A randomised controlled trial comparing the Gonadotrophin Releasing Hormone agonist long regimen versus the Gonadotrophin Releasing Hormone agonist short regimen versus the Gonadotrophin Releasing Hormone antagonist regimen in poor responders undergoing in vitro fertilisation treatment
| ISRCTN | ISRCTN27044628 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27044628 |
| EudraCT/CTIS number | 2006-004460-31 |
| Secondary identifying numbers | EudraCT No 2006-004460-31 |
- Submission date
- 01/09/2006
- Registration date
- 27/10/2006
- Last edited
- 05/11/2013
- 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
Mr Yakoub Khalaf
Scientific
Scientific
Assisted Conception Unit
4th Floor Thomas Guy House
Guy's Hospital
London
SE1 9RT
United Kingdom
| Phone | +44 (0)20 7188 0501 |
|---|---|
| yakoub.khalaf@kcl.ac.uk |
Study information
| Study design | Prospective, concealed, single-blind, three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | PRINT (Poor Responders INtervention Trial) |
| Study objectives | Different interventions have been proposed to improve response to ovarian stimulation in poor responders. These include various interventions for downregulation, ovarian stimulation and adjuvant therapies. Following review and analysis of existing evidence for downregulation regimens we were not able to ascertain which the best down regulation regimen is for poor responders in In Vitro Fertilisation (IVF) treatment. We, therefore, propose a randomised trial to answer this question. There is however lack of evidence to show that any one intervention improves outcome significantly. The purpose of this study is to compare the three most commonly used regimens in IVF treatment and find out whether any one regimen is significantly better. |
| Ethics approval(s) | Ethics approval pending as of 27/10/2006. |
| Health condition(s) or problem(s) studied | Poor ovarian response in In Vitro Fertilisation (IVF) |
| Intervention | Each intervention group will be receiving one of the following treatments: 1. The Gonadotrophin Releasing Hormone (GnRH) agonist long regimen 2. The GnRH agonist short regimen 3. The GnRH antagonist regimen |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Gonadotrophin Releasing Hormone (GnRH) agonist long regimen, GnRH agonist short regimen and GnRH antagonist regimen. |
| Primary outcome measure | Number of oocytes retrieved at egg collection |
| Secondary outcome measures | 1. Total FSH dose used for ovarian stimulation 2. Number of mature oocytes retrieved 3. Number of embryos available for transfer 4. Clinical pregnancies (ultrasound evidence of foetal heart at eight weeks gestation) |
| Overall study start date | 01/11/2006 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 34 participants in each arm giving a total of 102 participants |
| Key inclusion criteria | Any woman undergoing an IVF treatment cycle with or without Intra Cytoplasmic Sperm Injection (ICSI) who is considered to be a "poor responder" is eligible to participate in the trial. For this study a "poor responder" is defined as a woman who had a previous IVF treatment cycle in which she was stimulated with a daily dose of Follicle Stimulating Hormone (FSH) of 300 IU or more for at least nine days and: 1. Produced an inadequate number of mature follicles (three or less follicles measuring more than or equal to 17 mm, or 2. Had three or less oocytes retrieved at oocyte retrieval |
| Key exclusion criteria | 1. Women aged more than 40 years 2. Women with a single ovary |
| Date of first enrolment | 01/11/2006 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Assisted Conception Unit
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's and St Thomas' NHS Foundation Trust and King' s College London (UK)
Hospital/treatment centre
Hospital/treatment centre
Guy's Hospital
St Thomas' Street
London
SE1 9RT
England
United Kingdom
| Website | http://www.guysandstthomas.nhs.uk/home.aspx |
|---|---|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Hospital/treatment centre
Assisted Conception Unit, Guy's and St Thomas' NHS Foundation Trust (UK)
No information available
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 | 28/12/2007 | Yes | No |
