Preimplantation genetic screening (PGS) in women of advanced maternal age
| ISRCTN | ISRCTN38014610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38014610 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Box 5418
Gothenburg
40229
Sweden
Study information
| Study design | An interventional prospective randomised non-blinded, controlled, two-centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/12/2003 |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
40229
Sweden
Sponsor information
Serono Nordic AB (Sweden)
Industry
Industry
Frösundaviks Allé 1
Solna
19670
Sweden
"ROR" |
https://ror.org/01vp49361 |
|---|
Funders
Funder type
Industry
Merck Serono Nordic AB (Sweden)
No information available
Swedish Research Council (Sweden)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Swedish Research Council, VR
- Location
- Sweden
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
