Recurrent Pregnancy LossNCT03214185
Effects of PGS2.0 in Patients With Unexplained RPL
A study testing IVF/ICSI, PGS 2.0 and Conventional embryo morphology evaluation in people with Recurrent Pregnancy Loss and Infertility, Female, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.
Trial summary
50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Infertility, Female
- What is being tested?
- IVF/ICSI, PGS 2.0 and Conventional embryo morphology evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2018to 30 Sep 2021
- 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
- The couple has experienced two or more failed pregnancies (according to ASRM definition).
- The karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either).
- 3. Women ages ≥20 and <38 years old.
Who cannot join
- the wife has history of the following diseases: a, the history of thyroid disease; b, the history of adrenal diseases; c, the history of sexually transmitted diseases; d, the history of hereditary diseases; e, the history of mental and psychological disorders.
- the wife has the following uterine abnormalities: a, uterine malformations (uterus unicorns and duplex uterus), untreated septate uterus, adenomyoma, submucous uterine fibroids, endometrial polyps, or intrauterine adhesions (including the history of intrauterine adhesions).
- the wife has a medical condition that contraindicate ART or pregnancy, including poorly controlled type I or type II diabetes; undiagnosed liver and renal disease or liver and renal insufficiency (based on blood test); deep vein thrombosis; pulmonary embolism; history of cerebrovascular accident; uncontrolled hypertension; cardiac disease; carcinoma; severe anemia; suspicious or undiagnosed vaginal bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
Shanghai, Shanghai Municipality, 200011
CAIXIA LEI, MD, 86-18917958213, green3318@163.com
About this study
Official title: Effects of Preimplantation Genetic Screening 2.0 on the Clinical Outcomes of Assisted Reproductive Treatment in Patients With Recurrent Pregnancy Loss : A Multi-center-based Prospective Randomized Clinical Trial
50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. In dispute though the clinical application of PGS has been, a series of studies show that the new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis, has significantly improved the clinical outcome of IVF treatment. At present, there is still a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this emerging technology considering the prevalence of genetic abnormalities and the number of transferable embryos in this population.
An earlier single center RCT conducted by our IVF center displayed higher implantation rate, clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET) cycle in IVF/ICSI+PGS group compared with IVF/ICSI group.
This multi-center prospective randomized clinical trial is to provide more data to determine whether the clinical outcomes are significantly improved per treatment cycle such that provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS outcome are to be analyzed from multi-center data to build a model for prediction of the possible outcomes of PGS and direction of the clinical choice.
- Conditions
- Recurrent Pregnancy Loss, Infertility, Female
- Being tested
- IVF/ICSI, PGS 2.0, Conventional embryo morphology evaluation
- Keywords
- unexplained recurrent pregnancy loss, infertility, female, preimplantation genetic screening, in vitro fertilization, intracytoplasmic sperm injection
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF/ICSIProcedure or surgery
in vitro fertilization or intracytoplasmatic sperm injection
PGS 2.0Genetic
Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred.
Conventional embryo morphology evaluationOther
Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.
| Study group | Role | What they receive |
|---|---|---|
| With PGS 2.0 | Experimental | Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,conventional embryo morphology evaluation and trophectoderm biopsy before blastocyst cryopreservation. Preimplantation genetic screening (PGS) will be performed to select euploid embryo. The patients will go through up to three times of frozen-thawed transfers of euploid blastocysts until ongoing pregnancy or live birth is acquired. Only one euploid blastocyst will be transferred at a time. Receives: Procedure: IVF/ICSI; Genetic: PGS 2.0 |
| Without PGS 2.0 | Active comparator | Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,and conventional embryo morphology evaluation before blastocyst cryopreservation. The patients will go through up to three times of frozen-thawed transfers of good quality blastocysts until ongoing pregnancy or live birth is acquired. Only one good quality blastocyst will be transferred at a time. Receives: Procedure: IVF/ICSI; Other: Conventional embryo morphology evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate per initiated cycle
live birth rate of a baby per oocyte retrieval cycle initiated
Measured: up to 42 days of a live birth
Secondary outcomes (5)
Embryo implantation
positive serum hCG after 2 weeks of embryo transfer
Measured: 2 weeks after embryo transfer
Clinical pregnancy
the presence of a gestational sac confirmed by transvaginal ultrasound examination
Measured: 4 weeks after embryo transfer
Ongoing pregnancy
the fetal heat beat continued at 10 weeks after embryo transfer
Measured: 10 weeks after embryo transfer
Time to pregnancy
From the day of entering oocyte retrieval cycle to the embryo transfer day of a later assured ongoing pregnancy,which is up to 24 months within the study period.If the patient fails to obtain ongoing pregnancy during the study period, this outcome measure will not be recorded.
Measured: From the day of entering oocyte retrieval cycle to the embryo transfer day of a later assured ongoing pregnancy,which is up to 24 months within the study period.
