Effects of PGS in Infertile Female Patients With RPL

NCT02223221 | Completed DMC

• 1 other identifier: JIAI E2014-02
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female; Abortion, Habitual

Keywords

In Vitro Fertilization; Intracytoplasmic Sperm Injections; Infertility, Female; Abortion, Habitual; recurrent pregnancy loss; comprehensive chromosome screening; preimplantation genetic screening; SNP array

Outcome Measures

Primary Outcomes (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.

  12 weeks after embryo transfer for the patient

Secondary Outcomes (4)

• Implantation of transferred embryo

  2 weeks after embryo transfer for the patient

• Clinical pregnancy

  4 weeks after embryo transfer for the patient

• Time to pregnancy

  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

  up to 42 days of a live birth

Study Arms (2)

With PGS

EXPERIMENTAL

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

Without PGS

ACTIVE COMPARATOR

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

Interventions

IVF/ICSI PROCEDURE

In vitro fertilization or intracytoplasmic sperm injection.

With PGS; Without PGS

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.

With PGS

Without PGS OTHER

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

Without PGS

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai Jiai Genetics & IVF Institute

Shanghai, 200011, China

Location

Related Publications (1)

• 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.

  PMID: 32898291 DERIVED

MeSH Terms

Conditions

Infertility, Female; Abortion, Habitual

Interventions

Phosphatidylglycerols

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• XIAOXI SUN, MD

  Shanghai Jiai Genetics & IVF Institute

  STUDY DIRECTOR

• YILUN SUI, MD

  Shanghai Jiai Genetics & IVF Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: August 22, 2014
• Study Start: August 1, 2014
• Primary Completion: July 31, 2016
• Study Completion: April 30, 2017
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

CN (1)