NaProTechnology after previous IVF Galway, Ireland

Transcription

1 NaProTechnology after previous IVF Galway, Ireland Salt Lake City, July 2012 Dr. Phil Boyle MICGP, MRCGP, CFCP

2 IVF Report.. Sunday Times in 6 couples - Infertility 1.25% (1 in 80) have IVF Birth 50% of women who try IVF do not need it! They could conceive naturally! Dr. Sami David New York s first IVF baby

3 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan new couples attempted NaProTechnology with a history of previous IVF (Jan ) 6 years, all treatment concluded by Jan Total of 839 previous IVF attempts Average of 2.1 IVF attempts per couple

4 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Couples Previous IVF 4% 21% 17% 58% Never conceived Live birth natural Live birth IVF Miscarriage 79% No previous Live Birth

5 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Couples Previous IVF - Female Age < Years old Average Female Age 37.1 years

6 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan 2012 Years trying to conceive <2yrs 3-4yrs 5-6yrs 7-9yrs >10yrs 5.8 years Trying to conceive

7 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan 2012 Exclusion Criteria (112 couples) Those who attended for only 1 medical consultation = 104 couples Irreversible Severe Male factor 8 couples

8 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan 2012 ESHRE European Society for Human Reproduction and Embryology Average success rates for all of Europe Ireland 21% Live Birth rate

9 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan 2012 ESHRE European Society for Human Reproduction and Embryology Average success rates for all of Europe Ireland 21% Live Birth rate BUT!...We are looking at the unsuccessful 79% of couples with an average of 2 previous IVF

10 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan 2012 In addition.. Consider how many people with a Respiratory Tract Infection respond favorably to antibiotic treatment 2 days of treatment 3 days 4 days 5 days. Highest success

11 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan couples attempted NaProTechnology with previous IVF 130 Conceptions (from 106 couples) 299 Did not conceive 106 / 405 = 26.2% crude conception rate 77/ 405 = 19.0% crude live birth rate

12 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan % crude conception rate 19% crude live birth rate Includes all couples of all ages who had 2 or more medical consultations Not a fair reflection on true success rate for couples who use NaProTechnology to its full potential

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14 299 couples Discontinued Group Jan Jan 2012 # Consults Quit Early NPT failed Total 2 63 (83%) 13 (17%) (70%) 23 (30%) (51%) 37 (49%) (23.5%) 26 (76.5%) (100%) (100%)

15 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Conceptions (from 106 couples) 299 Did not conceive 164 Quit treatment too Early (55%) 135 NaPro Treatment Ineffective

16 Reasons for Ineffective NaPro Treatment Severe non responsive male factor Unresponsive Anovulation Ovarian Failure Persistent LUF Non Reparable Blocked Tubes Completely Dry Cycle

17 299 couples Discontinued Group Jan Jan 2010 # Consults Quit Early NPT failed Total 2 63 (83%) 13 (17%) (70%) 23 (30%) (51%) 37 (49%) (23.5%) 26 (76.5%) (100%) (100%)

18 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Conceptions from 405 couples 299 Did not conceive - 2 or more consults 106/405 = 26.2% per couple conception rate

19 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Conceptions from 405 couples 299 Did not conceive - 2 or more consults 106/405 = 26.2% per couple conception rate 236 couples (299 63) 3 or more consults 106 / (342) = 30.9% per couple conception rate

20 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Conceptions from 405 couples 299 Did not conceive - 2 or more consults 106/405 = 26.2% per couple conception rate 236 couples (299 63) 3 or more consults 106 / (342) = 30.9% per couple conception rate 182 couples (236 54) 4 or more consults 106 / (288) = 36.8% per couple conception rate

21 Analysis of all couples Previous IVF attending the Galway Clinic Jan Jan Conceptions from 405 couples 299 Did not conceive - 2 or more consults 106/405 = 26.2% per couple conception rate 236 couples (299 63) 3 or more consults 106 / (342) = 30.9% per couple conception rate 182 couples (236 54) 4 or more consults 106 / (288) = 36.8% per couple conception rate 143 couples (182 39) 5 or more consults 106 / (249) = 42.6% per couple conception rate

22 405 Couples Previous IVF NaPro Conception and Live Birth Rates all ages Jan Jan 2010 # Consults Conception Rate Live Birth Rate 2 (299) 3 (236) 4 (182) 5 (143) 106/ % 106/ % 106/ % 106/ % 77/ % 77/ % 77/ % 77/ % Conception rate - based on 106 conceptions Live Birth rate - based on 77 Live Births

23 405 Couples Previous IVF NaPro Conception Rates Female age Jan Jan 2010 # consults < (299) 25/64 = % 39/88 = % 24/84 = % 13/39 = % 5/24= % Conception rate - based on 106 conceptions

