How Science is advancing!!
N-acetylaysteine (NAC) <ul><li>Mucolytic  </li></ul><ul><li>Recently reported to have insulin senitizing properties </li><...
Observation <ul><li>Improved ovarian response with development of more than one follicle </li></ul>
Idea <ul><li>NAC can be a novel combination to CC </li></ul>
Clinical Trial <ul><li>The best candidates to this idea are CC resistant cases </li></ul>
Keeping in mind <ul><li>NAC has  been used safely since long time  (Borgstrom et al 1986). </li></ul>
Objective <ul><li>to evaluate the effect of NAC adjuvant therapy in women with PCOS resistant to CC. </li></ul>
Design <ul><li>prospective RCT, </li></ul><ul><li>placebo-controlled, </li></ul><ul><li>double blind  </li></ul><ul><li>Al...
Patients and Methods <ul><li>Patients: </li></ul><ul><li>150 cases diagnosed as CC-resistant PCOS  were recruited. </li></...
Intervention <ul><li>Participants assigned randomly to receive either </li></ul><ul><li>NAC 600 mg / twice daily  ( group ...
Monitoring of the cycle  <ul><li>Transvaginal determination of the mean follicular diameter. </li></ul><ul><li>Measurement...
Then <ul><li>Human chorionic gonadotropin was administered when at least one follicle measured 18 mm </li></ul><ul><li>Tim...
Success was monitored by <ul><li>A serum progesterone level was checked 6-8 days after the administration of hCG.  </li></...
Outcomes <ul><li>Primary: </li></ul><ul><li>Ovulation rate </li></ul><ul><li>Secondary: </li></ul><ul><li>pregnancy rate <...
Results <ul><li>150 women with PCO resistant to CC were randomized to  </li></ul><ul><li>CC +NAC: n = 75  (GroupI) </li></...
Demographics NS 28.5 ± 5.7  30.5 ± 2.6  BMI NS 99.2 ± 12.3  101.3  ± 12.4  B WT (Kg) NS 4.4 ± 2.6  5.0  ± 2.9  Duration (Y...
Hormonal profile NS 85.9 ± 14.1  81.9 ± 12  Fasting Glucose (mg/dL)  NS 17.2 ± 4.4  18.8  ± 4.7  Fasting insulin (U/mL)  N...
Clinical outcomes of both groups
Pregnancy rates in patients who received NAC according to their insulin
How To Explain <ul><li>Antiapoptotic  Odetti et al., 03 . </li></ul><ul><li>Antioxidant  De Mattia et al., 98. </li></ul><...
Potential biological activities of NAC <ul><li>Reduces testosterone levels and free androgen index values.  Fulghesu et al...
Side effects <ul><li>NAC is generally safe & well tolerated </li></ul><ul><li>The most common side effects were : 1-Nausea...
Conclusions <ul><li>NAC  is a   a novel adjuvant treatment for PCOS patients. </li></ul><ul><li>It is a simple, well toler...
STEP II <ul><li>A feasible approach to friendly IVF </li></ul>
PILOT STUDY <ul><li>The objective of this study was to examine the use of NAC with clomiphene citrate for ovarian stimulat...
Intervention   <ul><li>Patients were offered NAC, 1,200 mg/day from day 3-7 of the menstrual cycle with CC (100 mg /day) s...
RESULTS <ul><li>Twenty women were enrolled in this pilot study with a mean age of 27.3 ± 1.9 and mean BMI of 28.1 ± 0.8.  ...
<ul><li>The mean number of follicles >18 mm on the day of HCG injection was 4.8 ± 1.6. The mean number of oocytes retrieve...
cost of medications <ul><li>the number of NAC sachets used was 6 per day for 5 days making a total of 30 costing 27 E.P pl...
CONCLUSION II <ul><li>a simple NAC-CC protocol is compatible with the concept of `friendly IVF', yielding a reasonable pre...
<ul><li>Thank you </li></ul>
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How science is advancing

