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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN37972669

Enrollment

200

Registered

2010-12-20

Start date

2010-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Pregnancy and Childbirth Female infertility

Interventions

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 grou

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026