24 405 Couples Previous IVF NaPro Conception Rates Female age Jan Jan 2010 # consults < (299) 25/64 = % 39/88 = % 24/84 = % 13/39 = % 5/24= % 3 (236) 25/55 = % 39/68 = % 24/62 = % 13/33 = % 5/18= % Conception rate - based on 106 conceptions

25 405 Couples Previous IVF NaPro Conception Rates Female age Jan Jan 2010 # consults < (299) 25/64 = % 39/88 = % 24/84 = % 13/39 = % 5/24= % 3 (236) 25/55 = % 39/68 = % 24/62 = % 13/33 = % 5/18= % 4 (182) 25/43 = % 39/48= % 24/48 = % 13/28 = % 5/15= % Conception rate - based on 106 conceptions

26 405 Couples Previous IVF NaPro Conception Rates Female age Jan Jan 2010 # consults < (299) 25/64 = % 39/88 = % 24/84 = % 13/39 = % 5/24= % 3 (236) 25/55 = % 39/68 = % 24/62 = % 13/33 = % 5/18= % 4 (182) 25/43 = % 39/48= % 24/48 = % 13/28 = % 5/15= % 5 (143) 25/36 = % 39/36= % 24/35 = % 13/22 = % 5/14= % Conception rate - based on 106 conceptions

27 405 Couples Previous IVF NaPro Live Birth Rates Female Age Jan Jan 2010 # consults < (299) 18/64 = % 30/88 = % 16/84 = % 10/39 = % 3/24= % 3 (236) 18/55 = % 30/68 = % 16/62 = % 10/33 = % 3/18= % 4 (182) 18/43 = % 30/48= % 16/48 = % 10/28 = % 3/15= % 5 (143) 18/36 = % 30/36= % 16/35 = % 10/22 = % 3/14= %

28 405 Couples Previous IVF NaPro Miscarriage Rates Per couple Jan Jan 2010 < Total 7/18 = % 9/30 = % 8/16 = % 3/10 = % 2/3=5 40.0% 29/77= % Including 2 Ectopic 2/106 = 1.8% 106 couples conceived 77 achieved 1 successful pregnancy 13 achieved 2 successful pregnancies 1 achieved 3 successful pregnancy 29 couples end result was miscarriage

29 So how do we Compare with IVF data?

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32 DIAGNOSTIC CHALLENGE Total 100%

33 DIAGNOSTIC CHALLENGE Total 100%

34 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 Function Corpus Luteum Insufficiency Luteinised unruptured follicle Delayed Rupture Blocked Fallopian Tubes Hydrosalpinx Chronic Endometritis Endorphin Deficiency * Polycystic Ovaries Afollicularism Fibroid Food Intolerance Reduced ovarian reserve Absent Cumulus Oopherous Polyp Nutritional Deficiency Hypothyroidism Male Factor Uterine Septum Immune dysfunction *Although this diagnosis is hormonally mediated, at least in part, the diagnosis and management is not based on direct hormonal testing at this time. Fig. 3

35 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 Function Corpus Luteum Insufficiency Luteinised unruptured follicle Delayed Rupture Blocked Fallopian Tubes Hydrosalpinx Chronic Endometritis Endorphin Deficiency * Polycystic Ovaries Afollicularism Fibroid Food Intolerance Reduced ovarian reserve Absent Cumulus Oopherous Polyp Nutritional Deficiency Hypothyroidism Male Factor Uterine Septum Immune dysfunction Fig. 3

36 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 Function Corpus Luteum Insufficiency Luteinised unruptured follicle Delayed Rupture Blocked Fallopian Tubes Hydrosalpinx Chronic Endometritis Endorphin Deficiency * Polycystic Ovaries Afollicularism Fibroid Food Intolerance Reduced ovarian reserve Absent Cumulus Oopherous Polyp Nutritional Deficiency Hypothyroidism Male Factor Uterine Septum Immune dysfunction Fig. 3

37 Infertility Diagnoses IVF Dx NaPro Unexpl. Inf Unexpl Misc Endometriosis low Prog low oestrogen anovulation hostile mucus male PCOS Fibroids PID tubal low ov. Res

38 Infertility Diagnoses IVF Dx NaPro Unexpl. Inf Unexpl Misc Endometriosis low Prog low oestrogen anovulation hostile mucus male PCOS Fibroids PID tubal low ov. Res Low Endorphins, Chronic Endometritis, Adrenal Fatigue, Immune Factor

39 DIAGNOSTIC CHALLENGE Total 100% NaPro 5% 85% 15% 70% 5% 30% 50% 1% 90% 95% NTP is a multifactorial approach of male and female factors and our totals exceed 100%

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41 Live Birth Rate 57.7% 38.2% 43.8% 13.3%

