF has advanced significantly in the past two decades. The implementation of improved in vitro embryo culture technologies (i.e., culture media and incubators) has resulted in an increase in the number of good quality embryos and consequently in the numbers of blastocysts. While blastocyst transfers have seemingly improved the reproductive outcomes in IVF, the use of SET and PGT technologies have revealed embryo implantation still to be sub-optimal (Schoolcraft et al., 2013). New CCS platforms are a major breakthrough in PGT, allowing 24-chromosome screening to be performed with high degree of accuracy from single cells (Harper and Harton, 2010). The evidence that morphology scores were only moderately associated with euploidy and that the transfer of PGT predicted euploid embryos resulted in higher implantation rates (Dahdouh et al., 2015), has seen the continued use of morphology-based scoring methods increasingly being challenged.
In addition to all the other advances in IVF, significant improvements have also been made in cryopreservation technologies. These improvements have resulted in significant improvements in frozen-thawed embryo survival (i.e. minimizing of risks), post-thaw developmental competence (Cobo et al., 2012; Balaban et al., 2008), and in the reproductive outcomes of FET (Evans et al., 2014; Ozgur et al., 2015). The benefits of FET include; the transfer of embryos to a more physiologic endometrium (i.e., early luteal phase), the ability to time transfers more accurately, and the ability to use patient-specific endometrial preparations (Casper and Yanushpolsky, 2016, Franasiak et al., 2016; Groenewoud et al., 2013, Yarali et al., 2016).
Moreover, the hypotheses of PGT requires to be confirmed in further robust RCT before its implementation in routine IVF.
Objectives The primary objective of this RCT will be to investigate whether PGT for aneuploidy as a blastocyst selection method is superior to standard morphology scoring blastocyst selection, comparing the reproductive outcomes in FET cycles. The decision to transfer all blastocysts in FET will eliminate any potential impact of ovarian stimulation confounding on endometrial receptivity and to use freeze-all cycles will allow the use of the primary blastocysts of blastocyst cohorts. The primary outcome measure of this trial will be LB, with a LB defined as a pregnancy cycle delivering at >20 weeks of gestation.
Secondary objectives The secondary objective of the RCT will be to investigate whether euploid blastocyst transfer results in reduced miscarriage, with a miscarriage defined as a clinical pregnancy lost at <20 weeks of gestation.
Keywords: blastocyst; comprehensive chromosome screening; euploidy; frozen embryo transfer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-centre randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| PGT-A group | Active comparator | Procedure: comprehensive chromosome screeningNext Generation sequencing preimplantation genetic testing for aneuploidy |
| Morphology group | No intervention | –morphological assessment of blastocyst by light microscope |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient-couples eligible for inclusion in the trial must satisfy the following criteria; female age of ≤35 years, female body mass index (BMI) of ≥18 or ≤35 kg/m2, antral follicle count (AFC) of ≥10, normo-ovulatory, intend to use autologous oocytes, and have ≥2 blastocysts with a morphological score of 2BB on day 5 of embryo development
Key exclusion criteria (1 listed)
- Patient couples will be excluded from the trial for the following reasons, patients with drug contraindications, patients with pathophysiology unrelated to reproduction, patients with intrauterine pathophysiologies, patients with no blastocysts, patients with <2 blastocysts with a morphological score of 2BB.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive chromosome screeningBiopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts. Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA). | Procedure or surgery | PGT-A group |
Primary outcome
The Percentage of Patients With a Live Birth
Time frame: >20 weeks gestation
A live birth cycle was defined as a cycle with a delivery after 20 weeks of gestation.
2 secondary outcomes
The Percentage of Patients With a Clinical Pregnancy
Time frame: >5 weeks of gestation
The Percentage of Pregnancies That Miscarried
Time frame: <20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21972253Ahlstrom A, Westin C, Reismer E, Wikland M, Hardarson T. Trophectoderm morphology: an important parameter for predicting live birth after single blastocyst transfer. Hum Reprod. 2011 Dec;26(12):3289-96. doi: 10.1093/humrep/der325. Epub 2011 Oct 3.
