2. 1 NaProTechnology ® A Family Physician’s Protocol Dr. Phil Boyle MICGP MRCGP CNFPMC Toronto July ‘03

3. 2 Fertility Care TM Taking Care of your fertility NaProTechnology® A New Reproductive Science that works by co-operating with the natural procreative cycle

4. 3 NaProTechnology ® s Physiology before Pathology s A Disease Based approach to infertility s If not……….why not?

5. 4 IVF- Diagnosis before Treatment 42% Unexplained

6. 5 NaProTechnology ® s Consistent with accepted medical principles –History (standardised medical form) –Symptoms –Signs –Investigations –Diagnosis –Targeted Medical / Surgical Treatment

7. 6 The FertilityCare TM System ( History ) s Unable to conceive s Previous miscarriage s Previous Ectopic Pregnancy s Prematurity s Low Birth Weight s Placental Abruption s Pregnancy induced Hypertension (Not PET)

8. 7 The FertilityCare TM System (Symptoms) s Premenstrual Tension u lasting for 5 days or more u relieved with menses s Record Average u Symptoms, u Days, u Duration, u Severity out of 10

9. 8 The FertilityCare Chart (Clinical Signs) s Dry Cycles s Limited Mucus s Premenstrual Spotting s Intermenstrual spotting s Tail-end brown bleeding s Short luteal phase s Long luteal phase s Long cycles

10. 9 Targeted Hormone Evaluation Investigation Level 1.

11. 10 Targeted Hormone Evaluation (Investigation Level 1.) s Peak Plus 7 Progesterone (18.5 - 31.0 ng/dl) (60 - 100 nmol/L) Oestradiol (145 – 300 pg/l) (400 – 800 pmol/l) s Peak Plus 3,5,7,9,11 s Pre Peak P-3, P-1, P+1 Oestradiol only - Over 370 pg/l (1000 nmol/l)

12. 11 Ultrasound Studies (Investigation Level 2.) s Structural Assessment –Uterus - Fibroids, Polyps, Retroverted –Tubes - Hydrosalpinx –Ovaries - Cysts, Endometrioma

13. 12 Ultrasound Studies (Investigation Level 2.) s Follicular Tracking

14. 13 Ultrasound Studies (Investigation Level 2.) s Follicular Tracking u Small Follicles u Incomplete (Partial) Rupture u Luteinised Unruptured Follicle u Normal Rupture u Endometrial Response

15. 14 Surgical Evaluation (Investigation Level 3.) s Lap and Dye s Hysteroscopy s Transcervical Catheterisation of Fallopian Tube. USA s Laparotomy and Microsurgery

16. 15 DiagnosisFUNCTIONAL s Hormone deficiency - Follicular or Luteal? s Ovulatory defect - Anovulation, Luteinised Unruptured Follicle Syndrome, Partial follicular rupture. s Limited cervical Mucus Flow s Male FactorSTRUCTURAL s Surgical - Endometriosis, PCOD, Fibroids, Polyp, Uterine Septum, PID.

17. 16 TreatmentFUNCTIONAL s Luteal Phase Support - HCG, Progesterone s Mucus Enhancers - Vitamin B6, Mucolytics, Antibiotics s Stress Management s Male Treatment s Ovulation Induction - Clomiphene, HCG, FSH, GnRHSTRUCTURAL s Surgical - Endometriosis, Ovarian Diathermy, Fibroids, Polyp, Uterine Septum, PID. AIM is to restore normal Function over 12 effective cycles

18. 17 NaProTechnology Co-operates with the couple’s natural procreative potential to achieve optimum function. s Creighton Model FertilityCare TM System s Medical Treatments s Surgical Treatments s Counselling - Stress Management s Spiritual Support - prayer for couples

19. 18 s The FertilityCare TM system is the cornerstone to evaluation and treatment with NaProTechnology® s Everything is built on or around the fertility chart The Creighton Model FertilityCare TM System

20. 19 s Charting abnormalities are just the tip of a very large patho-physiologic iceberg! The Creighton Model FertilityCare TM System

21. 20 Are associated with: u Hypothalamic-pituitary-gonadal Dysfunction u Poor Follicular Function u Abnormal levels of Oestradiol 17 Beta, Progesterone u Endometriosis u Pelvic Adhesions u Polycystic Ovaries Charting abnormalities

22. 21 Not Suitable s Established Menopause s Zero Sperm count / Motility s Completely Blocked Fallopian Tubes despite surgical reconstruction

23. 22 Creighton Model NaProTracking s Important for the initial evaluation s Timing of Hormone Blood Tests s To Monitor the response to treatment - cycle by cycle u Mucus u Hormones u Timing for Intercourse u Effects of stress

24. 23 Infertility Protocol -Family Physician s Initial Medical Consultation s NaProTracking for 2 cycles s Blood Tests & Seminal fluid analysis (using seminal fluid collecting device) - 2nd cycle s Medical Review - 3rd cycle s Ultrasound Evaluation s Ultrasound Follicle Tracking s Diagnostic Laparoscopy and Hysteroscopy - 6th cycle s 12 effective cycles of medical treatment

25. 24 45 MINUTES per CONSULTATION

26. 25 The Couple manage their own fertility under supervision by their “FertilityCare Physician” and Teacher-Practitioner