Pregnancy outcome
abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth
Measured: up to 42 days of a live birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start6 Feb 2018 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The International Peace Maternity & Child Health Hospital of China welfare institute, RenJi Hospital
- Responsible party
- Sponsor
- Investigators
- XIAOXI SUN, PHD, Study chair, Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214185
- Sponsor's protocol ID
- JIAI E2017-15
- Status last verified
- Jul 2017
- First submitted
- 9 Jul 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.
PubMed 23095139Kolte AM, Bernardi LA, Christiansen OB, Quenby S, Farquharson RG, Goddijn M, Stephenson MD; ESHRE Special Interest Group, Early Pregnancy. Terminology for pregnancy loss prior to viability: a consensus statement from the ESHRE early pregnancy special interest group. Hum Reprod. 2015 Mar;30(3):495-8. doi: 10.1093/humrep/deu299. Epub 2014 Nov 5.
PubMed 25376455Hodes-Wertz B, Grifo J, Ghadir S, Kaplan B, Laskin CA, Glassner M, Munne S. Idiopathic recurrent miscarriage is caused mostly by aneuploid embryos. Fertil Steril. 2012 Sep;98(3):675-80. doi: 10.1016/j.fertnstert.2012.05.025. Epub 2012 Jun 7.
PubMed 22683012Scott 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 23731996Forman 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 23548942Dahdouh 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 26385405Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.
PubMed 25599824Sermon K, Capalbo A, Cohen J, Coonen E, De Rycke M, De Vos A, Delhanty J, Fiorentino F, Gleicher N, Griesinger G, Grifo J, Handyside A, Harper J, Kokkali G, Mastenbroek S, Meldrum D, Meseguer M, Montag M, Munne S, Rienzi L, Rubio C, Scott K, Scott R, Simon C, Swain J, Treff N, Ubaldi F, Vassena R, Vermeesch JR, Verpoest W, Wells D, Geraedts J. The why, the how and the when of PGS 2.0: current practices and expert opinions of fertility specialists, molecular biologists, and embryologists. Mol Hum Reprod. 2016 Aug;22(8):845-57. doi: 10.1093/molehr/gaw034. Epub 2016 Jun 2.
PubMed 27256483Lei C, Sui Y, Ye J, Lu Y, Xi J, Sun Y, Jin L, Sun X. Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial. BMJ Open. 2020 Oct 7;10(10):e036252. doi: 10.1136/bmjopen-2019-036252.
PubMed 33033011Cornelisse 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 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preimplantation Genetic Screening 2.0 on the Clinical Outcomes of Assisted Reproductive Treatment in Patients With Recurrent Pregnancy Loss : A Multi-center-based Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03214185
- Acronym / sponsor ID
- JIAI E2017-15
- Conditions
- Recurrent Pregnancy Loss, Infertility, Female
- Keywords
- unexplained recurrent pregnancy loss, infertility, female, preimplantation genetic screening, in vitro fertilization, intracytoplasmic sperm injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- ShangHai Ji Ai Genetics & IVF InstituteUniversity, hospital or other
- Collaborators
- The International Peace Maternity & Child Health Hospital of China welfare institute, RenJi Hospital
- Study start
- 6 Feb 2018 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 11 Jul 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.
50%-60% of the known causes of recurrent pregnancy loss(RPL) are associated with embryonic aneuploidy, such that preimplantation genetic screening (PGS) on embryos acquired by assisted reproductive treatment should improve the rate of pregnancy and live birth in those patients. In dispute though the clinical application of PGS has been, a series of studies show that the new generation of PGS(PGS 2.0), based on blastocyst biopsy followed by whole genome analysis, has significantly improved the clinical outcome of IVF treatment. At present, there is still a need for the evidence of the use of PGS 2.0 in RPL patients, who may benefit from this emerging technology considering the prevalence of genetic abnormalities and the number of transferable embryos in this population.
An earlier single center RCT conducted by our IVF center displayed higher implantation rate, clinical pregnancy rate and ongoing pregnancy rate calculated by per embryo transfer(ET) cycle in IVF/ICSI+PGS group compared with IVF/ICSI group.
This multi-center prospective randomized clinical trial is to provide more data to determine whether the clinical outcomes are significantly improved per treatment cycle such that provide evidence for the application of PGS in RPL patients. Besides, risk factors of PGS outcome are to be analyzed from multi-center data to build a model for prediction of the possible outcomes of PGS and direction of the clinical choice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With PGS 2.0 | Experimental | Procedure: IVF/ICSI, Genetic: PGS 2.0Patients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,conventional embryo morphology evaluation and trophectoderm biopsy before blastocyst cryopreservation. Preimplantation genetic screening (PGS) will be performed to select euploid embryo. The patients will go through up to three times of frozen-thawed transfers of euploid blastocysts until ongoing pregnancy or live birth is acquired. Only one euploid blastocyst will be transferred at a time. |
| Without PGS 2.0 | Active comparator | Procedure: IVF/ICSI, Other: Conventional embryo morphology evaluationPatients will undergo IVF/ICSI procedure, and experience oocyte aspiration, fertilization,blastocyst formation,and conventional embryo morphology evaluation before blastocyst cryopreservation. The patients will go through up to three times of frozen-thawed transfers of good quality blastocysts until ongoing pregnancy or live birth is acquired. Only one good quality blastocyst will be transferred at a time. |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The couple has experienced two or more failed pregnancies (according to ASRM definition).