- Results publication: PubMed 18544577Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.
- Results publication: PubMed 24578475Capalbo A, Rienzi L, Cimadomo D, Maggiulli R, Elliott T, Wright G, Nagy ZP, Ubaldi FM. Correlation between standard blastocyst morphology, euploidy and implantation: an observational study in two centers involving 956 screened blastocysts. Hum Reprod. 2014 Jun;29(6):1173-81. doi: 10.1093/humrep/deu033. Epub 2014 Feb 26.
- Results publication: PubMed 26820769Casper RF, Yanushpolsky EH. Optimal endometrial preparation for frozen embryo transfer cycles: window of implantation and progesterone support. Fertil Steril. 2016 Apr;105(4):867-72. doi: 10.1016/j.fertnstert.2016.01.006. Epub 2016 Jan 25.
- Results publication: PubMed 22862909Cobo A, de los Santos MJ, Castello D, Gamiz P, Campos P, Remohi J. Outcomes of vitrified early cleavage-stage and blastocyst-stage embryos in a cryopreservation program: evaluation of 3,150 warming cycles. Fertil Steril. 2012 Nov;98(5):1138-46.e1. doi: 10.1016/j.fertnstert.2012.07.1107. Epub 2012 Aug 3.
- Results publication: PubMed 26385405Dahdouh EM, Balayla J, Garcia-Velasco JA. Comprehensive chromosome screening improves embryo selection: a meta-analysis. Fertil Steril. 2015 Dec;104(6):1503-12. doi: 10.1016/j.fertnstert.2015.08.038. Epub 2015 Sep 16.
- Results publication: PubMed 24916455Evans J, Hannan NJ, Edgell TA, Vollenhoven BJ, Lutjen PJ, Osianlis T, Salamonsen LA, Rombauts LJ. Fresh versus frozen embryo transfer: backing clinical decisions with scientific and clinical evidence. Hum Reprod Update. 2014 Nov-Dec;20(6):808-21. doi: 10.1093/humupd/dmu027. Epub 2014 Jun 10.
- Results publication: PubMed 23725804Forman EJ, Upham KM, Cheng M, Zhao T, Hong KH, Treff NR, Scott RT Jr. Comprehensive chromosome screening alters traditional morphology-based embryo selection: a prospective study of 100 consecutive cycles of planned fresh euploid blastocyst transfer. Fertil Steril. 2013 Sep;100(3):718-24. doi: 10.1016/j.fertnstert.2013.04.043. Epub 2013 May 30.
- Results publication: PubMed 26940791Franasiak JM, Ruiz-Alonso M, Scott RT, Simon C. Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo. Fertil Steril. 2016 Apr;105(4):861-6. doi: 10.1016/j.fertnstert.2016.02.030.
- Results publication: PubMed 23820515Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
- Results publication: PubMed 20579641Harper JC, Harton G. The use of arrays in preimplantation genetic diagnosis and screening. Fertil Steril. 2010 Sep;94(4):1173-1177. doi: 10.1016/j.fertnstert.2010.04.064. Epub 2010 Jun 25.
- Results publication: PubMed 24812313Oron G, Son WY, Buckett W, Tulandi T, Holzer H. The association between embryo quality and perinatal outcome of singletons born after single embryo transfers: a pilot study. Hum Reprod. 2014 Jul;29(7):1444-51. doi: 10.1093/humrep/deu079. Epub 2014 May 8.
- Individual participant dataSharing planned: No
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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.
Kevin Coetzee, PhD principal investigator
Antalya IVF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive chromosome screening in people with Pregnancy, run by Antalya IVF at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 17 Jun 2019. 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 Turkey (Türkiye). 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?
Yes. Results are posted in the registry (first posted 17 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Patients With a Live Birth (time frame: >20 weeks gestation). 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 NCT03095053, which also lists 18 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 17 Jun 2019.