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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Study type
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

Primary outcome [1] 0 0
live birth - live birth
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
on-going pregnancy - +ve fetal heart rate at nuchal scan
Timepoint [2] 0 0
3 months
Secondary outcome [1] 0 0
pregnancy - positive serum pregnancy test
Timepoint [1] 0 0
2 weeks
Secondary outcome [2] 0 0
Ovarian hyperstimulation syndrome - hospitalisation due to the condition
Timepoint [2] 0 0
3 months

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
Can healthy volunteers participate?
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
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 3
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Queensland Fertility Group

Ethics approval
Ethics application status

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
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. 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

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