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InfertilityPhase 3GALANCT02262416

GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles

A Phase 3 study testing leuprolide in people with Infertility, run by Queensland Fertility Group at 1 site in Australia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
leuprolide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
1 siteAustralia
Study dates
Jan 2015to Jan 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 42 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Single embryo transfer
  • Antagonist cycle with HCG trigger
  • Use of progesterone as luteal phase support (crinone or progesterone pessary )
  • Women undergoing their first IVF cycle with TFC
  • Age 18-42 inclusive

Who cannot join

  • No or frozen embryo transfer planned b. Use of other luteal support c. Known contraindication to the use of GnRH analogue

Trial locations and contacts

1 site in 1 country.

Australia1 site
  • Queensland Fertility Group

    Brisbane, Queensland, 4000

Other trials in Australia

About this study

Official title: A Prospective Randomised Controlled Trial of GnRH Agonist and Progesterone Versus Progesterone Only for Luteal Phase Support in Antagonist Cycles

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.

Read the detailed description

In-vitro fertilization has been used since 1978 to treat women with infertility. It involves controlled ovarian stimulation, egg maturation, egg collection, fertilization and embryo culture and finally embryo culture. The luteal phase is the latter phase of the menstrual cycle which begins with the formation of the corpora lutea and ends in either pregnancy or luteolysis. The main hormone associated with this stage is progesterone, which is significantly higher during the luteal phase than other phases of the cycle. In the IVF setting, however, luteal phase deficiency is present and over the last 40 years various regimens have been used to support luteal phase of the cycle. Progesterone is currently widely used for this purpose and has shown to be effective in improving pregnancy and live birth rate (Van der Linden 2011).

There have been various other regimen used for luteal support in an attempt to further enhance luteal phase support such as oestrogen, HCG and GnRH agonist. The recent Cochrane study showed a significant benefit from addition of GnRH agonist to progesterone versus progesterone alone for the outcomes of live birth, clinical pregnancy and ongoing pregnancy. (Van Der Linden 2011) However, the conclusion derived from the metaanalysis were derived from limited number of studies that used various types additional luteal phase support, which also included a myriad of agonist and antagonist IVF cycles. Only ICSI cycles were included in the antagonist cycles.

A gonadotropin-releasing hormone (GnRH) agonist is a synthetic peptide that interacts with the GnRH hormone receptor to elicit its biologic response, the release of the pituitary hormones, FHS and LH. The exact mechanism of how GnRH could potentially increase pregnancy rate is unknown. Tesarik et al performed a randomised study in which addition of GnRH agonist increases implantation rate in donor recipient discounted the theory that GnRH acted on corpora lutea. It is suggested that GnRH acts directly on embryo to secrete BHCG hence enhances implantation. A prospective randomised study that was performed by Isik et al showed a promising result of use of GnRH agonist administration in the luteal phase of GnRH antagonist cycle (n=164). In this study, cases received 0.5mg leuprolide acetate in addition to 600mg micronised progesterone day 6 after ICSI compared to control group who received micronisd progesterone only. The study showed clinical pregnancy rate of 40% in cases vs 20% in control group. The increased number of multiple pregnancies in these studies could be partly explained by multiple embryos transferred. Answer is needed to determine if multiple pregnancy rate is higher if single embryo transfer is executed.

The studies performed by Tesarik et al and Isik et al showed promising increase in live birth rate and clinical pregnancy rates in antagonist cycles. Both studies were performed in clinical settings that were vastly different from Australia: multiple embryos were transferred, multiple luteal phase support were used in addition to progesterone and multiple pregnancy rates were high. Given the significant increase in pregnancy rate (>10%) were observed in these studies, if the increase is real, a RCT in Australia setting is needed prior to implementation of this intervention.

Conditions
Infertility
Being tested
leuprolide
Keywords
GnRH agonist, IVF
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • leuprolideDrug

    Also called lucrin

    normal saline

Study groups in NCT02262416
Study groupRoleWhat they receive
controlsPlacebo comparatorNormal saline of equivalent volume
caseActive comparator0.5mg Leuprolide acetate injection
Receives: Drug: leuprolide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. live birth

    live birth

    Measured: 1 year

  2. on-going pregnancy

    +ve fetal heart rate at nuchal scan

    Measured: 3 months

Secondary outcomes (2)
  1. pregnancy

    positive serum pregnancy test

    Measured: 2 weeks

  2. Ovarian hyperstimulation syndrome

    hospitalisation due to the condition

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02262416
Sponsor's protocol ID
01102014
Acronym
GALA
Status last verified
Oct 2014
First submitted
7 Oct 2014
Last updated
13 Oct 2014
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing leuprolide in people with Infertility, run by Queensland Fertility Group at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

live birth (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02262416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2014.

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