InfertilityCESE-PGSNCT03118141
Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization
A study testing blastocyst morphologic score, blastocyst biopsy and sequencing and freeze-all and single thawed blastocyst transfer in people with Infertility, run by Chen Zi-Jiang at 1 site in China.
Trial summary
The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- blastocyst morphologic score, blastocyst biopsy and sequencing and freeze-all and single thawed blastocyst transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,215 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2017to Jun 2020
- Phase
- Interventional
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who are participating in their first cycle of IVF or ICSI
- Women ages 20 to 37 years.
- Women who obtain 3 or more good-quality blastocysts defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on day 5 of embryo culture will be randomized.
Who cannot join
- Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s); or with history of intrauterine adhesions.
- Women with untreated hydrosalpinx;
- Women who are indicated and planned to undergo PGD, for example, parental abnormal karyo-type or diagnosed with monogenic disease;
- Women who use donated oocytes or sperm to achieve pregnancy;
- Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong University
Jinan, Shandong
Zi-Jiang Chen, Professor, +0086 531 85651190, chenzijiang@vip.163.com
About this study
Official title: Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial
The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.
Read the detailed description
This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.
- Conditions
- Infertility
- Being tested
- blastocyst morphologic score, blastocyst biopsy and sequencing, freeze-all and single thawed blastocyst transfer
- Keywords
- preimplantation genetic screening, single embryo transfer, frozen embryo transfer, cumulative live birth rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blastocyst morphologic scoreProcedure or surgery
Blastocysts will be scored by Gardner morphologic criteria.
blastocyst biopsy and sequencingProcedure or surgery
Three blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
freeze-all and single thawed blastocyst transferProcedure or surgery
All blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred.
| Study group | Role | What they receive |
|---|---|---|
| PGS group | Active comparator | Subjects in the PGS group will have blastocyst biopsy and sequencing done with 3 good-quality embryos on Day 5. Principle of freeze-all and single thawed blastocyst transfer will be applied. The transfer order of euploid embryos will be determined by blastocyst morphologic score. The outcome of all euploids transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth. Receives: Procedure: blastocyst morphologic score; Procedure: blastocyst biopsy and sequencing; Procedure: freeze-all and single thawed blastocyst transfer |
| IVF group | Active comparator | Subjects in the IVF group will also comply with the principle of freeze-all and single thawed blastocyst transfer. The order of transfer will be determined by blastocyst morphologic score. The outcome of up to 3 transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth. Receives: Procedure: blastocyst morphologic score; Procedure: freeze-all and single thawed blastocyst transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
Measured: 22 months
Secondary outcomes (8)
Rate of Good Birth Outcomes
Number of good birth outcomes / number of clinical pregnancies over (up to) 3 transfers within 1 year.Good Birth Outcome is defined as live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly.
Measured: 22 months
Cumulative pregnancy rate
Number of women with clinical pregnancies over (up to) 3 transfers within 1 year / number of women randomized to the specific group. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Measured: 14 months
Cumulative pregnancy loss rate
Number of pregnancy losses / number of clinical pregnancies over (up to) 3 transfers within 1 year.Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
Measured: 19 months
Multiple pregnancy rate
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Measured: 22 months
Duration of pregnancy
The time from the first day of last menstrual period to the day of delivery.
Measured: 22 months
Birth weight
Weight of newborns at delivery.
Measured: 22 months
Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage
Number of pregnancies with complications / number of pregnancies over (up to) 3 transfers within 1 year;number of live births with neonatal complications / number of live births over (up to)3 transfers within 1 year.
Measured: 22 months
Number of embryo transfers to achieve live birth
Number of embryo transfers the patients have gone through to achieve live birth.
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start9 Jul 2017
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies 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
- Masking
- None (open label)
- Enrolment
- 1,215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Zi-Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Peking University Third Hospital, ShangHai Ji Ai Genetics & IVF Institute, RenJi Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Suzhou Municipal Hospital, Renmin Hospital of Wuhan University, Yantai Yuhuangding Hospital, Tang-Du Hospital, Nanjing Maternity and Child Health Care Hospital, Guangxi Maternal and Child Health Hospital, Women's Hospital School Of Medicine Zhejiang University, Guangdong Women and Children Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Shengjing Hospital, The First Affiliated Hospital of Anhui Medical University
- Responsible party
- Sponsor-investigator, Chen Zi-Jiang, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03118141
- Sponsor's protocol ID
- CESE-PGS
- Acronym
- CESE-PGS
- Status last verified
- Sep 2019
- First submitted
- 27 Mar 2017
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dahdouh 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 26385405Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.
PubMed 23548942Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
PubMed 22551456Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
PubMed 23731996Murugappan G, Ohno MS, Lathi RB. Cost-effectiveness analysis of preimplantation genetic screening and in vitro fertilization versus expectant management in patients with unexplained recurrent pregnancy loss. Fertil Steril. 2015 May;103(5):1215-20. doi: 10.1016/j.fertnstert.2015.02.012. Epub 2015 Mar 13.
