An interventional study of IVF/ICSI and PGS in Infertility, Female and Abortion, Habitual, sponsored by ShangHai Ji Ai Genetics & IVF Institute. Completed at 1 site in China. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by ShangHai Ji Ai Genetics & IVF Institute · Not applicable, Interventional, and Treatment
Recurrent pregnancy loss (RPL) is a multifactorial disorder which affects about 1% of all couples and challenges both patients and clinicians technically and emotionally. IVF clinics see higher prevalence of RPL, since many RPL patients are seeking for assist reproduction treatment with or without other infertile factors. Guidelines for evaluation and treatment of RPL patients include screening for uterine abnormalities, parental chromosomes, autoimmune antibodies and cure gynecological infections, but there are still half of RPL patients remain unexplained.
The documented high incidence of chromosomal errors in first-trimester miscarriages and an increased rate of aneuploidy in patients with RPL has led to the theory that screening embryos before implantation for aneuploidy may decrease the risk of a subsequent loss and serve as a possible treatment. The technology, indications of use, and even terminology for genetic testing of embryos have greatly changed since the first PGD(pre-implantation genetic diagnosis) baby was born in 1990. The current best evidence shows blastocyst biopsy followed by new rapid comprehensive chromosome screening(termed pre-implantation chromosomal screening or comprehensive chromosome screening, PCS or CCS, or the investigators generally termed PGS) based on array-comprehensive genome hybridization(aCGH), single nucleotide polymorphism array(SNP-array) or next generation sequencing(NGS), to be the most powerful technology. However, for whom this PGS technique is most suitable to achieve improved clinical outcome have not yet been identified by well defined, ITT based research with carefully selected control and adequate sample size.
The investigators research is to determine whether in vitro fertilization (IVF)/ intracytoplasmic sperm injection (ICSI) combined with SNP-array based pre-implantation comprehensive chromosome screening (CCS) will improve the clinical outcome of infertile female patients with recurrent spontaneous abortion history.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 189 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →ShangHai Ji Ai Genetics & IVF Institute is the lead sponsor of 24 studies on the registry; 6 are open to participants now.
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Women 18-48 years of age who are scheduled for IVF or ICSI with a history of recurrent spontaneous abortion (continous miscarriage occurred earlier than 20 weeks of gestation for equal or greater than 2 times) in our IVF institute while meeting the following criteria:
Exclusion Criteria:
IVF/ICSI cycles with PGS. Select embryos by SNP-array based PGS for the number of all chromosomes on day 5, only euploid embryos will be transferred. A maximum of 2 embryos will be transferred for each treatment cycle. Up to 3 treatment cycles will be offered.
Procedure: IVF/ICSI · Genetic: PGS
IVF/ICSI cycles without PGS. Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle. Up to 3 treatment cycles will be offered.
Procedure: IVF/ICSI · Other: Without PGS
In vitro fertilization or intracytoplasmic sperm injection.
Selection of embryos are based on SNP-array-based preimplantation genetic screening for the number of all chromosomes on the 5th day of IVF/ICSI.
Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.
Ongoing pregnancy
Ongoing pregnancy is defined as a viable intrauterine pregnancy after 12 weeks of embryo transfer. Ongoing pregnancy rate per treatment cycle will also be calculated on intend-to-treat(ITT) basis.
Time frame: 12 weeks after embryo transfer for the patient
Implantation of transferred embryo
Implantation rate per embryo transferred will also be calculated.
Time frame: 2 weeks after embryo transfer for the patient
Clinical pregnancy
Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination. Clinical pregnancy rate per treatment cycle will also be calculated based on ITT.
Time frame: 4 weeks after embryo transfer for the patient
Time to pregnancy
Time to pregnancy is defined as from the first time 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 obtain ongoing pregnancy during the study period, the "time to pregnancy" will not be recorded for the specific patient or be calculated for the "average time to pregnancy" for the arm.
Time frame: from the date of the first time entering oocyte retrieval cycle until the embryo transfer day of a later assured ongoing pregnancy, accessed up to 24 months during the whole research period
Pregnancy outcome
abortion, live birth, multiple births, birth defect, preterm delivery, small-for-gestational age, still birth, maternal complications will be recorded.
Time frame: up to 42 days of a live birth
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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ShangHai Ji Ai Genetics & IVF Institute