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.

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.

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000064000

Acronym

IVFA Luveris Trial

Enrollment

697

Registered

2010-01-20

Start date

2007-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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.

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

Outcome results