Pharmological, Alternative Therapy and Fertility in Women`s Health

Report
Non-pharmacological, Holistic and
Alternative Therapy and Fertility in
Women’s Health
Julie A. Mickelson, MD
April 5, 2014
Acknowledgement
Dr. Richard Fehring,
Director Marquette Institute of NFP
Compadres
Objectives
• 1. Discuss how Natural Family Planning (NFP)
works and its historical development.
• 2. Describe the different methods of NFP and
evidence of their effectiveness.
• 3. Discuss challenges in the adoption and
acceptance of NFP and directions for the
future.
How Does NFP Work?
• Men are always fertile.
• Women are only fertile for a short time.
• If you don’t want to get pregnant, don’t have
sex on the fertile days.
• If you want to get pregnant have sex on the
fertile days.
How Does NFP Work?
• Monitor and interpret natural biological
markers of fertility.
• Define the fertile and infertile times of the
cycle.
• Use the information to avoid or achieve
pregnancy.
Advantages of NFP
• Non-pharmalogical :
Safe, no side effects
• Holistic:
Fertility is a gift, not a disease.
Shared method between the couple
Fits with moral, ethical, and spiritual beliefs
Can be used to avoid or achieve
• Therapeutic
Menstrual cycle the 5th vital sign
Identify and treat fertility problems
History of NFP 1920’s
• Ogino in Japan 1923
• Determined ovulation preceded menstruation
by 14 days
• Speculated life span of ovum 12-24 hours
• Life span of sperm 3-5 days
• Developed original calendar method of NFP
History of NFP 1930’s
• Knaus – Austria, Latz –U.S. (Chicago)
• “Rhythm” term coined by Latz
• Shortest cycle minus 19 days, start of fertile
window next day.
• Subtract shortest from longest and add 8 days
determines length of fertile window.
• Ex. 26d shortest, 30d longest : Fertile Window
day 8-19.
History of NFP 1950’s and 1960’s
• “Modern” Methods of NFP developed
• Roetzer and Keefe identified the basal body
temperature shift began to develop Symptothermal methods.
• Billings method developed based on cervical
mucus sign.
• Next two decades marked refinement and
dissemination of these methods.
History of NFP 1990’s
• NaPro Technology
Developed by Dr. Hilgers at the Pope Paul the
VI Institute in Omaha based on Creighton Model
of NFP
• Low Tech
Standard Days (Cycle Beads) and 2 day mucus
method developed at Georgetown
Chiapas
History of NFP “New Millenium”
• High Tech
Marquette Model developed by Dr. Fehring at
Marquette University.
Utilizes Clear Blue Fertility Monitor to measure
hormones directly
Biological Markers
•
•
•
•
Menstrual Cycle
Cervical Mucus
Basal Body Temperature
Urinary Hormones
29
Key Observations
• Estrogen causes cervical mucus production
• LH triggers ovulation and peak type mucus
• The corpus luteum produces progesterone
which dries up the mucus and causes the
temperature rise
An Introduction to NFP: Diocesan Development Program for NFP
Fehring, R., Kitchen, S., & Schivanandan, M (Ed. Notare T.) 2010.
Mucus Cycle
Beginning
Peak
End
Hormonal Fertility Monitors
ClearBlue Easy
Persona
Clearblue Fertility Monitor
• Low Fertility
• High Fertility
• Peak Fertility
The 6 day Window of Fertility
• Sperm live in cervical mucus for up to 5 days
• Egg lives 12-24 hours
• Confirmed by Wilcox et al NEJM -1995
1. 221 healthy women planning to get pregnant
2. Measured urine hormones to estimate day of
ovulation
3. Calculated probability of pregnancy of each day
relative to ovulation day.
4. Intercourse on only one day
The 6 day Window of Fertility
Day Relative to Ovulation
Probability of Pregnancy
-5
.08
-4
.17
-3
.08
-2
.36
-1
.34
0
.36
Markers of Fertile Window
• Beginning
1. Change in vaginal secretion
2. Estrogen rise in urine
3. Calendar double check calculation
• End
1. Change in vaginal secretion
2. Basal body temperature rise
3. LH surge
Variability of fertile window
1
2
3
4
5
6
7
8
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29
Fertile
Window
Fertile
Window
Fertile
Window
NFP Methods
• Mucus Based
1. Billings
2. Creighton
3. 2 day
•
•
•
•
Sympto-thermal – Couple to Couple, NW
Sympto-hormonal - Marquette
Calendar – Standard Days
Lactation Amenorrhea
Efficacy Definitions
• The perfect or correct use unintended pregnancy rate refers
to those pregnancies that occur when the method is used
consistently and according to instructions.
• The typical use pregnancy rate includes the combination of
unintended pregnancies when the methods are followed
correctly and the unintended pregnancies that occur when
users of the method do not always follow the instructions of
the method correctly.
• Difference between correct use and incorrect use gives
indication of how hard it is to use the method.
Billings Method
• Fertile period begins with onset of mucus or
sensation of vulvar dampness.
• Peak day last day of egg while mucus or
lubricative sensation.
• Avoid intercourse during menses.
• Have intercourse only on alternate dry days
prior to onset of fertile phase.
• Avoid intercourse during fertile days and until
evening of the 4th day past peak day.
Billings Method Efficacy
•
•
•
•
•
Indian Study, published in Contraception, 1996
2,059 Women from 5 states in India
21 month study
Correct Use 1%
Typical Use 10.5% at 12 months, 15.9% at 21
months
Creighton Model
• Standardized version of the Billings ovulation
method.
