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Trial record 42 of 1987 for:    infertility AND (woman OR women OR female)

Effects of PGS in Infertile Female Patients With RPL

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ClinicalTrials.gov Identifier: NCT02223221
Recruitment Status : Completed
First Posted : August 22, 2014
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Infertility, Female Abortion, Habitual Procedure: IVF/ICSI Genetic: PGS Other: Without PGS Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Preimplantation Genetic Screening for Aneuploidies in Infertile Female Patients With Recurrent Spontaneous Abortion History
Study Start Date : August 2014
Actual Primary Completion Date : July 31, 2016
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: With PGS

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
In vitro fertilization or intracytoplasmic sperm injection.

Genetic: PGS
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.

Active Comparator: Without 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
In vitro fertilization or intracytoplasmic sperm injection.

Other: Without PGS
Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.




Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer for the patient ]

    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.



Secondary Outcome Measures :
  1. Implantation of transferred embryo [ Time Frame: 2 weeks after embryo transfer for the patient ]
    Implantation rate per embryo transferred will also be calculated.

  2. Clinical pregnancy [ Time Frame: 4 weeks after embryo transfer for the patient ]

    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.


  3. Time to pregnancy [ 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 ]
    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.

  4. Pregnancy outcome [ Time Frame: up to 42 days of a live birth ]
    abortion, live birth, multiple births, birth defect, preterm delivery, small-for-gestational age, still birth, maternal complications will be recorded.



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Ages Eligible for Study:   18 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early follicular phase;
  2. no history of hormone medicine application in the last 3 months;
  3. no history of poison contact;
  4. normal uterine and adnexal ultrasonography;
  5. TORCH(-), chlamydia(-), mycoplasma(-), normal leucorrhoea routine, anti-phospholipid antibody (-), antinuclear antibody(-);
  6. for the couple, no blood type incompatibility or ABO antibody IgG≤1:64 and normal blood chromosome analysis.

Exclusion Criteria:

  1. hydrosalpinx without operation; endometriosis; polycystic ovary syndrome; adenomyosis; uterine leiomyomata(submucous myoma or non-submucous myoma which size was exceed 4cm and/or with the compressed endometrium);uterine cavity lesions(such as uterine malformation, intrauterine adhesions, the septate uterus, endometritis etc);
  2. the former abortion is because of luteal phase defect without treatment;
  3. thyroid dysfunction or increased CA125 level;
  4. acute inflammation of genitourinary system or STD carriers;
  5. unable to comply with the study procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223221


Locations
China
Shanghai Jiai Genetics & IVF Institute
Shanghai, China, 200011
Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
Study Director: XIAOXI SUN, MD Shanghai Jiai Genetics & IVF Institute
Principal Investigator: YILUN SUI, MD Shanghai Jiai Genetics & IVF Institute

Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT02223221     History of Changes
Other Study ID Numbers: JIAI E2014-02
First Posted: August 22, 2014    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by ShangHai Ji Ai Genetics & IVF Institute:
In Vitro Fertilization
Intracytoplasmic Sperm Injections
Infertility, Female
Abortion, Habitual
recurrent pregnancy loss
comprehensive chromosome screening
preimplantation genetic screening
SNP array

Additional relevant MeSH terms:
Infertility
Infertility, Female
Abortion, Habitual
Genital Diseases, Male
Genital Diseases, Female
Abortion, Spontaneous
Pregnancy Complications