Condition category
Urological and Genital Diseases
Date applied
18/11/2011
Date assigned
09/12/2011
Last edited
12/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In vitro fertilisation (IVF) is a technique to help people with fertility problems to have a baby. During IVF, an egg is removed from the woman's ovaries and fertilised with sperm in a laboratory (intra-cytoplasmic sperm injection [ICSI]). The fertilised egg (embryo) is then returned to the woman's womb to grow and develop. Preimplantation genetic screening (PGS) involves checking the embryos for common chromosome abnormalities. PGS has mainly involved checking a limited number of chromosomes (5-9 chromosomes). Embryos with the correct number of chromosomes are selected for transfer to the woman's womb. However, this test has produced contradictory results that can be explained by technical differences and the limited number of chromosomes assessed. The 24 chromosomes array-comparative genomic hybridization (array-CGH) PGS test involves assessing all 24 chromosomes, which may overcome the technical difficulties that beset earlier PGS studies. Therefore, the aim of this study is to find out whether PGS for all 24 chromosomes by array-CGH increases pregnancy and live birth rates.

Who can participate?
Women aged 36 or younger with a history of more than two failed IVF/ICSI cycles without pregnancy

What does the study involve?
Participants are randomly allocated to undergo ICSI either with or without PGS for all 24 chromosomes by array-CGH. The morphology (shape) of the embryos obtained and the pregnancy and live birth rates in both groups are compared.

What are the possible benefits and risks of participating?
PGS is provided free of charge and may improve the participants’ odds of conceiving. The information obtained from this study may also help to advance the science involved with PGS in IVF. Egg retrieval is a common procedure, but complications can still sometimes occur. There are risks involved with any treatment involving fertility drugs and egg retrieval.

Where is the study run from?
GENOMA Molecular Genetics Laboratory (Italy)

When is the study starting and how long is it expected to run for?
December 2011 to December 2012

Who is funding the study?
1. BlueGnome (UK)
2. GENOMA Molecular Genetics Laboratory (Italy)
3. Genera (Italy)

Who is the main contact?
Dr Francesco Fiorentino
fiorentino@laboratoriogenoma.it

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francesco Fiorentino

ORCID ID

Contact details

Via di Castel Giubileo
11
Rome
00138
Italy
+39 (0)68 811 270
fiorentino@laboratoriogenoma.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18112011

Study information

Scientific title

Preimplantation genetic screening (PGS) by array-comparative genomic hybridization (CGH) on day 5 embryos with day 6 fresh transfer in repeated implantation failure (RIF) patients: a randomised double-blinded study

Acronym

Study hypothesis

Patients with repeated implantation failure (RIF) have a higher ongoing pregnancy rate and live birth rate after embryo transfer of embryos with a normal chromosomal pattern analysed by 24 chromosome aneuploidy screeninig (PGS) compared with patients who had an embryo transfer on day 6 without PGS.

Ethics approval

The Local Ethics Committee (Genoma, Rome, Italy), 18/10/2011

Study design

Prospective randomised double-blinded study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Infertility

Intervention

Control group: ICSI procedure, day 5 Laser Assisted drilling without Preimplantaion Genetic Screening, day 6 embryo transfer

Study group: ICSI and Preimplantation Genetic Screening with array-CGH, embryo biopsy on day 5, day 6 embryo transfer

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Live birth rate [Time Frame: 1 year after embryo transfer]; pregnancies that arrive to term divided by procedures with an egg retrieval

Secondary outcome measures

1. Ongoing pregnancy rate per embryo transfer [Time Frame: 20 weeks after embryo transfer]. Ongoing pregnancy defined as the presence of a fetal sac. Pregnancy rate per transfer defined as pregnancies divided by patients with a replacement of embryos.
2. Pregnancy rate per retrieval [Time Frame: 20 weeks after embryo transfer]. pregnancy defined as the presence of a fetal sac. Pregnancy rate per retrieval defined as pregnancies divided by patients with an egg retrieval.
3. Ongoing pregnancy rate per started cycle [ Time Frame: 20 weeks after embryo transfer ]
4. Ongoing implantation rate [Time Frame: 12 weeks after embryo transfer ]
5. Number of embryos implanted divided by number of embryos replaced. An embryo implanted is measured as a fetal sac by ultrasound observation.
6. Embryo transfer rate per started cycle

Overall trial start date

01/12/2011

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients aged 36 years old or younger undergoing an Intra-cytoplasmic sperm injection (ICSI) attempt at GENERA Clinic in Rome
2. History of more than two failed In vitro fertilisation (IVF)/ICSI cycles; without clinical pregnancy with transfer of at least one good quality embryos per transfer
3 .≥6 metaphase II (MII) oocytes retrieved
4. Signed consent form

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

1. Azoospermic male partner
2. Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml
3. Hydrosalpinx
4. Polycystic ovary syndrome (PCOS)
5. Pre-implantation genetic diagnosis (PGD) cycles [Single Gene Disorders (SGD) or Translocations or other chromosomal abmormalities]
6. Female patients with pathological uterine cavity
7. Number of retrieved MII oocytes < 6
8. Known American Society for Reproductive Medicine (ASRM) Grade III or IV endometriosis
9. Maternal disease that is not clinically stable and known to impact the ability to become pregnant or carry a pregnancy to term (lupus, chronic liver or kidney disease, body mass index (BMI) >35, uncontrolled hypertension, anti-phospholipid antibody, thrombophilia, insulin dependent diabetes)

Recruitment start date

01/12/2011

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Italy

Trial participating centre

Via di Castel Giubileo, 11
Rome
00138
Italy

Sponsor information

Organisation

BlueGnome Ltd (UK)

Sponsor details

Breaks House
Mill Court
Great Shelford
Cambridge
CB22 5LD
United Kingdom
+44 (0)122 384 4441
info@cambridgebluegnome.com

Sponsor type

Industry

Website

http://www.cambridgebluegnome.com/

Funders

Funder type

Industry

Funder name

Genoma Molecular Genetics Laboratory (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Genera (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BlueGnome (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/06/2017: Plain English summary added.