Recombinant vs urinary gonadotrophins


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Is there a difference between recombinant and urinary hCG? this talk may help in answering this

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Recombinant vs urinary gonadotrophins

  1. 1. Triggering Ovulation Recombinant Vs Urinary Gonadotrophins
  2. 2. Introduction ♦ LH surge is very important in the final follicular maturation and triggering ovulation. ♦ In addition, the LH surge promotes luteinization forming an active corpus luteum. ♦ These effects of LH are essential for conception to occur
  3. 3. For triggering ♦ urinary hCG has been used for several years to mimic the endogenous LH surge. ♦ Recently recombinant hCG and LH have been introduced . The high purity of this product facilitates subcutaneous injection and hence self-administration
  4. 4. Objective ♦ To investigate the efficacy and safety of (rhCG) or recombinant LH preparation vs (uhCG) for inducing final follicular maturation and triggering ovulation
  5. 5. Types of studies ♦ Only truely randomised controlled trials in which Subfertile couples undergoing triggering ovulation were included
  6. 6. Types of interventions ♦ Recombinant hCG or recombinant LH versus urinary hCG for triggering of ovulation.
  7. 7. Primary outcomes ♦ongoing pregnancy / live birth rate (per woman or per couple)
  8. 8. Secondary outcomes ♦ incidence of ovarian hyperstimulation syndrome (OHSS) ♦ clinical pregnancy rate per cycle ♦ number of oocytes retrieved ♦ miscarriage rate per woman randomised
  9. 9. Search strategy for identification of studies ♦ The Cochrane MDSG Group specialised register ♦ MEDLINE ♦ EMBASE database ♦ Hand searching of abstracts of major international meetings. ♦ Contacting pharmaceutical industries
  10. 10. To assess internal Validity ♦ Was the assigned treatment adequately concealed prior to allocation? ♦ Was an "intention to treat" analysis applied? ♦ Were the outcome assessors blind to assignment status? ♦ Were the treatment and control group comparable at entry? ♦ Were the subjects & treatment providers blind to assignment status following allocation? ♦ Were the withdrawals <10% of the study population
  11. 11. To assess external Validity ♦ Were the inclusion and exclusion criteria for entry clearly defined? ♦ Were the outcome measures used clearly defined? ♦ Were the accuracy and precision of the outcome measures adequate? ♦ Was the timing of the outcome measures appropriate?
  12. 12. Allocation concealment ♦ The quality of allocation concealment was graded as either adequate (A), unclear (B), or inadequate (C).
  13. 13. 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
  14. 14. Results ♦ Fourteen trials were identified and only seven studies were included ♦ Chang et al., 2001, ♦ Driscoll et al, 2000, ♦ The European rHCG Study Group, 2000 ♦ The International rHCG Study Group, 2001 ♦ The European rLH Study Group, 2001, ♦ Manau et al, 2002 ♦ Serono Study 21447
  15. 15. Description of studies ♦ All trials had parallel design with true randomisation using computer generated randomization list ♦ Randomization was done at time of recruitment of participants ♦ All trials were multicenter except Manau , 2002 ♦ All trials were in IVF/ICSI cycles except IRHCG Group, 2001 (O.I) ♦ The methodological quality of the trials was high ♦ All were Double blinded except (Manau & Chang)
  16. 16. R-LH studies ♦ pregnancy rate was found to be significantly lower when the recombinant LH is used for triggering ovulation, ♦ hence, Serono company has decided not to pursue further development and registration of recombinant LH high dose for triggering ovulation.
  17. 17. ♦ Accordingly, The European rLH Study Group, 2001, Manau et al and Serono Study 21447 were excluded from the analysis but kept in the review
  18. 18. Ongoing pregnancy O.R 0.98 [95% C.I 0.69-1.39]
  19. 19. Clinical Pregnancy rate O.R 0.98 [95% C.I 0.71-1.36)
  20. 20. OHSS O.R 1.83 [95% C.I 0.75-4.51)
  21. 21. Miscarriage rate O.R 1.1 [95% C.I 0.52-2.31)
  22. 22. Tolerability ♦ The three, randomized, placebo-controlled, double-blind and double-dummy studies, Driscoll et al, 2000; ERHCG Group, 2000; IRHCG Group, 2001 consistently found a 2- to 3-fold reduction in the incidence of local site reactions. ♦ Chang et al, 2001-an open RCT reported no difference between both drugs.
  23. 23. Implications for practice ♦ There is no difference in clinical outcomes between urinary and recombinant hCG for induction of final follicular maturation and triggering ovulation.
  24. 24. How To Choose ♦ Additional factors should be considered when making the choice, including safety, cost and drug availability.
  25. 25. THANK YOU