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

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

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

4 IVF- Diagnosis before Treatment 42% Unexplained

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

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)

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

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

9 Targeted Hormone Evaluation Investigation Level 1.

10 Targeted Hormone Evaluation (Investigation Level 1.) s Peak Plus 7 Progesterone ( ng/dl) ( 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)

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

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

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

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

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.

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

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

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

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

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

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

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

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

24 45 MINUTES per CONSULTATION

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

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

27 Case 1 s Married 8 years, Both Aged 35years. s 7 Pregnancy Losses 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

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

29 Case 1

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

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.

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.

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

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

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

36 Case 2 s FertilityCare Chart – Normal in appearance

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

38 Case 2

39 Case 2 s Ultrasound Follicle Tracking

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

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

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)

43 Case 3

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

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)

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

47 Case 3 Ultrasound series

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

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

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

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

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

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

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

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