PubMed 25772770Mastenbroek S, Repping S. Preimplantation genetic screening: back to the future. Hum Reprod. 2014 Sep;29(9):1846-50. doi: 10.1093/humrep/deu163. Epub 2014 Jul 8.
PubMed 25006207Huang J, Yan L, Lu S, Zhao N, Xie XS, Qiao J. Validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of blastocysts. Fertil Steril. 2016 Jun;105(6):1532-6. doi: 10.1016/j.fertnstert.2016.01.040. Epub 2016 Feb 19.
PubMed 26902859Guo L, Li X, Guo A, Wang Y, Liang Y, Li Y, Xu X, Lv H. Comparative study on pregnancy complications: PGT-A vs. IVF-ET with gender-specific outcomes. Front Endocrinol (Lausanne). 2024 Nov 6;15:1453083. doi: 10.3389/fendo.2024.1453083. eCollection 2024.
PubMed 39574950Guo L, Guo A, Lan X, Tian S, Sun F, Su Y, Chen ZJ, Cao Y, Li Y. Oligoasthenospermia is correlated with increased preeclampsia incidence in subfertile couples undergoing in vitro fertilization and embryo transfer: a secondary analysis of a randomized clinical trial. F S Sci. 2024 Nov;5(4):386-394. doi: 10.1016/j.xfss.2024.08.003. Epub 2024 Aug 15.
PubMed 39153572Ni T, Zhou W, Liu Y, Cui W, Liu Y, Lu J, Zhang Q, Chen ZJ, Li Y, Yan J. Excessive Exogenous Gonadotropins and Genetic and Pregnancy Outcomes After Euploidy Embryo Transfer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244438. doi: 10.1001/jamanetworkopen.2024.4438.
PubMed 38564220Hu M, Liu M, Tian S, Guo L, Zang Z, Chen ZJ, Li Y. Comparative analysis of pregnancy outcomes in preimplantation genetic testing for aneuploidy and conventional in vitro fertilization and embryo transfer: a stratified examination on the basis of the quantity of oocytes and blastocysts from a multicenter randomized controlled trial. Fertil Steril. 2024 Jul;122(1):121-130. doi: 10.1016/j.fertnstert.2024.02.023. Epub 2024 Feb 15.
PubMed 38367687Yan J, Qin Y, Zhao H, Sun Y, Gong F, Li R, Sun X, Ling X, Li H, Hao C, Tan J, Yang J, Zhu Y, Liu F, Chen D, Wei D, Lu J, Ni T, Zhou W, Wu K, Gao Y, Shi Y, Lu Y, Zhang T, Wu W, Ma X, Ma H, Fu J, Zhang J, Meng Q, Zhang H, Legro RS, Chen ZJ. Live Birth with or without Preimplantation Genetic Testing for Aneuploidy. N Engl J Med. 2021 Nov 25;385(22):2047-2058. doi: 10.1056/NEJMoa2103613.
PubMed 34818479Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3.
PubMed 32898291
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03118141
- Acronym / sponsor ID
- CESE-PGS / CESE-PGS
- Conditions
- Infertility
- Keywords
- preimplantation genetic screening, single embryo transfer, frozen embryo transfer, cumulative live birth rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,215 participants (estimated)
- Lead sponsor
- Chen Zi-JiangUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, Peking University Third Hospital, ShangHai Ji Ai Genetics & IVF Institute, RenJi Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Suzhou Municipal Hospital, Renmin Hospital of Wuhan University, Yantai Yuhuangding Hospital, Tang-Du Hospital, Nanjing Maternity and Child Health Care Hospital, Guangxi Maternal and Child Health Hospital, Women's Hospital School Of Medicine Zhejiang University, Guangdong Women and Children Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Shengjing Hospital, The First Affiliated Hospital of Anhui Medical University
- Study start
- 9 Jul 2017 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Apr 2017 (actual)
- 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.
The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.
Detailed description
This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PGS group | Active comparator | Procedure: blastocyst morphologic score, Procedure: blastocyst biopsy and sequencing, Procedure: freeze-all and single thawed blastocyst transferSubjects in the PGS group will have blastocyst biopsy and sequencing done with 3 good-quality embryos on Day 5. Principle of freeze-all and single thawed blastocyst transfer will be applied. The transfer order of euploid embryos will be determined by blastocyst morphologic score. The outcome of all euploids transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth. |
| IVF group | Active comparator | Procedure: blastocyst morphologic score, Procedure: freeze-all and single thawed blastocyst transferSubjects in the IVF group will also comply with the principle of freeze-all and single thawed blastocyst transfer. The order of transfer will be determined by blastocyst morphologic score. The outcome of up to 3 transfers within 1 year after randomization will be followed up. During study, every subject will have at most one live birth. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women who are participating in their first cycle of IVF or ICSI
- Women ages 20 to 37 years.
- Women who obtain 3 or more good-quality blastocysts defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on day 5 of embryo culture will be randomized.
Key exclusion criteria (5 listed)
- Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s); or with history of intrauterine adhesions.
- Women with untreated hydrosalpinx;
- Women who are indicated and planned to undergo PGD, for example, parental abnormal karyo-type or diagnosed with monogenic disease;
- Women who use donated oocytes or sperm to achieve pregnancy;
- Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.
