Contact information
Type
Scientific
Primary contact
Mr Yakoub Khalaf
ORCID ID
Contact details
Assisted Conception Unit
4th Floor Thomas Guy House
Guy's Hospital
London
SE1 9RT
United Kingdom
+44 (0)20 7188 0501
yakoub.khalaf@kcl.ac.uk
Additional identifiers
EudraCT number
2006-004460-31
ClinicalTrials.gov number
Protocol/serial number
EudraCT No 2006-004460-31
Study information
Scientific title
Acronym
PRINT (Poor Responders INtervention Trial)
Study hypothesis
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
Ethics approval pending as of 27/10/2006.
Study design
Prospective, concealed, single-blind, three-arm randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
01/11/2006
Overall trial end date
01/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
34 participants in each arm giving a total of 102 participants
Participant exclusion criteria
1. Women aged more than 40 years
2. Women with a single ovary
Recruitment start date
01/11/2006
Recruitment end date
01/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Assisted Conception Unit
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas' NHS Foundation Trust and King' s College London (UK)
Sponsor details
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Assisted Conception Unit, Guy's and St Thomas' NHS Foundation Trust (UK)
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
Basic results (scientific)
Publication list
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18163902
Publication citations
-
Results
Sunkara SK, Coomarasamy A, Khalaf Y, Braude P, A three-arm randomised controlled trial comparing Gonadotrophin Releasing Hormone (GnRH) agonist long regimen versus GnRH agonist short regimen versus GnRH antagonist regimen in women with a history of poor ovarian response undergoing in vitro fertilisation (IVF) treatment: Poor responders intervention trial (PRINT)., Reprod Health, 2007, 4, 12, doi: 10.1186/1742-4755-4-12.