Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03214185
Other study ID # JIAI E2017-15
Secondary ID
Status Recruiting
Phase N/A
First received July 9, 2017
Last updated February 4, 2018
Start date February 6, 2018
Est. completion date September 30, 2021

Study information

Verified date July 2017
Source ShangHai Ji Ai Genetics & IVF Institute
Contact CAIXIA LEI, MD
Phone 86-18917958213
Email green3318@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 710
Est. completion date September 30, 2021
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 37 Years
Eligibility Inclusion criteria:

1. The couple has experienced two or more failed pregnancies (according to ASRM definition).

2. The karyotypes of both husband and wife are normal (polymorphic chromosomes are considered normal either).

3. Women ages =20 and <38 years old.

Exclusion criteria:

1. 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.

2. 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).

3. 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.

Study Design


Intervention

Procedure:
IVF/ICSI
in vitro fertilization or intracytoplasmatic sperm injection
Genetic:
PGS 2.0
Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred.
Other:
Conventional embryo morphology evaluation
Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.

Locations

Country Name City State
China Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University Shanghai Shanghai

Sponsors (3)

Lead Sponsor Collaborator
ShangHai Ji Ai Genetics & IVF Institute Renji Hospital, Shanghai Jiao Tong University School of Medicine, The International Peace Maternity & Child Health Hospital of China welfare institute

Country where clinical trial is conducted

China, 

References & Publications (8)

Dahdouh EM, Balayla J, García-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. Review. — View Citation

Dahdouh EM, Balayla J, García-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. Review. — View Citation

Forman 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. — View Citation

Hodes-Wertz B, Grifo J, Ghadir S, Kaplan B, Laskin CA, Glassner M, Munné 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. — View Citation

Kolte 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. Review. — View Citation

Practice Committee of 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. — View Citation

Scott 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. — View Citation

Sermon 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, Munné 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Live birth rate per initiated cycle live birth rate of a baby per oocyte retrieval cycle initiated up to 42 days of a live birth
Secondary Embryo implantation positive serum hCG after 2 weeks of embryo transfer 2 weeks after embryo transfer
Secondary Clinical pregnancy the presence of a gestational sac confirmed by transvaginal ultrasound examination 4 weeks after embryo transfer
Secondary Ongoing pregnancy the fetal heat beat continued at 10 weeks after embryo transfer 10 weeks after embryo transfer
Secondary 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. 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.
Secondary Pregnancy outcome abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth up to 42 days of a live birth
See also
  Status Clinical Trial Phase
Recruiting NCT05969574 - Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?
Recruiting NCT05358483 - PROspective Study of Mothers' and Infants' Social and Epidemiologic Determinants of Health
Recruiting NCT05969795 - Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support Phase 1
Recruiting NCT06051201 - Innovation for Small-scale Experiments: ReceptIVFity Test N/A
Completed NCT03177538 - Corifollitropin Alfa Combined With Menotropin Versus Follitropin and Lutropin Alfa in Expected Suboptimal Responders Phase 4
Completed NCT03638856 - Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy N/A
Completed NCT04052464 - The Study of the Implantation Window From Endometrial Biopsy With Gene Expression Methods
Withdrawn NCT04753736 - Immunophenotypage of RIF and RM Patients and Intrauterine Administration of PBMC N/A
Completed NCT03349905 - Deferred Versus Fresh Embryo Transfers N/A
Completed NCT05076981 - Progesterone Levels During Ovulation and Luteal Phase
Completed NCT04096027 - Cabergoline Before or After Oocyte Collection for Follicular Resolution Phase 4
Recruiting NCT05980091 - Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration. Phase 1
Terminated NCT01933633 - Improved Fertility After Exercise in Overweight/Obese Women N/A
Terminated NCT01202643 - Effect of Colony Stimulating Factor on Poor Endometrial Development During IVF Phase 1/Phase 2
Completed NCT01202656 - Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization) Phase 1/Phase 2
Completed NCT01408615 - A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)
Enrolling by invitation NCT05698550 - The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET Phase 3
Not yet recruiting NCT03910582 - Personalized FET in RIF Patients With Displaced Dating N/A
Completed NCT05440019 - Evaluation of the Safety and Usability of the M3T Fertigo System and Its Calibration
Completed NCT05130125 - Retrospective Cohort Observational Study to Evaluate the Effectiveness and Safety of Fresh or Frozen Embryo Transfer