NCT02262416

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 13, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 13, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

October 7, 2014

Last Update Submit

October 10, 2014

Conditions

Infertility

Keywords

GnRH agonistIVF

Outcome Measures

Primary Outcomes (2)

  • live birth

    live birth

    1 year

  • on-going pregnancy

    +ve fetal heart rate at nuchal scan

    3 months

Secondary Outcomes (2)

  • pregnancy

    2 weeks

  • Ovarian hyperstimulation syndrome

    3 months

Study Arms (2)

controls

PLACEBO COMPARATOR

Normal saline of equivalent volume

case

ACTIVE COMPARATOR

0.5mg Leuprolide acetate injection

Drug: leuprolide

Interventions

leuprolideDRUG

normal saline

Also known as: lucrin
case

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queensland Fertility Group

Brisbane, Queensland, 4000, Australia

Location

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 13, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 13, 2014

Record last verified: 2014-10

Locations

AU(1)