RecruitingPhase 1ACTRN12610000064000

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.


Sponsor

IVFAustralia

Enrollment

697 participants

Start Date

Jan 1, 2007

Study Type

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

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a supplemental hormone called recombinant LH (luteinising hormone) to the standard IVF (in vitro fertilisation) process improves the chances of pregnancy in women whose LH levels drop significantly during the treatment cycle. A previous study found that women with a large fall in LH levels had lower pregnancy rates, so this trial will test whether replacing LH improves outcomes. You may be eligible if: - You are under 42 years old - You are undergoing IVF/ICSI using long pituitary down-regulation protocol - This is no more than your third stimulated IVF cycle - You have regular menstrual cycles - You have given your consent to participate You may NOT be eligible if: - You are an egg donor - You failed to achieve adequate suppression of your hormones (down-regulation) within 6 weeks of starting treatment - You have already taken part in this study previously Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 wil

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)

Australia

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ACTRN12610000064000