27. 26 Case Presentations 1. Case 1 2. Case 2 3. Case 3

28. 27 Case 1 s Married 8 years, Both Aged 35years. s 7 Pregnancy Losses 1993- 1999 u 10w, 18w, 31w, 26w, 26w, 17w, 17w u 2 miscarriages, 3 Stillbirths, 2 miscarriages. s Nurse s Attended 3 different Specialists, –Locally, Dublin, London

29. 28 Case 1 s Lupus Anticoagulant, s anticardiolipin Antibodies, s b2 glycoprotein 1, s Rheumatoid factor, s ANA, CRP, ALL NORMAL s Chromosomes, s TORCH s Hysteroscopy

30. 29 Case 1

31. 30 Case 1 s Low Progesterone s Low Oestradiol 17 Beta s Raised TSH 8.5

32. 31 Case 1 s Corrected Hormonal Deficiencies Preconception with –Clomid 50mg od x 3/7 –Eltroxin 50ug daily –HCG 2000, P+3,5,7,9.

33. 32 Case 1 s Conceived with optimum hormone levels s Took Prog 200mg x2 /w, HCG 5000 x2 /w Aspirin, Heparin. s Prog. Support for 30 weeks s Delivered Healthy Baby Girl, Eilís s Induced at 39 weeks, Nov ‘00. s NVD Weight 7lb 11oz.

34. 33 Case 1 s Conceived with same Rx 14 months later s Delivered live female in March ‘02 s Elective LSCS at 41 weeks, Weight 9 lbs. 1 oz

35. 34 Case 2 s Primary Dx Fibroids – Myomectomy 1996 s Female infant 1997 NVD s Unable to conceive since then

36. 35 Case 2 s Age 37 yrs. G1 P1 s Secondary Infertility 1999 u LAP – Adhesions secondary to myomectomy u Laparotomy repair s Rx Clomid x 3/12, FSH x 3/12 s IVF - Oct. 00, and again frozen transfer Feb. 01 ( 1 IVF 2 Embryo T/F) u ??Suitable for NaPro

37. 36 Case 2 s FertilityCare Chart – Normal in appearance

38. 37 Case 2 s Peak + 7 s Peak + 3,5,7,9,11

39. 38 Case 2

40. 39 Case 2 s Ultrasound Follicle Tracking

41. 40 Case 2 s Repeat Laparoscopy Apr 02 s Laparotomy and Microsurgery Dec 02 s Mucus enhancers s Stress management s FFI No Hormonal Treatment

42. 41 Case 2 s Conceived May 2003 s Excellent initial hormone levels s Dramatic drop at 6-7 weeks s Bleeding in pregnancy s Miscarried 8 weeks gestation s Probable Embryo factor

43. 42 Case 3 s Feb 99 s 37 yrs. Female, and Male s G 1 P 3 6 yr. Old Boy s SA 2 (12 and 13 weeks)

44. 43 Case 3

45. 44 Case 3 First Attempt s HCG 2000 P+3,5,7,9 s P+7 P = 66.6 nmol/l (20.7) E2 = 301 pmol/l (82.0) s ADD Clomid 100mg daily x 5 days

46. 45 Case 3 First Attempt s P+7 P = 89.8 nmol/l (28.2) E2 = 290 pmol/l (79.0) s P+17 P = 61.8 nmol/l (19.4)

47. 46 Case 3 Second Attempt s Clomid 150 mg daily x 5 days s HCG 2000 P+3,5,7,9 s Add prednisolone 5mg daily s P+7 P = Usually normal E2 = Usually low

48. 47 Case 3 Ultrasound series

49. 48 Case 3 Blood Test Results s E2 - Pre Peak - 544 pmol/L (148 pg/ml) –aim > 1,000 nmol/l ( 370 g/ml) s P+7 - Prog - 99.1 nmol/L (31.1 ng/dl) E2 - 341 pmol/L (92.9 pg/ml)

50. 49 Case 3 Outcome s Renal Agenesis s Baby Boy RIP – 26 weeks approx.

51. 50 Case 3 3rd Attempt s Puregon (FSH) 100 iu sc daily for 10 days, start day 3 of cycle s HCG 5,000 sc on day 12 s Cyclogest (Progesterone) PV 400mg for 10 nights s STRESS MANAGEMENT s 6th cycle ready to try

52. 51 Case 3 Blood Test Results s Ultrasound 2 follicles, one 22 x 20mm s E2 - Pre Peak - Not available s P+7 - Prog - 122.1 nmol/L (38.3 ng/dl) E2 - 899 pmol/L (245 ng/dl)

53. 52 NaProTechnology ® A Family Physician’s Protocol Dr. Phil Boyle MICGP MRCGP CNFPMC Toronto July ‘03

54. 53 The Irish NaPro Statistics s Approx. 1200 couples over 4 years s Average Female age - 36yrs. s Average time trying to conceive - 5yrs. s Approx. 25% - history of unsuccessful IVF

55. 54 Estimated Success s Approx. 340 successful Pregnancies s Approx. 25 - 30% success overall u Substantially higher with lifetable analysis, accounting for dropouts u still in preparation for publication

56. 55 Questions Dr. Phil Boyle MICGP MRCGP CFCMC Toronto July ‘03