Condition category
Pregnancy and Childbirth
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
20/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sebastiaan Mastenbroek

ORCID ID

Contact details

Center For Reproductive Medicine
Academic Medical Center
Meibergdreef 9 (A1-229)
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 7524/3090
S.Mastenbroek@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw: 945-03-013; NTR84

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, double blinded, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Ongoing pregnancy rate.

Secondary outcome measures

1. Time to pregnancy
2. Clinical pregnancy rate
3. Pregnancy outcome
4. Implantation rate

Overall trial start date

01/05/2003

Overall trial end date

01/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women between 35 and 41 years of age
2. Undergoing IVF or ICSI

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

372

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/05/2003

Recruitment end date

01/05/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Center For Reproductive Medicine
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Postbus 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/17611204

Publication citations

  1. Results

    Mastenbroek S, Twisk M, van Echten-Arends J, Sikkema-Raddatz B, Korevaar JC, Verhoeve HR, Vogel NE, Arts EG, de Vries JW, Bossuyt PM, Buys CH, Heineman MJ, Repping S, van der Veen F, In vitro fertilization with preimplantation genetic screening., N. Engl. J. Med., 2007, 357, 1, 9-17, doi: 10.1056/NEJMoa067744.

Additional files

Editorial Notes