Condition category
Pregnancy and Childbirth
Date applied
14/01/2008
Date assigned
21/02/2008
Last edited
11/07/2008
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 Thorir Hardarson

ORCID ID

Contact details

Box 5418
Gothenburg
40229
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Preimplantation genetic screening in women of advanced maternal age (AMA) decreased clinical pregnancy rate: a randomised controlled trial

Acronym

Study hypothesis

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

Ethics approval received from Goteborg University Ethics Commitee, The Sahlgrenska Academy, on the 14th February 2003 (ref: 610-02).

Study design

An interventional prospective randomised non-blinded, controlled, two-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Clinical pregnancy rate, shown as foetal heart activity per randomised patient, measured six to seven weeks after the transfer of the embryo(s).

Secondary outcome measures

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)

Overall trial start date

01/12/2003

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

320

Participant exclusion criteria

Previous enrolment.

Recruitment start date

01/12/2003

Recruitment end date

30/11/2006

Locations

Countries of recruitment

Sweden

Trial participating centre

Box 5418
Gothenburg
40229
Sweden

Sponsor information

Organisation

Serono Nordic AB (Sweden)

Sponsor details

Frösundaviks Allé 1
Solna
19670
Sweden

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Merck Serono Nordic AB (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Swedish Research Council (Sweden)

Alternative name(s)

Swedish Research Council, VR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

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/18583331

Publication citations

  1. Results

    Hardarson T, Hanson C, Lundin K, Hillensjö T, Nilsson L, Stevic J, Reismer E, Borg K, Wikland M, Bergh C, Preimplantation genetic screening in women of advanced maternal age caused a decrease in clinical pregnancy rate: a randomized controlled trial., Hum. Reprod., 2008, 23, 12, 2806-2812, doi: 10.1093/humrep/den217.

Additional files

Editorial Notes