Preimplantation genetic screening for aneuploidies in patients with advanced maternal age undergoing in vitro fertilisation
| ISRCTN | ISRCTN76355836 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76355836 |
| Protocol serial number | ZonMw: 945-03-013; NTR84 |
| Sponsor | Academic Medical Center (AMC) (The Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 12/09/2005
- Registration date
- 12/09/2005
- Last edited
- 20/10/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sebastiaan Mastenbroek
Scientific
Scientific
Center For Reproductive Medicine
Academic Medical Center
Meibergdreef 9 (A1-229)
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 7524/3090 |
|---|---|
| S.Mastenbroek@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group, double blinded, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine whether in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) combined with preimplantation genetic screening (PGS) in patients with advanced maternal age, i.e. women between 35 and 41 years of age, is a cost-effective alternative compared to IVF/ICSI without PGS. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Subfertility, infertility |
| Intervention | Patients are allocated at random to one of two treatment arms: 1. IVF/ICSI with PGS (selection of embryos based on normal number of studied chromosomes), or 2. IVF/ICSI without PGS (selection of embryos based on morphology). A maximum of two embryos will be transferred, according to the European Society of Human Reproduction and Embryology (ESHRE)-guidelines. In both treatment arms three treatment-cycles will be offered. |
| Intervention type | Other |
| Primary outcome measure(s) |
Ongoing pregnancy rate. |
| Key secondary outcome measure(s) |
1. Time to pregnancy |
| Completion date | 01/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 372 |
| Key inclusion criteria | 1. Women between 35 and 41 years of age 2. Undergoing IVF or ICSI |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/05/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Center For Reproductive Medicine
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
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? |
|---|---|---|---|---|---|
| Results article | Results | 05/07/2007 | Yes | No |
