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Effects of PGS2.0 in Patients With Unexplained RPL

Primary Purpose

Recurrent Pregnancy Loss, Infertility, Female

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

IVF/ICSI

PGS 2.0

Conventional embryo morphology evaluation

About this trial

This is an interventional treatment trial for Recurrent Pregnancy Loss focused on measuring unexplained recurrent pregnancy loss, infertility, female, preimplantation genetic screening, in vitro fertilization, intracytoplasmic sperm injection

Eligibility Criteria

20 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion criteria:

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.

Sites / Locations

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

With PGS 2.0

Without PGS 2.0

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Live birth rate per initiated cycle

live birth rate of a baby per oocyte retrieval cycle initiated

Secondary Outcome Measures

Embryo implantation

positive serum hCG after 2 weeks of embryo transfer

Clinical pregnancy

the presence of a gestational sac confirmed by transvaginal ultrasound examination

Ongoing pregnancy

the fetal heat beat continued at 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.

Pregnancy outcome

abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth

Full Information

NCT ID

NCT03214185

First Posted

July 9, 2017

Last Updated

February 4, 2018

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Collaborators

The International Peace Maternity & Child Health Hospital of China welfare institute, RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03214185

Brief Title

Effects of PGS2.0 in Patients With Unexplained RPL

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 6, 2018 (Anticipated)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

September 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Collaborators

The International Peace Maternity & Child Health Hospital of China welfare institute, RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Pregnancy Loss, Infertility, Female

Keywords

unexplained recurrent pregnancy loss, infertility, female, preimplantation genetic screening, in vitro fertilization, intracytoplasmic sperm injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

710 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

With PGS 2.0

Arm Type

Experimental

Arm Description

Arm Title

Without PGS 2.0

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

IVF/ICSI

Intervention Description

in vitro fertilization or intracytoplasmatic sperm injection

Intervention Type

Genetic

Intervention Name(s)

PGS 2.0

Intervention Description

Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred.

Intervention Type

Other

Intervention Name(s)

Conventional embryo morphology evaluation

Intervention Description

Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.

Primary Outcome Measure Information:

Title

Live birth rate per initiated cycle

Description

live birth rate of a baby per oocyte retrieval cycle initiated

Time Frame

up to 42 days of a live birth

Secondary Outcome Measure Information:

Title

Embryo implantation

Description

positive serum hCG after 2 weeks of embryo transfer

Time Frame

2 weeks after embryo transfer

Title

Clinical pregnancy

Description

the presence of a gestational sac confirmed by transvaginal ultrasound examination

Time Frame

4 weeks after embryo transfer

Title

Ongoing pregnancy

Description

the fetal heat beat continued at 10 weeks after embryo transfer

Time Frame

10 weeks after embryo transfer

Title

Time to pregnancy

Description

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.

Title

Pregnancy outcome

Description

abortion, multiple birth, birth defects, preterm delivery, small for gestational age, still birth

Time Frame

up to 42 days of a live birth

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

37 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

CAIXIA LEI, MD

Phone

86-18917958213

green3318@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

XIAOXI SUN, PHD

Phone

86-21-63456043

xiaoxi_sun@aliyun.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

XIAOXI SUN, PHD

Organizational Affiliation

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

Official's Role

Study Chair

Facility Information:

Facility Name

Shanghai Ji Ai Genetics & IVF Institute, Obstetrics and Gynecology Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CAIXIA LEI, MD

Phone

86-18917958213

green3318@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23095139

Citation

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.

Results Reference

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PubMed Identifier

25376455

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.

Results Reference

background

PubMed Identifier

22683012

Citation

Hodes-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.

Results Reference

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PubMed Identifier

23731996

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.

Results Reference

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PubMed Identifier

23548942

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.

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PubMed Identifier

26385405

Citation

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.

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PubMed Identifier

25599824

Citation

Dahdouh 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.

Results Reference

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PubMed Identifier

27256483

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, 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.

Results Reference

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PubMed Identifier

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Citation

Lei 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.

Results Reference

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PubMed Identifier

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Citation

Cornelisse 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.

Results Reference

derived

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Effects of PGS2.0 in Patients With Unexplained RPL

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