Condition category
Pregnancy and Childbirth
Date applied
10/11/2010
Date assigned
20/12/2010
Last edited
20/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Laura Rienzi

ORCID ID

Contact details

GENERA
Clinica valle Giulia
Via de Notaris 2B
Rome
00197
Italy
+39 (0)6 3269791
rienzi@generaroma.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N°GENERA 201003

Study information

Scientific title

Preimplantation genetic screening on day 3 embryos using Comparative Genomic Hybridization (CGH)-array in women of advanced maternal age: a prospective randomised controlled trial

Acronym

PGS by CGH-array on day 3 embryos in AMA patients

Study hypothesis

Patients with advanced maternal age (AMA) (36 - 43 years) have a higher ongoing pregnancy rate after embryo transfer of embryos with a normal chromosomal pattern analysed through 24-chromosome aneuploidy preimplantation genetic screening (PGS) compared with patients who had an embryo transfer without PGS.

Ethics approval

The local ethics committee (Clinica Valle Giulia, Rome, Italy) approved on the 20th October 2010

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 contact details below to requset a patient information sheet

Condition

Infertility

Intervention

1. Control group: ICSI procedure, day 3 zona pellucida laser assisted drilling without blastomere biopsy and Preimplantaion Genetic Screening (PGS), day 5 up to double embryo transfer .

2. Study group: ICSI, one-cell embryo biopsy on day 3 and Preimplantation Genetic Screening with array-CGH, day 5 up to double embryo transfer. Embryos with dubious results will be reanalysed by trofoblast biopsy and array-CGH.

All available supenumerary viable embryos will be cryopreserved by vitrification procedure in both groups.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Ongoing pregnancy rate per embryo transfer (defined as the ratio between the number of
ongoing prergnancy greater than 20 weeks gestation and the number of embryo transfer performed)

Secondary outcome measures

1. Embryo transfer rate per started cycle
2. Ongoing implantation rate
3. Miscarriage rate
4. Multiple pregnancy rate
5. Ongoing pregnancy rate per started cycle

Overall trial start date

01/11/2010

Overall trial end date

01/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients aged between 36 and 43 years undergoing an in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) attempt at the GENERA centre for Reproductive Medicine in Rome
2. History of less than 3 consecutive miscarriages and no more than 2 failed IVF/ICSI cycles
3. Greater than or equal to 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 less than 1 million sperm/ml
3. Hydrosalpinx
4. Polycystic ovarian syndrome (PCOS)
5. Preimplantation genetic diagnosis (PGD) cycles for monogenic defects and/or chromosomal structural abnormalities
6. Female patients with pathological uterine cavity
7. Number of retrieved MII oocytes below 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
9.1. Lupus
9.2. Chronic liver or kidney disease
9.3. Body mass index (BMI) greater than 30
9.4. Uncontrolled hypertension
9.5. Anti-phospholipid antibody
9.6. Thrombophilia
9.7. Insulin dependent diabetes

Recruitment start date

01/11/2010

Recruitment end date

01/11/2011

Locations

Countries of recruitment

Italy

Trial participating centre

GENERA
Rome
00197
Italy

Sponsor information

Organisation

BlueGnome Ltd (UK)

Sponsor details

Breaks House
Mill Court
Great Shelford
Cambridge
CB22 5LD
United Kingdom
+44 (0)1223 844441
info@cambridgebluegnome.com

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

GENERA Centre for Reproductive Medicine (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GENOMA Molecular Genetics Laboratory (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

BlueGnome Ltd (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