Na Pro Technology A Family Physicians Protocol Toronto

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

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

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

IVF- Diagnosis before Treatment 42% Unexplained 4

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

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

The Fertility. Care. 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 7

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

Targeted Hormone Evaluation Investigation Level 1. 9

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) 10

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

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

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 13

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

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

Treatment FUNCTIONAL s Luteal Phase Support - HCG, Progesterone s Mucus Enhancers - Vitamin B 6, Mucolytics, Antibiotics s Stress Management s Male Treatment s Ovulation Induction - Clomiphene, HCG, FSH, Gn. RH STRUCTURAL s Surgical - Endometriosis, Ovarian Diathermy, Fibroids, Polyp, Uterine Septum, PID. AIM is to restore normal Function over 12 effective cycles 16

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

The Creighton Model Fertility. Care. TM System s The Fertility. Care. TM system is the cornerstone to evaluation and treatment with Na. Pro. Technology® s Everything is built on or around the fertility chart 18

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

Charting abnormalities 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 20

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

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

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

45 MINUTES per CONSULTATION 24

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

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

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

Case 1 s s s s Lupus Anticoagulant, anticardiolipin Antibodies, b 2 glycoprotein 1, Rheumatoid factor, ANA, CRP, ALL NORMAL Chromosomes, TORCH Hysteroscopy 28

Case 1 29

Case 1 s s s Low Progesterone Low Oestradiol 17 Beta Raised TSH 8. 5 30

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

Case 1 s s s Conceived with optimum hormone levels Took Prog 200 mg x 2 /w, HCG 5000 x 2 /w Aspirin, Heparin. Prog. Support for 30 weeks Delivered Healthy Baby Girl, Eilís Induced at 39 weeks, Nov ‘ 00. NVD Weight 7 lb 11 oz. 32

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 33

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

Case 2 s s Age 37 yrs. G 1 P 1 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 Na. Pro 35

Case 2 s Fertility. Care Chart – Normal in appearance 36

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

Case 2 38

Case 2 s Ultrasound Follicle Tracking 39

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

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

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

Case 3 43

Case 3 First Attempt s HCG 2000 P+3, 5, 7, 9 s P+7 P = 66. 6 nmol/l (20. 7) E 2 = 301 pmol/l (82. 0) ADD Clomid 100 mg daily x 5 days s 44

Case 3 First Attempt s P+7 P = 89. 8 nmol/l (28. 2) E 2 = 290 pmol/l (79. 0) s P+17 P = 61. 8 nmol/l (19. 4) 45

Case 3 Second Attempt s s Clomid 150 mg daily x 5 days HCG 2000 P+3, 5, 7, 9 Add prednisolone 5 mg daily P+7 P = Usually normal E 2 = Usually low 46

Case 3 Ultrasound series 47

Case 3 Blood Test Results s E 2 - 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) E 2 - 341 pmol/L (92. 9 pg/ml) 48

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

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

Case 3 Blood Test Results s Ultrasound 2 follicles, one 22 x 20 mm s E 2 - Pre Peak - Not available s P+7 - Prog - 122. 1 nmol/L (38. 3 ng/dl) E 2 - 899 pmol/L (245 ng/dl) 51

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

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

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 54

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