NaProTechnologyAn Integrated Approach to Infertility

Joseph B. Stanford, MD, MSPH

Health Research Center

University of Utah Hospital and Medical School

USA

13 December 2004

Dr. Phil C. Boyle, IrelandDr. Tracey Parnell, CanadaDr. Kevin McCarthy, UK

Dr. Amanda Lamont, AustraliaDr. Thomas W. Hilgers, USA

Background: Infertility The NaProTechnology approach

– Creighton NaPro Tracking– NPT Evaluation– NPT Intervention

NPT Diagnoses– Patients who failed IVF, conceived with NPT

Success rates– Per cycle versus cohort – Live Births– Multiple Gestation

Illustrative case study Comments

Infertility is a common problem

10-15% of couples Couples problem- both woman and man Need for an integrated primary

approach

NaProTechnology (NPT) Natural Procreative Technology A systematic approach to normalize and

optimize reproductive function in women and men. – Conception occurs naturally, in vivo.

Components– Health education: Creighton NaPro Tracking– Medical evaluation and management– Surgical treatment, as indicated

NPT Development Developed in USA (centered at

Creighton University) 1980 Creighton NaPro Tracking 1991 first monograph on systematic

medical approach 2004 textbook published on medical and

surgical aspects– 1244 page, 90 chapters, over 2000

references

www.naprotechnology.com

Most of the medical and surgical techniques have been used

previously, but NPT integrates these in a fertility charting system

(Creighton Model NaPro Tracking) that empowers the patient and

provides key information to guide investigation and treatment.

Creighton Model NaPro Tracking is the cornerstone, foundation, and unifying framework for NPT.

A Standardised Modification of the

Billings Ovulation Method

Taught by trained health educators (FertilityCare Teachers)

Creighton Model NaPro Tracking:Vaginal discharge biomarkers

Creighton Model NaPro Tracking:Vaginal discharge biomarkers

Highly correlated with ovulation Changes precede ovulation Maximizes time available for intercourse

to try to conceive Gives information about sperm survival Easily observed by women

Estrogen/Progesterone curves

Type E and G mucus at cervix

Coronal section of cervix: the biological valve

Estrogenic and progestogenic mucus- light microscopy

Type E mucus and sperm transport

Probability of Clinical Pregnancy

Creighton Model NaPro Tracking is optimal for timing

intercourse to achieve pregnancy.

Better than BBT, urine LH, calendar calculations

Creighton Model NaPro Tracking is optimal for timing

intercourse to achieve pregnancy.

AND it provides key information to guide

diagnostics and adjust therapy.

NPT DiagnosisFUNCTIONALFUNCTIONAL Hormone deficiency - Follicular or Luteal? Ovulatory defect - Anovulation, Luteinised

Unruptured Follicle Syndrome, Partial follicular rupture.

Limited Cervical Mucus Flow Male Factor

STRUCTURALSTRUCTURAL Surgical - Endometriosis, PCOD, Fibroids,

Polyp, Uterine Septum, PID.

NPT TreatmentFUNCTIONALFUNCTIONAL Luteal Phase Support - HCG, Progesterone Mucus Enhancers - Vitamin B6, Mucolytics,

Antibiotics Stress Management Male Treatment Ovulation Induction - Clomiphene, HCG, FSH

STRUCTURALSTRUCTURAL Surgical - Endometriosis, Ovarian Diathermy,

Fibroids, Polyp, Uterine Septum, PID.

Twelve effective cycles Adequate mucus flow (CrM chart) Repeated intercourse during days with

mucus flow (fertile days) (CrM chart) Optimal progesterone and oestradiol

levels on 7th day after peak (CrM chart) Attention to manage stress

appropriately Other medical/surgical issues identified

and addressed (CrM chart)

NPT Infertility Protocol

Initial Medical Consultation NaProTracking for 2 cycles Blood Tests & Seminal fluid analysis Medical Review - 3rd or 4th cycle Ultrasound Evaluation Ultrasound Follicle Tracking Consider Diagnostic Laparoscopy and

Hysteroscopy - 6th cycle 12 effective cycles of medical treatment

45 MINUTES per

CONSULTATION

Review of CrM chart, labs, andadjustment of medical treatment.Attention to psychosocial issues with appropriate referral

Diagnostic categories

NPT diagnostic categories95 couples, failed IVF, conceived

with NPT

Data from practice of

Dr. Phil C. Boyle, Galway, Ireland

Prior diagnostic categories

95 Couples ART Diagnosis

0

55

22

101

102

117 8

13

010

2030

4050

60

Conceived pre IX

unexplained endometriosis

low progesterone

low estrogen not ovulating

hostile/limited mucuspoor semen analysis

blocked tubespelvic adhesions

Other

NPT diagnostic categories

95 Couples NPT Diagnosis

150

22

7361

4

43

11 7 823

01020304050607080

Conceived pre IXour unexplainedour endometriosis

our low progesteroneour low estrogenour not ovulating

our hostile/limited mucusour poor semen analysis

our blocked tubesour pelvic adhesions

Other

95 Couples Medical / Surgical Rx

23

49 48

14

51

7 1015

84

17

0102030405060708090

FFI

Mucus enhancers

HCG

CyclogestClomid

Male treatment

OtherSurgeryGestone

HCG in pregnancy

NPT treatments

Months of treatment to first conception95 Couples previous failed ART

2

7

10 10

7 7

4

2

6

8

4 4 43 3

4

10

0

2

4

6

8

10

12

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16-20

20+

Months

Number of couples

Time to pregnancy with NPT

Effectiveness in infertility

Per cycle success rates are not appropriate for NPT – Can be misleading for any infertility

treatment Cohort-based measures are

appropriate. Crude rates will underestimate

effectiveness. Traditional life tables will

overestimate effectiveness to an unknown extent.

National ART registries

All data in terms of treatment cycles– Unknown number of women, cycles per

woman, or centers per woman USA 2001

– 38% pregnancy per transfer– 25% live birth per cycle of treatment

Very few RCTs of IVF

“The effectiveness of IVF relative to other treatment options for unexplained infertility remains unproven. Adverse events and the costs associated with the interventions compared have not been adequately assessed. ”

Pandian Z, Bhattacharya S, Nikolaou D, Vale L, Templeton A.. In vitro fertilisation for unexplained subfertility (Cochrane Review). In: The Cochrane Library , Issue 4, 2003.

Chichester, UK: John Wiley & Sons, Ltd.

Stolwijk et al 1996

IVF for up to 6 cycles. Estimated life table rates

– Crude rate 29.5– Traditional life table 56.0– Adjusted life table 34.4

Two other cohorts with similar results.

Irish NPT Study

Over 1239 couples – Entered treatment Feb. 1998 through Jan.

2002 Average Female age 36.1 yrs. Average time trying to conceive 5.2 yrs. 28.6% with history of unsuccessful IVF

Irish NPT Study

Crude live birth rate 25.5 Lifetable live birth rate 46.3

– Lifetable is at 24 months, which corresponds roughly to 12 effective cycles.

Irish NPT Study

No prior IVF crude LT– Age <= 37 yrs 32.0 53.6– Age >=38 yrs 20.3 43.8

Prior failed IVF– Age <= 37 yrs 21.6 38.8– Age >=38 yrs 15.1 25.3

NPT neonatal morbidity

Preterm birth rate <6% Low birth rate <8%

NPT Twins 4.1 %, compared with 28% IVF (HFEA) Less prematurity, low birth weight,

morbidity, mortality and cost