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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02262416
Registration number
NCT02262416
Ethics application status
Date submitted
7/10/2014
Date registered
13/10/2014
Date last updated
13/10/2014
Titles & IDs
Public title
GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles
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Scientific title
A Prospective Randomised Controlled Trial of GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles
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Secondary ID [1]
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01102014
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Universal Trial Number (UTN)
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Trial acronym
GALA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infertility
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - leuprolide
Placebo comparator: controls - Normal saline of equivalent volume
Active comparator: case - 0.5mg Leuprolide acetate injection
Treatment: Drugs: leuprolide
normal saline
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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live birth
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Assessment method [1]
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live birth
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Timepoint [1]
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1 year
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Primary outcome [2]
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on-going pregnancy
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Assessment method [2]
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+ve fetal heart rate at nuchal scan
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Timepoint [2]
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3 months
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Secondary outcome [1]
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pregnancy
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Assessment method [1]
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positive serum pregnancy test
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Timepoint [1]
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2 weeks
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Secondary outcome [2]
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Ovarian hyperstimulation syndrome
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Assessment method [2]
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hospitalisation due to the condition
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Timepoint [2]
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3 months
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Eligibility
Key inclusion criteria
1. Single embryo transfer
2. Antagonist cycle with HCG trigger
3. Use of progesterone as luteal phase support (crinone or progesterone pessary )
4. Women undergoing their first IVF cycle with TFC
5. Age 18-42 inclusive
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Minimum age
18
Years
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Maximum age
42
Years
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Sex
Females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
No or frozen embryo transfer planned b. Use of other luteal support c. Known contraindication to the use of GnRH analogue
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2016
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Queensland Fertility Group - Brisbane
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
Queensland Fertility Group
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
In-Vitro Fertilisation (IVF) is the term commonly applied to a form of treatment for infertility that involves controlled ovarian hyperstimulation, egg maturation, egg collection, fertilisation, embryo culture and finally embryo transfer. The period after egg collection is called luteal phase. In Australia, vaginal progesterone is routinely used to support the lining of the uterus so that it is susceptible to implantation of the embryos. More recently, there has been some suggestion that additional supplementation of luteal phase with GnRH agonist increases clinical pregnancy and live birth rate. These studies are however heterogeneous and results were inconsistent. This study is a prospective randomised controlled trial of additional GnRH agonist in luteal phase of antagonist cycle. The primary hypothesis is that GnRH agonist increases the number of live birth . The secondary hypothesis is that this increases the clinical pregnancy rate, on-going pregnancy rate, without affecting the miscarriage rate, ovarian hyperstimulation rate and multiple pregnancy rate.
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Trial website
https://clinicaltrials.gov/study/NCT02262416
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Trial related presentations / publications
Isik AZ, Caglar GS, Sozen E, Akarsu C, Tuncay G, Ozbicer T, Vicdan K. Reprod Biomed Online. 2009 Oct;19(4):472-7. Single-dose GnRH agonist administration in the luteal phase of GnRH antagonist cycles: a prospective randomized study. Medsafe New Zealand. www.medsafe.govt.nz/profs/datasheet/l/Lucrininj.pdf Tarlatzis BC, Bili H.Expert Opin Drug Saf. 2004 Jan;3(1):39-46. Safety of GnRH agonists and antagonists Tesarik J, Hazout A, Mendoza C.Hum Reprod. 2004 May;19(5):1176-80. Enhancement of embryo developmental potential by a single administration of GnRH agonist at the time of implantation Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Hum Reprod. 2006 Oct;21(10):2572-9. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M.Cochrane Database Syst Rev. 2011 Oct 5;(10). Luteal phase support for assisted reproduction cycles
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02262416
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