Preimplantation genetic screening (PGS) by array-comparative genomic hybridization (CGH) on day 5 embryos with day 6 fresh transfer in repeated implantation failure (RIF) patients

Completed

Conditions: Infertility
Female infertility, unspecified
Urological and Genital Diseases

Registration Number: ISRCTN41698043

Lead Sponsor: BlueGnome Ltd (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 200

Inclusion Criteria

1. Female patients aged 36 years old or younger undergoing an Intra-cytoplasmic sperm injection (ICSI) attempt at GENERA Clinic in Rome
2. History of more than two failed In vitro fertilisation (IVF)/ICSI cycles; without clinical pregnancy with transfer of at least one good quality embryos per transfer
3 .=6 metaphase II (MII) oocytes retrieved
4. Signed consent form

Exclusion Criteria

1. Azoospermic male partner
2. Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml
3. Hydrosalpinx
4. Polycystic ovary syndrome (PCOS)
5. Pre-implantation genetic diagnosis (PGD) cycles [Single Gene Disorders (SGD) or Translocations or other chromosomal abmormalities]
6. Female patients with pathological uterine cavity
7. Number of retrieved MII oocytes < 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 (lupus, chronic liver or kidney disease, body mass index (BMI) >35, uncontrolled hypertension, anti-phospholipid antibody, thrombophilia, insulin dependent diabetes)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ive birth rate [Time Frame: 1 year after embryo transfer]; pregnancies that arrive to term divided by procedures with an egg retrieval

Secondary Outcome Measures

Name	Time	Method
1. Ongoing pregnancy rate per embryo transfer [Time Frame: 20 weeks after embryo transfer]. Ongoing pregnancy defined as the presence of a fetal sac. Pregnancy rate per transfer defined as pregnancies divided by patients with a replacement of embryos.<br>2. Pregnancy rate per retrieval [Time Frame: 20 weeks after embryo transfer]. pregnancy defined as the presence of a fetal sac. Pregnancy rate per retrieval defined as pregnancies divided by patients with an egg retrieval.<br>3. Ongoing pregnancy rate per started cycle [ Time Frame: 20 weeks after embryo transfer ]<br>4. Ongoing implantation rate [Time Frame: 12 weeks after embryo transfer ]<br>5. Number of embryos implanted divided by number of embryos replaced. An embryo implanted is measured as a fetal sac by ultrasound observation.<br>6. Embryo transfer rate per started cycle