Preimplantation genetic screening (PGS) through 24-chromosome aneuploidy screening of day 3 embryos in advanced maternal aged patients: a prospective randomised controlled trial
- Conditions
- InfertilityPregnancy and ChildbirthFemale infertility
- Registration Number
- ISRCTN37972669
- Lead Sponsor
- BlueGnome Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 200
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ongoing pregnancy rate per embryo transfer (defined as the ratio between the number of <br>ongoing prergnancy greater than 20 weeks gestation and the number of embryo transfer performed)
- Secondary Outcome Measures
Name Time Method 1. Embryo transfer rate per started cycle<br>2. Ongoing implantation rate<br>3. Miscarriage rate<br>4. Multiple pregnancy rate<br>5. Ongoing pregnancy rate per started cycle