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Ovulation Induction in The New Millennium

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Ovulation Induction in The New Millennium

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    2. Ovulation Induction in The New Millennium hMG vs recombinant FSH

    3. Introduction Multifollicular development with gonadotropin administration is still an integral component for ovarian stimulation in IVF / ICSI cycles

    4. hMG Recombinant FSH hMG extracted from the urine of menopausal women has been used successfully for many years for ovarian stimulation

    6. Recombinant Insulin & Factor VIII Significant medical benefits in clinical practice have never been convincingly demonstrated for biotech substitutes Zwart-van Rijkom et al,2002

    7. In 1995 5.0 million volume increased by <100% In 2000 26.8million Zwart-van Rijkom et al,2002

    8. Why recFSH was welcomed The concept that LH is redundant and the wish for a more purified product drove the conversion from hMG to recFSH.

    9. Good drug OR Super drug Claimed higher efficacy and bioactivity for recombinant FSH Out et al, 1995 Coelingh Bennink et al, 1997

    10. LH supplementation: is it needed!! Lisi et al., 2001 Filicori et al, 2001 Westergaard et al., 2001 Tesarik and Mendoza, 2002 Commenges-Ducos et al, 2002

    11. Role of Meta-analysis The most widely cited meta-analysis to compare recFSH vs urinary gonadotrophins has focused only on uFSH-P, uFSH-HP Daya& Gunby,1999

    12. Objective To compare recombinant FSH to hMG regarding their clinical efficacy.

    13. Efficacy Should be based upon most up to date evidence RCTs are considered the gold standard Power calculation is essential

    14. Methodology Meta-analysis of: Truly randomized controlled trials IVF/ICSI cycles

    15. Search Strategy MEDLINE EMBASE Cochrane MDSG Specialized Register Hand searching

    16. Primary outcome Live Birth Rate Per Woman (Cochrane handbook, version 8)

    17. Analysis The results were combined for meta-analysis with RevMan software (using the Mantel-Haenszel method). Results were pooled using a fixed-effects model only after confirming that heterogeneity was not present

    18. Results Eight truly RCTs were included in this meta-analysis Janssen 1998 Gordon 2001 Ng 2001 Strehler 2001 Westergaard 2001 Diedrich 2002 Kilani 2003 Balasch 2003

    19. Excluded Trials Balasch et al, 1996 (rFSH vs combined rFSH & hMG) Kornilov et al, 1999 (unclear data) Serhal et al, 2000 (Quasirandomized trial) Mahmoud et al, 2001 (rFSH vs combined rFSH & hMG) Meo et al, 2002 ( retrospective study) Commenges-Ducos et al, 2002 (rFSH vs combined rFSH & hMG) Eskandar et al, 2004 ( not RCT)

    20. Power The sample size of 2105 women is needed to test whether hMG is equivalent or even superior to recombinant FSH in an IVF/ET program. The included trials enrolled 2031 participants

    21. How to interpret the figures! A benefit from recombinant FSH would be displayed graphically to the left of the centre-line. A benefit from hMG would be displayed graphically to the right of the centre-line

    22. Live Birth / Ongoing Pregnancy rate

    23. Clinical pregnancy rate / woman

    24. Significant result with Long Protocol

    25. NNT 23

    26. How To Explain GnRH agonist down-regulation may result in profound suppression of LH concentration, impairing adequate oestradiol synthesis Fleming et al, 2000

    27. LH was shown to improve the implantation rate Gordon et al, 2001 Ganirelix dose-finding study ,1998 Schoolcraft et al, 1999 Identifying which women will require additional LH is costly and unreliable Diedrich et al, 2002

    28. LH is needed The low endogenous LH concentrations achieved with GnRH agonists may amplify the differences in treatment outcomes seen with the use of hMG and recombinant FSH

    29. Miscarriage Rate

    30. Multiple pregnancy rate

    31. OHSS

    32. Economic View

    33. Good drug OR Super drug!!! Claimed higher efficacy and bioactivity of the recombinant FSH Out et al, 1995 Then reduction in amount of recombinant FSH is expected

    34. Significant reduction in Amount of Gonadotrophin (IU)

    35. Further Support Filicori et al, 2003 IUI cases Lloyd et al, 2003 highly purified hMG

    36. How to explain LH activity supplementation enhances FSH activity and optimizes FSH ovulation induction in women undergoing COH for ART procedures

    37. Safety hMG enjoy a safety proven by 30 years of post marketing use, which is the real gold standard for the safety of a pharmaceutical product.

    38. Take Home message The use of hMG is the most cost effective option for ovulation induction in ART programs

    39. Decision makers should establish their choice of one drug over the other based on the most up-to-date available evidence

    40. Thank You

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