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 |
| Secondary identifying numbers | N°GENERA 201003 |
- 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
Scientific
GENERA
Clinica valle Giulia
Via de Notaris 2B
Rome
00197
Italy
| Phone | +39 (0)6 3269791 |
|---|---|
| rienzi@generaroma.it |
Study information
| Study design | Prospective randomised double blinded study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to requset a patient 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 | 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 study start date | 01/11/2010 |
| Completion date | 01/11/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
00197
Italy
Sponsor information
BlueGnome Ltd (UK)
Not defined
Not defined
Breaks House
Mill Court
Great Shelford
Cambridge
CB22 5LD
United Kingdom
| Phone | +44 (0)1223 844441 |
|---|---|
| info@cambridgebluegnome.com | |
"ROR" |
https://ror.org/027c2yv63 |
Funders
Funder type
Research organisation
GENERA Centre for Reproductive Medicine (Italy)
No information available
GENOMA Molecular Genetics Laboratory (Italy)
No information available
BlueGnome Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
