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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
A Prospective Randomised Controlled Trial of GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles
Secondary ID [1] 0 0
01102014
Universal Trial Number (UTN)
Trial acronym
GALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
live birth
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
on-going pregnancy
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
pregnancy
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Ovarian hyperstimulation syndrome
Timepoint [2] 0 0
3 months

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
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No or frozen embryo transfer planned b. Use of other luteal support c. Known
contraindication to the use of GnRH analogue

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2016
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Queensland Fertility Group - Brisbane
Recruitment postcode(s) [1] 0 0
4000 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Queensland Fertility Group
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02262416
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
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02262416