Preimplantation genetic screening (PGS) in women of advanced maternal age

ISRCTN	ISRCTN38014610
DOI	https://doi.org/10.1186/ISRCTN38014610
Protocol serial number	N/A
Sponsor	Serono Nordic AB (Sweden)
Funders	Merck Serono Nordic AB (Sweden), Swedish Research Council (Sweden)

Submission date: 14/01/2008
Registration date: 21/02/2008
Last edited: 11/07/2008

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 Thorir Hardarson
Scientific

Box 5418
Gothenburg
40229
Sweden

Study information

Primary study design	Interventional
Study design	An interventional prospective randomised non-blinded, controlled, two-centre study
Secondary study design	Randomised controlled trial
Scientific title	Preimplantation genetic screening in women of advanced maternal age (AMA) decreased clinical pregnancy rate: a randomised controlled trial
Study objectives	The aim of this randomised study was to investigate whether preimplantation genetic screening (PGS) of embryos on day three would increase the clinical pregnancy rate per randomised patient after in vitro fertilisation (IVF) in women of advanced reproductive maternal age (greater than 38 years).
Ethics approval(s)	Ethics approval received from Goteborg University Ethics Commitee, The Sahlgrenska Academy, on the 14th February 2003 (ref: 610-02).
Health condition(s) or problem(s) studied	Preimplantation genetic screening
Intervention	All the patients went through the same (standardised) IVF treatment including ovarian stimulation with hormonal substitution. Follicular aspiration was performed to retrieve oocytes and the male partner provided a sperm sample. Fertilisation was performed by IVF or ICSI following standard techniques. Thereafter embryos were cultured for three days. On day three (day of randomisation) the embryos were scored and allocated into the control or PGS group. The control group received no further treatment and the patient received their embryo(s) on that day. In the PGS group one cell was biopsied from each embryo and a technique called FISH (fluorescent in-situ hybridisation) was used to determine the number of seven different chromosomes. Only embryos that showed normal chromosomal setup were transferred. The results were followed up firstly by a pregnancy test (day 14 a ET), then an ultrasound (if the patient had not reported a spontaneous abortion) after six to seven weeks. Thereafter the patients went on to the regular health care system and we received (or followed up) information of the last outcome, i.e., delivery or not, the number of children born and if there were any malformations (not an end point in the study).
Intervention type	Other
Primary outcome measure(s)	Clinical pregnancy rate, shown as foetal heart activity per randomised patient, measured six to seven weeks after the transfer of the embryo(s).
Key secondary outcome measure(s)	1. Pregnancy rate per transfer, measured two weeks after the transfer of the embryo(s) 2. Rate of implantation, measured six to seven weeks after the transfer of the embryo(s) 3. Spontaneous abortion and delivery, measured by looking at hospital records throughout the nine months after the transfer of the embryo(s)
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	320
Key inclusion criteria	1. Couples with infertility of female or male origin 2. Intending to undergo IVF or intracytoplasmic sperm injection (ICSI) 3. Signed a written consent form 4. The age of the woman was over 38 years 5. The couple had to have at least three embryos of good morphological quality (GQE). After an amendment, owing to introduction of SET in Sweden in 2003, only two GQE were required. Randomisation, using a data program, was performed on day three.
Key exclusion criteria	Previous enrolment.
Date of first enrolment	01/12/2003
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

Sweden

Study participating centre

Box 5418

Gothenburg
40229
Sweden

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	01/12/2008		Yes	No