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How science is advancing

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  • 1. How Science is advancing!!
  • 2. N-acetylaysteine (NAC)
    • Mucolytic
    • Recently reported to have insulin senitizing properties
    • Accordingly we used it with C.C to avoid the anti-oestrogenic effect on cervical mucous
  • 3. Observation
    • Improved ovarian response with development of more than one follicle
  • 4. Idea
    • NAC can be a novel combination to CC
  • 5. Clinical Trial
    • The best candidates to this idea are CC resistant cases
  • 6. Keeping in mind
    • NAC has been used safely since long time (Borgstrom et al 1986).
  • 7. Objective
    • to evaluate the effect of NAC adjuvant therapy in women with PCOS resistant to CC.
  • 8. Design
    • prospective RCT,
    • placebo-controlled,
    • double blind
    • Allocation was done using opaque sealed envelopes
  • 9. Patients and Methods
    • Patients:
    • 150 cases diagnosed as CC-resistant PCOS were recruited.
    • Inclusion criteria
    • 1-Normal semen parameters 2-Clomiphene citrate resistant PCOS 3-Normal HSG . 4- No treatment was taken during last 3 ms prior to recruitment.
  • 10. Intervention
    • Participants assigned randomly to receive either
    • 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 .
    • Allocation was done using opaque sealed envelopes
  • 11. Monitoring of the cycle
    • Transvaginal determination of the mean follicular diameter.
    • Measurement of serum E2 levels at time of HCG adminstration.
    • 3. Monitoring intervals were determined by patient response.
  • 12. Then
    • Human chorionic gonadotropin was administered when at least one follicle measured 18 mm
    • Timed intercourse was advised 24-36 hours after hCG injection
  • 13. Success was monitored by
    • A serum progesterone level was checked 6-8 days after the administration of hCG.
    • A serum hCG level was determined 14 days after hCG injection if menses had not yet occurred.
    • Pregnancy was defined as a rise in the serum hCG level on serial determinations at least 2 days apart.
  • 14. Outcomes
    • Primary:
    • Ovulation rate
    • Secondary:
    • pregnancy rate
    • Tolerability
  • 15. Results
    • 150 women with PCO resistant to CC were randomized to
    • CC +NAC: n = 75 (GroupI)
    • CC + placebo: n = 75 (GroupII)
  • 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. 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. Clinical outcomes of both groups
  • 19. Pregnancy rates in patients who received NAC according to their insulin
  • 20. How To Explain
    • Antiapoptotic Odetti et al., 03 .
    • Antioxidant De Mattia et al., 98.
    • Insulin sensitizing effect Fulghesu et al 02.
  • 21. Potential biological activities of NAC
    • Reduces testosterone levels and free androgen index values. Fulghesu et al 02.
    • A safe mucolytic drug.
  • 22. Side effects
    • NAC is generally safe & well tolerated
    • The most common side effects were : 1-Nausea & vomiting. 2-Diarrhea.
    • It is contraindicated in active peptic ulcer disease.
  • 23. Conclusions
    • NAC is a a novel adjuvant treatment for PCOS patients.
    • It is a simple, well tolerated and inexpensive agent.
    • Accepted for publication in Fertil & Steril 2005 Feb
  • 24. STEP II
    • A feasible approach to friendly IVF
  • 25. PILOT STUDY
    • 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”
  • 26. Intervention
    • 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
  • 27. RESULTS
    • 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.
  • 28.
    • 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 .
    • Four women got pregnant (20%) [all were single ton pregnancy). The implantation rate was 14.3%. No miscarriages were reported till now.
  • 29. cost of medications
    • 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,
    • thus the total cost of medications in NAC-CC / ICSI cycle = 45 E.P (7$) which is considerably less than the average cost of medications in the long protocol of ICSI cycle (about 2000EP) (~450$).
  • 30. CONCLUSION II
    • 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 .
  • 31.
    • Thank you