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NaProTechnology Natural Procreative Technology
A multifactorial approach to the chronic problem of Infertility
Dr. Phil C. Boyle MICGP, MRCGP, CFCMC
Galway Clinic, Ireland
Prof. Joseph Stanford MD,
University of Utah, USA
03 Sept 2011
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Outline
Abstract Summary3 Case PresentationsDiscussion points
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Illness can be ……
Acute
Sudden onsetShorter durationMay resolve spontaneously Tend to have single or few causesMay be cured by single intervention or treatment
Chronic
Gradual onsetLonger durationRarely resolve spontaneously Usually have multiple causesOutcomes improved with multiple sustained interventions
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Health conditions
Acute
AppendicitisRespiratory viral infectionFractured bone
Chronic
AsthmaDiabetesDegenerative arthritis
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Infertility (subfertility) is a chronic health condition.
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Infertility
Gradual, unknown, or early onsetOngoing issuesPotential for recurrenceSyndrome, not diagnosisMany possible causesUsually, more than one cause or factor present
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Infertility
Rarely completely “cured” by single interventionCan be treated with multiple interventionsRarely resolves spontaneously
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Chronic vs Acute approach
NaProTechnologyInfertility indicates the presence of disease with the challenge to diagnose and treat for optimum health.
ARTInfertility presents a technical challenge to bypass the dysfunctional process.
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Chronic vs Acute approach
NaProTechnologySeeks to identify long-term health conditions and improve them over a reproductive lifetimeChronic perspective
ARTLong term health conditions are considered less important for short-term treatment.Acute perspective
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Description
Infertility is usually a consequence of multiple chronic conditions rather than a single acute condition. We propose that it is erroneous to apply acute medical interventions to a condition that is chronic in nature.
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Infertility & Miscarriage
Infection
Low Endorphins
Diet &Nutrition
Surgical
Immunological
Male Factor
AdrenalFatigue
Low Hormones
OthersTo be discovered
Limited Mucus
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Possible Diagnoses from NaProTechnology Evaluation
Hormonal Ultrasound Surgical Other Low Progesterone Immature follicle Endometriosis Limited (hostile)
Mucus
Low Oestradiol Partial rupture Pelvic Adhesions Adrenal Fatigue Poor Follicular
FunctionLuteinised unruptured
follicleBlocked Fallopian
TubesChronic Endometritis
Corpus Luteum Insufficiency
Delayed Rupture Hydrosalpinx Endorphin Deficiency *Polycystic Ovaries Afollicularism Fibroid Food Intolerance
Reduced ovarian reserve
Absent Cumulus Oopherous
Polyp Nutritional Deficiency
Hypothyroidism Uterine Septum Immune dysfunction
Fig. 3
*Although these diagnoses are hormonally mediated, at least in part, the diagnosis and management is not based on direct hormonal testing at this time.
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Method
Retrospective analysis of 3 case studies which demonstrate the multifactorial and chronic nature of infertility that were previously managed unsuccessfully with acute intervention using IVF (in Vitro Fertilisation) or ART (Assisted Reproductive Technology).
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Results
Demonstration of the multifactorial approach and 3 successful singleton live births using NPT (Natural Procreative Technology or NaProTechnology).
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Conclusion
Infertility can be treated successfully with a multifactorial approach which takes into account the chronic nature of infertility and targets treatment to manage multiple factors responsible for the condition.
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Discussion
Infertility is not a diagnosis but is often the expression of several underlying ill health conditions which if diagnosed and treated correctly will result in restoration of normal reproductive function.
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Discussion - Continued
Physicians ought to consider broader diagnostic possibilities in their evaluation of infertile couples. A multifactorial treatment strategy for the chronic condition of infertility may be more effective than the widespread acute strategy employed by ART.
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Discussion - Continued
Future studies looking at NPT and ART outcomes Must be cohort studies andCompare populations with similar patient characteristics
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3 Case Presentations
1. Case A2. Case B3. Case C
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Case A
Gravida 0 Para 0, Female aged 41, Male aged 40, Trying to conceive for 2 years, Unexplained infertility, 3 failed IUI and 2 failed IVF.
