Effects of PGS in Infertile Female Patients With RPL

NCT ID: NCT02223221

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

IVF/ICSI

Intervention Type: PROCEDURE

In vitro fertilization or intracytoplasmic sperm injection.

PGS

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

IVF/ICSI

Intervention Type: PROCEDURE

In vitro fertilization or intracytoplasmic sperm injection.

Without PGS

Intervention Type: OTHER

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

Interventions

IVF/ICSI

In vitro fertilization or intracytoplasmic sperm injection.

Intervention Type: PROCEDURE

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.

Intervention Type: GENETIC

Without PGS

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

XIAOXI SUN, MD

Role: STUDY_DIRECTOR

Shanghai Jiai Genetics & IVF Institute

YILUN SUI, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiai Genetics & IVF Institute

Locations

Shanghai Jiai Genetics & IVF Institute

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32898291 (View on PubMed)

Other Identifiers

JIAI E2014-02

Identifier Type: -

Identifier Source: org_study_id