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 |
|---|---|---|
| blastocyst morphologic scoreBlastocysts will be scored by Gardner morphologic criteria. | Procedure or surgery | IVF group, PGS group |
| blastocyst biopsy and sequencingThree blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score. | Procedure or surgery | PGS group |
| freeze-all and single thawed blastocyst transferAll blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred. | Procedure or surgery | IVF group, PGS group |
Primary outcome
Cumulative live birth rate
Time frame: 22 months
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.
8 secondary outcomes
Rate of Good Birth Outcomes
Time frame: 22 months
Cumulative pregnancy rate
Time frame: 14 months
Cumulative pregnancy loss rate
Time frame: 19 months
Multiple pregnancy rate
Time frame: 22 months
Duration of pregnancy
Time frame: 22 months
Birth weight
Time frame: 22 months
Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage
Time frame: 22 months
Number of embryo transfers to achieve live birth
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: 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.
- Background: PubMed 23548942Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.
- Background: PubMed 22551456Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients: results from a randomized pilot study. Mol Cytogenet. 2012 May 2;5(1):24. doi: 10.1186/1755-8166-5-24.
- Background: PubMed 23731996Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
- Background: PubMed 25772770Murugappan G, Ohno MS, Lathi RB. Cost-effectiveness analysis of preimplantation genetic screening and in vitro fertilization versus expectant management in patients with unexplained recurrent pregnancy loss. Fertil Steril. 2015 May;103(5):1215-20. doi: 10.1016/j.fertnstert.2015.02.012. Epub 2015 Mar 13.
- Background: PubMed 25006207Mastenbroek S, Repping S. Preimplantation genetic screening: back to the future. Hum Reprod. 2014 Sep;29(9):1846-50. doi: 10.1093/humrep/deu163. Epub 2014 Jul 8.
- Background: PubMed 26902859Huang J, Yan L, Lu S, Zhao N, Xie XS, Qiao J. Validation of a next-generation sequencing-based protocol for 24-chromosome aneuploidy screening of blastocysts. Fertil Steril. 2016 Jun;105(6):1532-6. doi: 10.1016/j.fertnstert.2016.01.040. Epub 2016 Feb 19.
- Derived from this study: PubMed 39574950Guo L, Li X, Guo A, Wang Y, Liang Y, Li Y, Xu X, Lv H. Comparative study on pregnancy complications: PGT-A vs. IVF-ET with gender-specific outcomes. Front Endocrinol (Lausanne). 2024 Nov 6;15:1453083. doi: 10.3389/fendo.2024.1453083. eCollection 2024.
- Derived from this study: PubMed 39153572Guo L, Guo A, Lan X, Tian S, Sun F, Su Y, Chen ZJ, Cao Y, Li Y. Oligoasthenospermia is correlated with increased preeclampsia incidence in subfertile couples undergoing in vitro fertilization and embryo transfer: a secondary analysis of a randomized clinical trial. F S Sci. 2024 Nov;5(4):386-394. doi: 10.1016/j.xfss.2024.08.003. Epub 2024 Aug 15.
- Derived from this study: PubMed 38564220Ni T, Zhou W, Liu Y, Cui W, Liu Y, Lu J, Zhang Q, Chen ZJ, Li Y, Yan J. Excessive Exogenous Gonadotropins and Genetic and Pregnancy Outcomes After Euploidy Embryo Transfer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e244438. doi: 10.1001/jamanetworkopen.2024.4438.
- Derived from this study: PubMed 38367687Hu M, Liu M, Tian S, Guo L, Zang Z, Chen ZJ, Li Y. Comparative analysis of pregnancy outcomes in preimplantation genetic testing for aneuploidy and conventional in vitro fertilization and embryo transfer: a stratified examination on the basis of the quantity of oocytes and blastocysts from a multicenter randomized controlled trial. Fertil Steril. 2024 Jul;122(1):121-130. doi: 10.1016/j.fertnstert.2024.02.023. Epub 2024 Feb 15.
- Derived from this study: PubMed 34818479Yan J, Qin Y, Zhao H, Sun Y, Gong F, Li R, Sun X, Ling X, Li H, Hao C, Tan J, Yang J, Zhu Y, Liu F, Chen D, Wei D, Lu J, Ni T, Zhou W, Wu K, Gao Y, Shi Y, Lu Y, Zhang T, Wu W, Ma X, Ma H, Fu J, Zhang J, Meng Q, Zhang H, Legro RS, Chen ZJ. Live Birth with or without Preimplantation Genetic Testing for Aneuploidy. N Engl J Med. 2021 Nov 25;385(22):2047-2058. doi: 10.1056/NEJMoa2103613.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blastocyst morphologic score, blastocyst biopsy and sequencing and freeze-all and single thawed blastocyst transfer in people with Infertility, run by Chen Zi-Jiang at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 20 Sep 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zi-Jiang Chen, Professor (+0086 531 85651190, chenzijiang@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative live birth rate (time frame: 22 months). 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 NCT03118141, which also lists 13 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 20 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.