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Case A
Presented for treatment – March 2009Unexplained Infertility
Lap and Dye – normal 2007Semen analysis – normal 2007
IUI x 3 – FSH/LH and HCG - June 2008IVF x 2
3 Embryos transferred – Aug 2008 & March 2009
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Case A – NPT Diagnoses
Chronic EndometritisProgesterone deficiency
poor follicular function & corpus luteum insufficiency
Hostile Cervical MucusClinical endorphin deficiencyMild food intolerance
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Case A – NPT Treatments
Clinical endorphin deficiencyNaltrexone 2mg nocte
Mild food intolerance (IgG) Egg yolk and soya
www.camnutri.com
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Case A – NPT treatment
Progesterone deficiency poor follicular function & corpus luteum insufficiency
Letrozole 2.5mg 10 tabs on day 3HCG 10,000 iu mid cycle HCG 2,500 iu Peak +3,5,7
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Case A – NPT Treatments
Hostile Cervical MucusCabroceistine 375mg tid x 7 days, day 11Amoxycillin 500mg tid x 5 days, day 11PreSeed Vaginal Lubricant
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Case A – NPT Treatments
Chronic EndometritisMetronidazole 400mg BD x 3 weeksClarithromycin 500mg BD x 3 weeksPro biotic for 6 weeks
Start day 14 of cycle
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Positive Test!
Antibiotic treatment10 F
10 F
H H H H
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Case A
42 years old at conception. Hormone support with cyclogest 400mg pv. twice daily until 8 weeks Cyclogest 400mg pv nocte until 16 weeks gestation
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Case A
She delivered a healthy baby boy by Caesarean section in November 2010, weighing 3180g.
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Case A
CrMS Chart was critically important to the process
Timing of blood testsTiming of HCG injectionsIdentify hostile mucusIdentify Brown Bleed – Chronic Endometritis
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Case A
IVF which attempted to solve the symptom of infertility through bypassing the natural process of conception was inappropriate and ineffective as she had several chronic conditions that needed to be treated in a targeted fashion to restore normal reproductive function
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Case B
Gravida 1 Para 0 Female aged 37 Male aged 39 7 years trying to conceive Mildly polycystic ovaries and recurrent implantation failure3 failed IVF cycles, 3 fresh & 1 frozen transfer.
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Case B
Presented on April 2009Trying to conceive since Jan 2002Cycle 32 to 25 daysUnplanned miscarriage at 11 weeks – 1999Diagnosis – Mild PCOD by ultrasound
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Case B – Normal investigations
Laparoscopy ’01 &’08, Hysteroscopy ‘09Semen analysis several tests – ’01- ’08Day 3 bloodsThrombophillia ScreenImmunological testing “Chicago Bloods”
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Case B – Treatments
Clomiphene 50mg daily for 5 days, from day 3 of cycle x 4100mg daily for 5 days, from day 3 of cycle x 4150mg daily for 5 days, from day 3 of cycle x 4
12 cycles in total previously
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Case B – Treatments
IVF x 3 stimulated cycles Feb 2006 – March 2009Embryo transfer – 3 fresh and 1 frozen
2 – 3 embryos each timeAdditional Aspirin, Enoxaparin, Prednisolone 25mg with last IVF cycle despite normal testing
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Case B – NPT Diagnoses
Progesterone deficiency – with corpus luteum insufficiency - Dramatic chart!Polycystic Ovaries – with poor follicular functionClinical endorphin deficiencyClinical Adrenal fatigue
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6 7
9
6
10F H HHHH 12
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Case B – NPT Treatments
Progesterone deficiency – with corpus luteum insufficiency - Dramatic chart!Polycystic Ovaries – with poor follicular function
HCG 2,500iu P+3,5,7,9Letrozole 2.5mg – 16 tabs – day 3HCG 10,000 iu mid cycle
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H H
H HHH
H
HH
H HH10F
10F
10F
17
14
12
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Case B – NPT Treatments
Clinical endorphin deficiencyNaltrexone 3mg nocte
Clinical Adrenal fatigueHydrocortisone 5mg – 7am & 12 noon
SupplementsVitamin D3 – 2,400iu dailyOmega 3 2000mg daily plus Folic acid
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Case B – NPT Outcome
With treatment we achieved a normal appearing CrMS chart, with proven follicle rupture by ultrasound, and a healthy happy patient. She conceived on her 5th cycle of treatment (second effective cycle) in April 2010
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16F H HHH
Positive Test!
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Case B – NPT Pregnancy treatment
Cyclogest 400mg pv twice daily until 36 weeks gestation
Aspirin 75mg daily until 30 weeks Prednisolone 25mg daily until 12 weeks
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Case B – NPT Pregnancy Outcome
She had a normal vaginal delivery of a healthy baby boy, 3.130 Kg in January 2011
Mother was 38 years old at delivery
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16F H HHH
Positive Test!
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Case B – Comments
Immediately identified Corpus luteum insufficiency & confirmed restoration of normal function with treatment.Patient’s well being improved with naltrexone and cortisol treatment. When this happens, we often find our treatment is more successful.
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Case B – Comments
Although we did not feel aspirin or prednisolone were necessary we conceded to the patients request to give these medications as recommended by her previous doctor
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Case C
Gravida 1 (with IVF), Para 0Female age 38, Male age 38Oligoasthenozoospermia, progesterone deficiency and endometriosis. 12 cycles of clomiphene3 IUI 3 IVF cycles
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Case C
Presented in January 2008, female aged 38Never conceived naturally since trying in February 2003.28 to 32 day cycleLaparoscopy 2003 – Mild Endometriosis
Unclear if this was treated
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Case C – Semen Analysis
Oligoasthenozoospermia
Count 6 to 17 million per ml Motility 25 – 37%.
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Case C – Previous Treatments
12 cycles of ovulation induction with clomiphene, 3 attempts at IUI 3 failed IVF attempts between Dec 2005 and April 2007
2 embryos replaced x 3 IVF cyclesMiscarriage at 9 weeks after first attempt
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Case C – NPT Diagnoses
EndometriosisOligoasthenozoospermiaClinical endorphin deficiencyLow progesterone and oestradiol –combined poor follicle function and corpus luteum insufficiency Obvious from ChartFood Intolerance to eggs
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Pre-menstrual Spotting with low progesterone levels
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Case C – NPT Treatments
Clinical endorphin deficiencyNaltrexone 4.5mg nightly
Food Intolerance to eggsChange in diet
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Case C – NPT Treatments
EndometriosisLaparoscopy and diathermy June 2008
OligoasthenozoospermiaCoEnzyme Q10 200mg dailyTamoxifen 20mg dailyFertilityPlus for menLifestyle – (cigarettes, alcohol, caffeine, stress)
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Case C – NPT Treatments
Low progesterone and oestradiol –combined poor follicle function and corpus luteum insufficiency
Clomiphene 150mg daily x 3 days, starting on day 3 of the cycle with HCG 5000 iu mid cycle to facilitate follicle rupture and HCG 2,500 iu on days 3, 5 and 7 after ovulation
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Laparoscopy
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Positive Test!
Laparoscopy
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Case C – NPT Pregnancy Treatments
Positive pregnancy test in September 2008 Cyclogest 400mg pv nocte until 14 weeks Naltrexone 4.5mg nocte until 38 weeks
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Case C – NPT Pregnancy outcome
They had a healthy baby boy by normal vaginal delivery weighing 3.400kg in June 2009, when mum was 40 years old.
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Case C – repeat attempt
Second attempt in February 2010 Same treatment approach successfully conceived by September 2010.
Healthy baby boy delivered 19th May 2011 when mum was 42 years old.
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Case C – Comments
CrMS chart demonstrated premenstrual spotting indicating a problem with endometrial integrity in the luteal phase of the cycleIt is important to adequately treat mild endometriosis as this has been shown to improve pregnancy and live birth rates
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Case C – Comments
We continued Naltrexone throughout pregnancy in this case because the patient felt dramatically better preconception with treatment. It appears she had significant endorphin deficiency which needed ongoing treatmentOver 100 pregnancies with naltrexone
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Appropriate Diagnosis
NaProTechnology
Seeks to diagnose all underlying causes.Seeks to identify all possible exacerbating and mitigating factors.
ARTLess concerned about diagnosis except for factors that may directly impact effectiveness of IVF treatment.
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Appropriate Treatment
NaProTechnology
Seeks to optimize health of baby, mother, father
ARTAcute approach- do something to get pregnant as quickly as possible, almost at any cost
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Impact on health of the baby
NaProTechnologyExpected lower miscarriage rates Low birth weight rates under 5%Expected lower rates of prematurity, perinatal mortality
ARTHigh miscarriage ratesLow birth weight rates 30%+Also higher rates of prematurity (2.0x), perinatal mortality (2.2x), and birth defects (2.0x)
J Amer Board Fam Med, 2008 Obstet Gynecol 2004 NEJM 2002
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Appropriate evidence
“Chronic” approach
Cumulative outcomes over timeCohort analysisFull picture
“Acute” approachShort-term outcomes onlyNo context for cumulative outcomes over timeMisleading
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Appropriate evidence
Case C - 3 failed IVF
Miscarriage at 9 weeksRecorded as “Success” with IVFClinical pregnancy following embryo transferA Cohort analysis would not do this
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National Registries for ART
USA- SART and CDCEurope- ESHREUK- HFEAAll have data in terms of treatment cycles
Unknown number of womenUnknown cycles per woman
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Cochrane evaluation of IVF
Outcomes should be reported as pregnancy rates per woman or couple, because repeat cycle data are not statistically independent and are less relevant to the patient.
Pandian et al. Cochrane Database Sys Rev 2005
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Cochrane evaluation 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 et al. Cochrane Database Sys Rev 2005
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Cumulative pregnancy rates
Stanford JB, et al. Fertil Steril 2010
In couples without clear indications for IVF, the main benefit of early IVF may be to shorten time to pregnancy, a benefit that must be weighed against costs and potential adverse outcomes.
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Cumulative live birth rates
Per couple, not per cycleAdjusted live birth rates
Couples who drop-out of treatment are no longer counted after they drop out
Crude live birth ratesInclude all couples who start treatment, whether or not they continue (intention to treat)
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Cumulative live birth rates-example
100 couples50 drop out after 3 months50 get pregnant after 9 monthsCrude live birth rate: 50%Adjusted live birth rate: 100%“True” value somewhere in between
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Appropriate evidence
Accounts for population characteristics that impact the prognosis
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Comparing cohorts- NPT and ART Ireland NPT Netherlands ART
Hum Reprod 2007JABFM 2008
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Comparing cohorts- NPT and ARTNetherlands ARTN=1351Mean female age=32.8Duration infertility=3.6 yrsPrior ART=0%Prior pregnancy=47%1 year
Adjusted=64.7% pregnancyCrude=42.4 pregnancy
Ireland NPTN=1072Mean female age=35.8Duration infertility=5.6 yrsPrior ART=33%Prior pregnancy=47%2 years
Adjusted=52.8% BIRTHCrude=25.5% BIRTH
Hum Reprod 2007JABFM 2008
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Comparing cohorts- NPT and ARTNetherlands ARTN=1351Mean female age=32.8Duration infertility=3.6 yrsPrior ART=0%Prior pregnancy=47%1 year
Adjusted=64.7% pregnancyCrude=42.4 pregnancy
Ireland NPTN=1072Mean female age=35.8Duration infertility=5.6 yrsPrior ART=33%Prior pregnancy=47%2 years
Adjusted=52.8% BIRTHCrude=25.5% BIRTH
Hum Reprod 2007JABFM 2008
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Comparing cohorts- NPT and ARTNetherlands ART
Twins 22%Birth < 2500 grams
Not reported
Ireland NPT
Twins 4.5%Birth < 2500 grams
4.5%
Hum Reprod 2007JABFM 2008
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Spiritual dimensions
NaProTechnology
Partnership between CFCP, CFCMC, coupleAcknowledges God inherentlyGoal is healthy baby, mother, father
ARTTechnological accomplishment of the physicianPromotes mastery of manGoal is a baby, quickly, at almost any cost
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Spiritual dimensions
NaProTechnology
Profound respect for human life from its earliest stages of development
ARTEmbryonic stages of life are treated instrumentally as a means to an end
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Summary
Infertility is a chronic health condition, and should be diagnosed and treated accordingly.
The diagnostic evaluation should search for all underlying causes and contributing factors.
Treatment should address all known causes and contributing factors, in order to maximize health of the baby, mother, and father.
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Summary
Evaluation of infertility treatment outcomes should be done on a cohort basis, over time.
Comparisons between studies need to account for differences in study populations.
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Summary
NaProTechnology has comparable live birth rates to ART, with healthier babies.
NaProTechnology seeks to maximize the long-term health outcomes for baby, mother, and father.
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NaProTECHNOLOGYAny Questions?
Dr. Phil Boyle