naprotechnology an integrated approach to infertility joseph b. stanford, md, msph health research...
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NaProTechnologyAn Integrated Approach to Infertility
Joseph B. Stanford, MD, MSPH
Health Research Center
University of Utah Hospital and Medical School
USA
13 December 2004
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Dr. Phil C. Boyle, IrelandDr. Tracey Parnell, CanadaDr. Kevin McCarthy, UK
Dr. Amanda Lamont, AustraliaDr. Thomas W. Hilgers, USA
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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
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Infertility is a common problem
10-15% of couples Couples problem- both woman and man Need for an integrated primary
approach
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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
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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
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www.naprotechnology.com
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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.
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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)
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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
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Estrogen/Progesterone curves
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Type E and G mucus at cervix
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Coronal section of cervix: the biological valve
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Estrogenic and progestogenic mucus- light microscopy
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Type E mucus and sperm transport
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Probability of Clinical Pregnancy
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Creighton Model NaPro Tracking is optimal for timing
intercourse to achieve pregnancy.
Better than BBT, urine LH, calendar calculations
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Creighton Model NaPro Tracking is optimal for timing
intercourse to achieve pregnancy.
AND it provides key information to guide
diagnostics and adjust therapy.
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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.
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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.
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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)
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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
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45 MINUTES per
CONSULTATION
Review of CrM chart, labs, andadjustment of medical treatment.Attention to psychosocial issues with appropriate referral
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Diagnostic categories
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NPT diagnostic categories95 couples, failed IVF, conceived
with NPT
Data from practice of
Dr. Phil C. Boyle, Galway, Ireland
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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
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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
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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
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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
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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.
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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
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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.
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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.
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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
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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.
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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
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NPT neonatal morbidity
Preterm birth rate <6% Low birth rate <8%
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NPT Twins 4.1 %, compared with 28% IVF (HFEA) Less prematurity, low birth weight,
morbidity, mortality and cost