AzTrials
AzTrials

Infertility, FemaleNCT02223221

Effects of PGS in Infertile Female Patients With RPL

A study testing IVF/ICSI, PGS and Without PGS in people with Infertility, Female and Abortion, Habitual, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 48 years, women only
Conditions the study is for
Infertility, Female, Abortion, Habitual
What is being tested?
IVF/ICSI, PGS and Without PGS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
189 participants
Where
1 siteChina
Study dates
Aug 2014to 30 Apr 2017
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 18 to 48 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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);
  • the former abortion is because of luteal phase defect without treatment;
  • thyroid dysfunction or increased CA125 level;
  • acute inflammation of genitourinary system or STD carriers;
  • unable to comply with the study procedures.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Jiai Genetics & IVF Institute

    Shanghai, 200011

Other trials in China

About this study

Official title: Effects of Preimplantation Genetic Screening for Aneuploidies in Infertile Female Patients With Recurrent Spontaneous Abortion History

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.

Being tested
IVF/ICSI, PGS, Without PGS
Keywords
In Vitro Fertilization, Intracytoplasmic Sperm Injections, Infertility, Female, Abortion, Habitual, recurrent pregnancy loss, comprehensive chromosome screening, preimplantation genetic screening, SNP array
Medical subject headings
Infertility, Female, Abortion, Habitual

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 intracytoplasmic sperm injection.

  • PGSGenetic

    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.

  • Without PGSOther

    Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.

Study groups in NCT02223221
Study groupRoleWhat they receive
With PGSExperimentalIVF/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.
Receives: Procedure: IVF/ICSI; Genetic: PGS
Without PGSActive comparatorIVF/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.
Receives: Procedure: IVF/ICSI; Other: Without PGS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks after embryo transfer for the patient

Secondary outcomes (4)

  1. Implantation of transferred embryo

    Implantation rate per embryo transferred will also be calculated.

    Measured: 2 weeks after embryo transfer for the patient

  2. 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.

    Measured: 4 weeks after embryo transfer for the patient

  3. 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.

    Measured: 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

  4. Pregnancy outcome

    abortion, live birth, multiple births, birth defect, preterm delivery, small-for-gestational age, still birth, maternal complications will be recorded.

    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.

  1. First posted22 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completion31 Jul 2016
  4. Study completion30 Apr 2017

Resources

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
Care provider
Enrolment
189 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02223221
Sponsor's protocol ID
JIAI E2014-02
Status last verified
Jul 2017
First submitted
18 Aug 2014
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32898291

Questions about this trial

What is this clinical trial studying?

A study testing IVF/ICSI, PGS and Without PGS in people with Infertility, Female and Abortion, Habitual, 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 11 Jul 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy (time frame: 12 weeks after embryo transfer for the patient). 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 NCT02223221, which also lists 1 linked publication.

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 11 Jul 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in