Preimplantation genetic screening (PGS) through 24-chromosome aneuploidy screening of day 3 embryos in advanced maternal aged patients: a prospective randomised controlled trial

ISRCTN	ISRCTN37972669
DOI	https://doi.org/10.1186/ISRCTN37972669
Protocol serial number	N°GENERA 201003
Sponsor	BlueGnome Ltd (UK)
Funders	GENERA Centre for Reproductive Medicine (Italy), GENOMA Molecular Genetics Laboratory (Italy), BlueGnome Ltd (UK)

Submission date: 10/11/2010
Registration date: 20/12/2010
Last edited: 20/12/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Laura Rienzi
Scientific

GENERA
Clinica valle Giulia
Via de Notaris 2B
Rome
00197
Italy

Phone	+39 (0)6 3269791
Email	rienzi@generaroma.it

Study information

Primary study design	Interventional
Study design	Prospective randomised double blinded study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PGS by CGH-array on day 3 embryos in AMA patients
Study objectives	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(s)	The local ethics committee (Clinica Valle Giulia, Rome, Italy) approved on the 20th October 2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/11/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/11/2010
Date of final enrolment	01/11/2011

Locations

Countries of recruitment

Italy

Study participating centre

GENERA

Rome
00197
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes