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.
IVFAustralia
697 participants
Jan 1, 2007
Interventional
Conditions
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
Eligibility
Inclusion Criteria5
- IVF/ICSI using long pituitary down regulation.
- No more than 3 stimulated IVF/ICSI treatment cycles before.
- Not reached 42nd birthday.
- Consent to undergo study.
- Regular menstrual cycle.
Exclusion Criteria3
- Oocyte donors.
- Failure to achieve down regulation within 6 weeks of starting gonadotrophin releasing hormone agonist (GnRH a), are to be excluded for the study.
- Patients who have already taken part in the study
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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.
Locations(1)
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ACTRN12610000064000