42 Live Birth Rate 57.7% 38.2% 43.8% 13.3% 41% Multiple pregnancy rate

43 13.3% # consults < (143) 18/ % 30/ % 16/ % 10/ % 3/ %

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47 Total IVF cycles = 99,467 Multiple pregnancies 27, % overall 14,191 6,132 5,065 1,821 Twins 24, % Triplets 2, % 1,

48 Multiple Pregnancy Rate 2 out of 77 Live Births = 2.6% 2 out of 106 conceptions = 1.9% No Triplet pregnancy

49 Prematurity Rate <35 weeks 35weeks 36weeks 37+weeks 1 (1.3%) 1 (1.3%) 6 (8.1%) 66 (89.2%) 2.6% of Babies born prior to 36 weeks Almost 90% of babies were born at 37 weeks or later

50 Birth Weights <1500g g >2500g Nil 6 70 Average Birth weight = 3,400g (7lbs 8 oz ) 92% of babies were over 2500g (5lb 8 oz)

51 Birth Defects None were reported

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58 ESHRE, Istanbul, July ,737 Danish women with infertility between 1973 and Women with Failed fertility treatment alcohol and substance increased by 103% schizophrenia increased by 47% Dr. Baldur-Felskov

59 ESHRE, Istanbul, July 2012 FET is more successful by 30% Pregnancy rate 38% in fresh transfer cycles, 50% in the FET cycles. Endometrial receptivity is better in un-stimulated cycles Prof. Checa, Barcelona

60 Simple cost analysis NPT approach $1,500 IVF approach $10, fold difference Difference in cost is almost 7 times higher for IVF babies in the general population..but in this study

61 Simple cost analysis NPT approach 405 x $1,500 = $607,500 resulting in 91 live births Cost per baby =$6,676 IVF approach 839 cycles x $10,000 = $8,390,000 resulting in 17 live births. Cost per baby = $493,529

62 Simple cost analysis NPT approach 405 x $1,500 = $607,500 resulting in 91 live births Cost per baby =$6,676 IVF approach 839 cycles x $10,000 = $8,390,000 resulting in 17 live births. Cost per baby = $493,529 Difference in cost is 74 times higher for IVF babies in this study This is without taking into account the 10 fold higher incidence of multiple pregnancies and the costs associated with premature births

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65 3 Case Presentations 1. Case A 2. Case B 3. Case C

66 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.

67 Case A Presented for treatment March 2009 Unexplained Infertility Lap and Dye normal 2007 Semen analysis normal 2007 IUI x 3 FSH/LH and HCG - June 2008 IVF x 2 3 Embryos transferred Aug 2008 & March 2009

68 Case A NPT Diagnoses Chronic Endometritis Progesterone deficiency poor follicular function & corpus luteum insufficiency Hostile Cervical Mucus Clinical endorphin deficiency Mild food intolerance

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70 Case A NPT Treatments Clinical endorphin deficiency Naltrexone 2mg nocte Mild food intolerance (IgG) Egg yolk and soya

71 Case A NPT treatment Progesterone deficiency poor follicular function & corpus luteum insufficiency Letrozole 2.5mg 10 tabs on day 3 HCG 10,000 iu mid cycle HCG 2,500 iu Peak +3,5,7

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73 Case A NPT Treatments Hostile Cervical Mucus Cabroceistine 375mg tid x 7 days, day 11 Amoxycillin 500mg tid x 5 days, day 11 PreSeed Vaginal Lubricant

74 Case A NPT Treatments Chronic Endometritis Metronidazole 400mg BD x 3 weeks Clarithromycin 500mg BD x 3 weeks Pro biotic for 6 weeks Start day 14 of cycle

75 10 F 10 F H H H H Antibiotic treatment Positive Test!

76 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

77 Case A She delivered a healthy baby boy by Caesarean section in November 2010, weighing 3180g.

78 Case A CrMS Chart was critically important to the process Timing of blood tests Timing of HCG injections Identify hostile mucus Identify Brown Bleed Chronic Endometritis

79 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

80 Case B Gravida 1 Para 0 Female aged 37 Male aged 39 7 years trying to conceive Mildly polycystic ovaries and recurrent implantation failure 3 failed IVF cycles, 3 fresh & 1 frozen transfer.