- The karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either).
- 3. Women ages ≥20 and <38 years old.
Key exclusion criteria (3 listed)
- the wife has history of the following diseases: a, the history of thyroid disease; b, the history of adrenal diseases; c, the history of sexually transmitted diseases; d, the history of hereditary diseases; e, the history of mental and psychological disorders.
- the wife has the following uterine abnormalities: a, uterine malformations (uterus unicorns and duplex uterus), untreated septate uterus, adenomyoma, submucous uterine fibroids, endometrial polyps, or intrauterine adhesions (including the history of intrauterine adhesions).
- the wife has a medical condition that contraindicate ART or pregnancy, including poorly controlled type I or type II diabetes; undiagnosed liver and renal disease or liver and renal insufficiency (based on blood test); deep vein thrombosis; pulmonary embolism; history of cerebrovascular accident; uncontrolled hypertension; cardiac disease; carcinoma; severe anemia; suspicious or 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 |
|---|---|---|
| IVF/ICSIin vitro fertilization or intracytoplasmatic sperm injection | Procedure or surgery | With PGS 2.0, Without PGS 2.0 |
| PGS 2.0Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred. | Genetic | With PGS 2.0 |
| Conventional embryo morphology evaluationBlastocysts are selected by morphology criteria and only good-scored embryo will be transferred. | Other | Without PGS 2.0 |
Primary outcome
Live birth rate per initiated cycle
Time frame: up to 42 days of a live birth
live birth rate of a baby per oocyte retrieval cycle initiated
5 secondary outcomes
Embryo implantation
Time frame: 2 weeks after embryo transfer
Clinical pregnancy
Time frame: 4 weeks after embryo transfer
Ongoing pregnancy
Time frame: 10 weeks after embryo transfer
Time to pregnancy
Time frame: From the day of entering oocyte retrieval cycle to the embryo transfer day of a later assured ongoing pregnancy,which is up to 24 months within the study period.
Pregnancy outcome
Time frame: up to 42 days of a live birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Background: PubMed 23095139Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 Jan;99(1):63. doi: 10.1016/j.fertnstert.2012.09.023. Epub 2012 Oct 22.
- Background: PubMed 25376455Kolte AM, Bernardi LA, Christiansen OB, Quenby S, Farquharson RG, Goddijn M, Stephenson MD; ESHRE Special Interest Group, Early Pregnancy. Terminology for pregnancy loss prior to viability: a consensus statement from the ESHRE early pregnancy special interest group. Hum Reprod. 2015 Mar;30(3):495-8. doi: 10.1093/humrep/deu299. Epub 2014 Nov 5.
- Background: PubMed 22683012Hodes-Wertz B, Grifo J, Ghadir S, Kaplan B, Laskin CA, Glassner M, Munne S. Idiopathic recurrent miscarriage is caused mostly by aneuploid embryos. Fertil Steril. 2012 Sep;98(3):675-80. doi: 10.1016/j.fertnstert.2012.05.025. Epub 2012 Jun 7.
- 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 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 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 25599824Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.
- Background: PubMed 27256483Sermon K, Capalbo A, Cohen J, Coonen E, De Rycke M, De Vos A, Delhanty J, Fiorentino F, Gleicher N, Griesinger G, Grifo J, Handyside A, Harper J, Kokkali G, Mastenbroek S, Meldrum D, Meseguer M, Montag M, Munne S, Rienzi L, Rubio C, Scott K, Scott R, Simon C, Swain J, Treff N, Ubaldi F, Vassena R, Vermeesch JR, Verpoest W, Wells D, Geraedts J. The why, the how and the when of PGS 2.0: current practices and expert opinions of fertility specialists, molecular biologists, and embryologists. Mol Hum Reprod. 2016 Aug;22(8):845-57. doi: 10.1093/molehr/gaw034. Epub 2016 Jun 2.
- Derived from this study: PubMed 33033011Lei C, Sui Y, Ye J, Lu Y, Xi J, Sun Y, Jin L, Sun X. Comparison of PGS2.0 versus conventional embryo morphology evaluation for patients with recurrent pregnancy loss: a study protocol for a multicentre randomised trial. BMJ Open. 2020 Oct 7;10(10):e036252. doi: 10.1136/bmjopen-2019-036252.
- Derived from this study: PubMed 32898291Cornelisse 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.
- 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.
XIAOXI SUN, PHD study chair
Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVF/ICSI, PGS 2.0 and Conventional embryo morphology evaluation in people with Recurrent Pregnancy Loss and Infertility, Female, run by ShangHai Ji Ai Genetics & IVF Institute 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 3 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 6 Feb 2018. 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 CAIXIA LEI, MD (86-18917958213, green3318@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate per initiated cycle (time frame: up to 42 days of a live birth). 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 NCT03214185, which also lists 10 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 6 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.