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Trial registered on ANZCTR


Registration number
ACTRN12610000064000
Ethics application status
Approved
Date submitted
23/03/2007
Date registered
20/01/2010
Date last updated
20/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective Randomised Controlled Trial assessing recombinant Luteinising Hormone supplementation in patients with a relative reduction in Luteinising Hormone (LH) levels during Vitro Fertilisation/Intracytoplasmic sperm Injection (IVF/ICSI) treatment.
Scientific title
A prospective Randomised Controlled Trial assessing recombinant LH supplementation in patients with a relative reduction in Luteinising Hormone (LH) levels during In Vitro Fertilisation/Intracytoplasmic sperm Injection (IVF/ICSI) treatment.
Universal Trial Number (UTN)
Trial acronym
IVFA Luveris Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility treated with IVF 2136 0
Low serum LH levels during IVF treatment cycles. 252328 0
Condition category
Condition code
Reproductive Health and Childbirth 2232 2232 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recombinant "LH" Luteinising Hormone (Luveris), after 6 days of "FSH" follicle stimulating hormoneadministration during IVF treatment.
The group randomised into LH (Luteinising Hormone) treatment will receive recombinant LH at a dose of 75IU daily from day 7 of FSH (the day after randomisation) to the trigger injection, which on average will be 5 to 6 days. The treatement group will also receive the standard FSH daily dose. The non-treatment group receives the standrd FSH (which will differ on a case by case basis, based on age and ovarian reserve) injections only (again this will be for an average of 5-6 days). The is a third group in which the serum LH levels are normal. They are not randomised and act as a comparator and will receive standard FSH treatment. Hence no one will have any standard treatment withdrwn.
Intervention code [1] 1666 0
Treatment: Drugs
Comparator / control treatment
The answer is standard FSH treatment.
Control group
Active

Outcomes
Primary outcome [1] 3093 0
Clinical Pregnancy Rate
Timepoint [1] 3093 0
at about 6 to 8 weeks gestation. defined as a fetal geart beat on ultrasound.
Secondary outcome [1] 5176 0
1) Live-birth Rate
Timepoint [1] 5176 0
at the end of the study
Secondary outcome [2] 5177 0
2) Serum LH levels
Timepoint [2] 5177 0
On day 0 and day 6 (pmol/L)
Secondary outcome [3] 5178 0
3) Total amount of FSH used (IU)
Timepoint [3] 5178 0
at the end of the trial
Secondary outcome [4] 5179 0
4) Days of controlled ovarian hyperstimulation.
Timepoint [4] 5179 0
from start of FSH to day of HCG (human chorionic gonadotrophin)
Secondary outcome [5] 5180 0
5) Maximal serum estradiol concentration (pmol/L)
Timepoint [5] 5180 0
during FSH stimmulation
Secondary outcome [6] 5181 0
6) Mid follicular and final serum progesterone concentration (pmol/L)
Timepoint [6] 5181 0
day 6 of FSH stimmulation and on day of HCG (human chorionic gonadotrophin) or day before
Secondary outcome [7] 5182 0
7) Number of oocytes collected
Timepoint [7] 5182 0
day of egg pick-up
Secondary outcome [8] 5183 0
8) Number of usable embryos (embryos suitable for fresh transfer or cryopreservation).
Timepoint [8] 5183 0
determined on day 6 post egg pick-up
Secondary outcome [9] 5184 0
9) Embryo development to the blastocyst stage (blastocyst scoring as per Gardiner D.).
Timepoint [9] 5184 0
6 days following egg pick-up
Secondary outcome [10] 5185 0
10) Miscarriage Rate (fetal loss < 20 weeks after gest sac on ultrasound).
Timepoint [10] 5185 0
within 20 weeks
Secondary outcome [11] 5186 0
11) Side effects observed: Ovarian hyperstimulation syndrome (OHSS)- clinical diagnosis usually based on hospitalisation. Drug reactions such as allergies, diagnosed clinically and registeres on our data base.
Timepoint [11] 5186 0
during IVF cycle and following month

Eligibility
Key inclusion criteria
1) IVF/ICSI using long pituitary down regulation.
2) No more than 3 stimulated IVF/ICSI treatment cycles before.
3) Not reached 42nd birthday.
4) Consent to undergo study.
5) Regular menstrual cycle.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Oocyte donors.
2) Failure to achieve down regulation within 6 weeks of starting gonadotrophin releasing hormone agonist (GnRH a), are to be excluded for the study.
3) Patients who have already taken part in the study

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)
Subjects are enrolled prior to IVF. If they experience a 50% or greater reduction in LH levels they are randomized into treatment or control. The randomisation is computer generated and web based. The subjects were unaware of which group they would be enrolled in. Allocation was determined by central computer randomisation. Allocation was thus concealled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer genrated (soft ware)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
697
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2392 0
Commercial sector/Industry
Name [1] 2392 0
IVFAustralia
Country [1] 2392 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
IVFAustralia
Address
176 Pcific Hwy

Greenwich 2065 NSW

Australia
Country
Australia
Secondary sponsor category [1] 251518 0
None
Name [1] 251518 0
Address [1] 251518 0
Country [1] 251518 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4219 0
IVFAustralia
Ethics committee address [1] 4219 0
Ethics committee country [1] 4219 0
Australia
Date submitted for ethics approval [1] 4219 0
Approval date [1] 4219 0
Ethics approval number [1] 4219 0

Summary
Brief summary
Primary Aim: To assess the effect of recombinant LH (rLH) use in patients undergoing IVF/ICSI who experience a 50% or more reduction in serum LH concentrations from the early to mid follicular phase.
IVFAustralia has performed a retrospective pilot cohort study, which in 701 cycles of IVF/ICSI revealed that a reduction 50% or greater from early to mid-follicular LH concentrations resulted in significant reduction in live-birth rate (Lahoud et. al., 2006).
Research Design:Prospective Randomised Controlled Trial
Study population: Patients undergoing IVF/ICSI treatment at IVFAusralia.
Intervention: The treatment group will receive 75 IU of rLH (Luveris) from day 7 of FSH administration until and including the day of HCG administration.
Primary outcome: Clinical Pregnancy Rate
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27769 0
Address 27769 0
Country 27769 0
Phone 27769 0
Fax 27769 0
Email 27769 0
Contact person for public queries
Name 10855 0
Dr Robert Lahoud
Address 10855 0
176 Pcific Hwy

Greenwich 2065, NSW

Australia
Country 10855 0
Australia
Phone 10855 0
+61 414787795
Fax 10855 0
+61 2 94251600
Email 10855 0
[email protected]
Contact person for scientific queries
Name 1783 0
Dr Robert Lahoud
Address 1783 0
176 Pcific Hwy

Greenwich 2065, NSW

Australia
Country 1783 0
Australia
Phone 1783 0
+61 414787795
Fax 1783 0
+61 2 94251600
Email 1783 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRecombinant LH supplementation in patients with a relative reduction in LH levels during IVF/ICSI cycles: A prospective randomized controlled trial.2017https://dx.doi.org/10.1016/j.ejogrb.2017.01.011
N.B. These documents automatically identified may not have been verified by the study sponsor.