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How science is advancing

  1. 1. How Science is advancing!!
  2. 2. N-acetylaysteine (NAC) <ul><li>Mucolytic </li></ul><ul><li>Recently reported to have insulin senitizing properties </li></ul><ul><li>Accordingly we used it with C.C to avoid the anti-oestrogenic effect on cervical mucous </li></ul>
  3. 3. Observation <ul><li>Improved ovarian response with development of more than one follicle </li></ul>
  4. 4. Idea <ul><li>NAC can be a novel combination to CC </li></ul>
  5. 5. Clinical Trial <ul><li>The best candidates to this idea are CC resistant cases </li></ul>
  6. 6. Keeping in mind <ul><li>NAC has been used safely since long time (Borgstrom et al 1986). </li></ul>
  7. 7. Objective <ul><li>to evaluate the effect of NAC adjuvant therapy in women with PCOS resistant to CC. </li></ul>
  8. 8. Design <ul><li>prospective RCT, </li></ul><ul><li>placebo-controlled, </li></ul><ul><li>double blind </li></ul><ul><li>Allocation was done using opaque sealed envelopes </li></ul>
  9. 9. Patients and Methods <ul><li>Patients: </li></ul><ul><li>150 cases diagnosed as CC-resistant PCOS were recruited. </li></ul><ul><li>Inclusion criteria </li></ul><ul><li>1-Normal semen parameters 2-Clomiphene citrate resistant PCOS 3-Normal HSG . 4- No treatment was taken during last 3 ms prior to recruitment. </li></ul>
  10. 10. Intervention <ul><li>Participants assigned randomly to receive either </li></ul><ul><li>NAC 600 mg / twice daily ( group I ) with CC 50 mg / twice daily or placebo ( group II ) with CC 50 mg / twice daily for 5 days starting at day 3 of the cycle . </li></ul><ul><li>Allocation was done using opaque sealed envelopes </li></ul>
  11. 11. Monitoring of the cycle <ul><li>Transvaginal determination of the mean follicular diameter. </li></ul><ul><li>Measurement of serum E2 levels at time of HCG adminstration. </li></ul><ul><li>3. Monitoring intervals were determined by patient response. </li></ul>
  12. 12. Then <ul><li>Human chorionic gonadotropin was administered when at least one follicle measured 18 mm </li></ul><ul><li>Timed intercourse was advised 24-36 hours after hCG injection </li></ul>
  13. 13. Success was monitored by <ul><li>A serum progesterone level was checked 6-8 days after the administration of hCG. </li></ul><ul><li>A serum hCG level was determined 14 days after hCG injection if menses had not yet occurred. </li></ul><ul><li>Pregnancy was defined as a rise in the serum hCG level on serial determinations at least 2 days apart. </li></ul>
  14. 14. Outcomes <ul><li>Primary: </li></ul><ul><li>Ovulation rate </li></ul><ul><li>Secondary: </li></ul><ul><li>pregnancy rate </li></ul><ul><li>Tolerability </li></ul>
  15. 15. Results <ul><li>150 women with PCO resistant to CC were randomized to </li></ul><ul><li>CC +NAC: n = 75 (GroupI) </li></ul><ul><li>CC + placebo: n = 75 (GroupII) </li></ul>
  16. 16. Demographics NS 28.5 ± 5.7 30.5 ± 2.6 BMI NS 99.2 ± 12.3 101.3 ± 12.4 B WT (Kg) NS 4.4 ± 2.6 5.0 ± 2.9 Duration (Ys) NS 28.4 ± 5.7 28.9 ± 4.7 Age (Ys) P value Group II Group I Variable
  17. 17. Hormonal profile NS 85.9 ± 14.1 81.9 ± 12 Fasting Glucose (mg/dL) NS 17.2 ± 4.4 18.8 ± 4.7 Fasting insulin (U/mL) NS 2.1 2.2 LH/FSH ratio P value Group II Group I Variable
  18. 18. Clinical outcomes of both groups
  19. 19. Pregnancy rates in patients who received NAC according to their insulin
  20. 20. How To Explain <ul><li>Antiapoptotic Odetti et al., 03 . </li></ul><ul><li>Antioxidant De Mattia et al., 98. </li></ul><ul><li>Insulin sensitizing effect Fulghesu et al 02. </li></ul>
  21. 21. Potential biological activities of NAC <ul><li>Reduces testosterone levels and free androgen index values. Fulghesu et al 02. </li></ul><ul><li>A safe mucolytic drug. </li></ul>
  22. 22. Side effects <ul><li>NAC is generally safe & well tolerated </li></ul><ul><li>The most common side effects were : 1-Nausea & vomiting. 2-Diarrhea. </li></ul><ul><li>It is contraindicated in active peptic ulcer disease. </li></ul>
  23. 23. Conclusions <ul><li>NAC is a a novel adjuvant treatment for PCOS patients. </li></ul><ul><li>It is a simple, well tolerated and inexpensive agent. </li></ul><ul><li>Accepted for publication in Fertil & Steril 2005 Feb </li></ul>
  24. 24. STEP II <ul><li>A feasible approach to friendly IVF </li></ul>
  25. 25. PILOT STUDY <ul><li>The objective of this study was to examine the use of NAC with clomiphene citrate for ovarian stimulation in assisted conception as a model for “Friendly IVF” </li></ul>
  26. 26. Intervention <ul><li>Patients were offered NAC, 1,200 mg/day from day 3-7 of the menstrual cycle with CC (100 mg /day) starting on day 3-7. HCG (10,000 IU) was given when leading follicle(s) were  18mm followed by ICSI </li></ul>
  27. 27. RESULTS <ul><li>Twenty women were enrolled in this pilot study with a mean age of 27.3 ± 1.9 and mean BMI of 28.1 ± 0.8. </li></ul>
  28. 28. <ul><li>The mean number of follicles >18 mm on the day of HCG injection was 4.8 ± 1.6. The mean number of oocytes retrieved was 3.6±1.2 . </li></ul><ul><li>Four women got pregnant (20%) [all were single ton pregnancy). The implantation rate was 14.3%. No miscarriages were reported till now. </li></ul>
  29. 29. cost of medications <ul><li>the number of NAC sachets used was 6 per day for 5 days making a total of 30 costing 27 E.P plus an average of two fillings of clomid = 18 EP, </li></ul><ul><li>thus the total cost of medications in NAC-CC / ICSI cycle = 45 E.P (7$) which is considerably less than the average cost of medications in the long protocol of ICSI cycle (about 2000EP) (~450$). </li></ul>
  30. 30. CONCLUSION II <ul><li>a simple NAC-CC protocol is compatible with the concept of `friendly IVF', yielding a reasonable pregnancy rate per cycle started. The results of this study should be substantiated in a larger cohort of patients . </li></ul>
  31. 31. <ul><li>Thank you </li></ul>

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