Condition category
Pregnancy and Childbirth
Date applied
01/09/2006
Date assigned
27/10/2006
Last edited
05/11/2013
Prospective/Retrospective
Prospectively 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

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 measures

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

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

http://www.guysandstthomas.nhs.uk/home.aspx

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

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18163902

Publication citations

  1. 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.

Additional files

Editorial Notes