81 Case B Presented on April 2009 Trying to conceive since Jan 2002 Cycle 32 to 25 days Unplanned miscarriage at 11 weeks 1999 Diagnosis Mild PCOD by ultrasound

82 Case B Normal investigations Laparoscopy 01 & 08, Hysteroscopy 09 Semen analysis several tests Day 3 bloods Thrombophillia Screen Immunological testing Chicago Bloods

83 Case B Treatments Clomiphene 50mg daily for 5 days, from day 3 of cycle x 4 100mg daily for 5 days, from day 3 of cycle x 4 150mg daily for 5 days, from day 3 of cycle x 4 12 cycles in total previously

84 Case B Treatments IVF x 3 stimulated cycles Feb 2006 March 2009 Embryo transfer 3 fresh and 1 frozen 2 3 embryos each time Additional Aspirin, Enoxaparin, Prednisolone 25mg with last IVF cycle despite normal testing

85 Case B NPT Diagnoses Progesterone deficiency with corpus luteum insufficiency - Dramatic chart! Polycystic Ovaries with poor follicular function Clinical endorphin deficiency Clinical Adrenal fatigue

86 F H H H H H 12

87 Case B NPT Treatments Progesterone deficiency with corpus luteum insufficiency - Dramatic chart! Polycystic Ovaries with poor follicular function HCG 2,500iu P+3,5,7,9 Letrozole 2.5mg 16 tabs day 3 HCG 10,000 iu mid cycle

88 10F H H H H 12 10F H H H H 14 10F H H H H 17

89 Case B NPT Treatments Clinical endorphin deficiency Naltrexone 3mg nocte Clinical Adrenal fatigue Hydrocortisone 5mg 7am & 12 noon Supplements Vitamin D3 2,400iu daily Omega mg daily plus Folic acid

90 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

91 16F H H H H Positive Test!

92 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

93 Case B NPT Pregnancy Outcome She had a normal vaginal delivery of a healthy baby boy, Kg in January 2011 Mother was 38 years old at delivery

94 16F H H H H Positive Test!

95 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.

96 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

97 3 Case Presentations 1. Case A 2. Case B 3. Case C

98 Case C Gravida 1 (with IVF), Para 0 Female age 38, Male age 38 Oligoasthenozoospermia, progesterone deficiency and endometriosis. 12 cycles of clomiphene 3 IUI 3 IVF cycles

99 Case C Presented in January 2008, female aged 38 Never conceived naturally since trying in February to 32 day cycle Laparoscopy 2003 Mild Endometriosis Unclear if this was treated

100 Case C Semen Analysis Oligoasthenozoospermia Count 6 to 17 million per ml Motility 25 37%.

101 Case C Previous Treatments 12 cycles of ovulation induction with clomiphene, 3 attempts at IUI 3 failed IVF attempts between Dec 2005 and April embryos replaced x 3 IVF cycles Miscarriage at 9 weeks after first attempt

102 Case C NPT Diagnoses Endometriosis Oligoasthenozoospermia Clinical endorphin deficiency Low progesterone and oestradiol combined poor follicle function and corpus luteum insufficiency Obvious from Chart Food Intolerance to eggs

103 Pre-menstrual Spotting with low progesterone levels

104 Case C NPT Treatments Clinical endorphin deficiency Naltrexone 4.5mg nightly Food Intolerance to eggs Change in diet

105 Case C NPT Treatments Endometriosis Laparoscopy and diathermy June 2008 Oligoasthenozoospermia CoEnzyme Q10 200mg daily Tamoxifen 20mg daily FertilityPlus for men Lifestyle (cigarettes, alcohol, caffeine, stress)

106 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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108 Laparoscopy

109 Laparoscopy Positive Test!

110 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

111 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.

112 Case C repeat attempt Second attempt in February 2010 Same treatment approach successfully conceived by September The estimated date of delivery is 19th May 2011 when mum will be 42 years old.

113 Case C Comments CrMS chart demonstrated premenstrual spotting indicating a problem with endometrial integrity in the luteal phase of the cycle It is important to adequately treat mild endometriosis as this has been shown to improve pregnancy and live birth rates

114 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 treatment Over 100 pregnancies with naltrexone

115 Appropriate Diagnosis NaProTechnology Seeks to diagnose all underlying causes. Seeks to identify all possible exacerbating and mitigating factors. ART Less concerned about diagnosis except for factors that may directly impact effectiveness of IVF treatment.

116 Appropriate Treatment NaProTechnology Seeks to optimize health of baby, mother, father ART Acute approach- do something to get pregnant as quickly as possible, almost at any cost

117 Impact on health of the baby NaProTechnology Expected lower miscarriage rates Low birth weight rates under 5% Expected lower rates of prematurity, perinatal mortality ART High miscarriage rates Low 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

118 Appropriate evidence Chronic approach Cumulative outcomes over time Cohort analysis Full picture Acute approach Short-term outcomes only No context for cumulative outcomes over time Misleading

119 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.

120 Summary NaProTechnology has comparable live birth rates to ART, with healthier babies. NaProTechnology seeks to maximize the longterm health outcomes for baby, mother, and father.

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122 (IIRRM) International Institute for Restorative Reproductive Medicine Dr. Joe Stanford Dr. Tracey Parnell

123 NaProTECHNOLOGY Any Questions? Dr. Phil Boyle