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NCT Number: NCT02223221

Effects of PGS in Infertile Female Patients With RPL

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.

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Key information

Conditions

Infertility, Female Abortion, Habitual Abortion, Spontaneous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Pregnancy Complications Urogenital Diseases

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiai Genetics & IVF Institute

Shanghai, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

IVF/ICSI

Procedure

In vitro fertilization or intracytoplasmic sperm injection.

PGS

Genetic

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 PGS

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 22, 2014
Registry last updated
Jul 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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