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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list