• Rigorous teacher training.
• Uniform recording system for vaginal
discharges.
Creighton Model Efficacy
• Howard and Stanford, Archives of Family
Medicine, 1999
• Observational Cohort 701 clients
• 18 months follow up
• Correct Use 3%, Typical Use 17%
• Most typical use pregnancies resulted from
deciding to achieve pregnancy or having
intercourse on a fertile day
NaPro Technology
• Cooperative and restorative reproductive
medicine.
• Charting is core of evaluation.
• Optimizing ovulation, mucus flow,
progesterone levels.
• Surgical correction of endometriosis
• Alternative approach to In Vitro Fertilization
2 Day Method
• Georgetown University
• Algorithm developed for women without regular
cycles.
• Analyzed cycles and probability of pregnancy.
• Did I see mucus today? Yesterday?
• If either answer is yes consider it a fertile day.
• If both no than it is an unfertile day.
• Especially helpful in low literacy
• Correct Use 3.5%, Typical Use 13.7%
Teacher Training
Vikings Fans are Everywhere
Sympto-thermal Method
• Start of fertile window identified by mucus
sign.
• End of fertile window defined by temperature
rise
• Double check adds calendar calculation to
start of fertile window and fertile window may
start before first day of mucus sign
Sympto-thermal Efficacy
• European Multicenter Study
• Published in Contraception in 1999
• Participants indicated pregnancy intention for
the next cycle
• Single check (mucus/temp)
214 women, typical use 8.5%
• Double check (calendar/mucus/temp)
1046 women, typical use 2.6%
Sympto-Hormonal Method
• Developed at Marquette University,
Marquette Model
• Clear Blue Fertility Monitor used to define
fertile window with double check of the
mucus sign.
• Urinary hormone testing is more precise in
estimating ovulation than mucus or
temperature.
Charting CM & HM
Cohort Comparison:
MM (N=307) vs. CM (N=312)
•
•
•
•
•
•
•
MM
Female = 28.4 (SD = 5.9)
CM
Female = 28.7 (SD = 5.8)
MM
Male =
30.3 (SD = 6.1)
CM
Male =
30.7 (SD = 6.0)
Correct Use: MM = 98.0 vs CM = 97.4
Typical Use:
MM = 87.5 vs CM = 77.2
Fisher Test: Greater portion of CM unintended
pregnancy = 3.57; p < 0.05 (28 vs 41)
Length of Fertility (N=1149)
• HM was 6.1 days (SD = 2.6)
• Mucus was 11.1 days (SD = 5.8)
• (t = 28.33, p < 0.000)
• (r = 0.18, p < 0.000)
11.1
6.1
Randomized Comparison of Two Internet
Supported Natural Family Planning
Methods
(Final Efficacy Results)
HHS Grant Funded Study
Specific Aims
•
•
•
To compare the efficacy in the use of two
internet-supported methods of NFP (i.e.,
EHFM and CMM) in aiding couples to avoid
pregnancy.
To compare the satisfaction and ease of use
in the use of two internet-supported
methods of NFP (i.e., EHFM and CMM).
To compare the mutual motivation in the
use of two internet-supported methods of
NFP (i.e., EHFM and CMM).
Perfect Use Efficacy
 The perfect use and total unintended pregnancy
rates of the two study groups are based upon
1,126 cycles of correct use and 2,780 total
cycles of use.
 The perfect use pregnancy rate per 100 women
over 12 months of use in the EHFM group was 0
for the monitor group and 2.7 for the mucus
group.
 There were no differences between the two
groups in perfect use pregnancy rates.
Net Unintended Pregnancy Rates
Correct Use
Monitor Mucus
Typical Use
Monitor
Mucus
N = 197
Pregnancies = 0
3 cycles:
0.00
6 cycles:
0.00
9 cycles:
0.00
12 cycles:
0.00
N=161
=3
0.97
0.97
0.97
0.97
N = 197
Pregnancies = 10
3 cycles:
0.97
6 cycles:
0.95
9 cycles:
0.94
12 cycles:
0.93
N=161
= 21
0.92
0.86
0.83
0.81
Std Error:
.016
Std Error:
.038
.00
.022
Standard Days
• CycleBeads plastic necklace
• Women often incorrectly identify what they believe are
days of fertility
• Fixed formula used to define fertile phase as day 8-19
for women with cycles between 26-32 days, (12 day
overlaps possible variation in actual 6 day window)
• Rubber ring to advance each day. Red bead first day of
menses. Brown infertile. White fertile.
• Simple to teach and learn, especially in low resource
setting
• Sold at Whole Foods
Standard Days Efficacy
• Arevalo, Jennings, Sinai Georgetown
University
• Formula developed using data from 7500
cycles with computer simulation.
• Days 8-19 maximal protection, minimal
abstinence
• 478 women from Peru, Bolivia, and Philippines
• Correct Use 4.75%, Typical Use 12%
Chiapas
Breastfeeding
• Difficult to identify fertility during transition to
regular cycles
• Can’t rely on temperature with little sleep
• Mucus may be continuous and confusing to
interpret
• Ovulation can happen before first menses
• High motivation to avoid pregnancy and often
frustration
Lactation Amenorrhea Method
•
•
•
•
Fully Breastfeeding
Less than six months after delivery
No vaginal bleeding after 56 days postpartum
2% chance of pregnancy if these three criteria
fufilled.
• Helps decrease amount of abstinence
required.
The Breastfeeding Protocol
•
•
•
•
•
•
•
Trigger a cycle by pushing the “M” button on the monitor.
Fast forward the monitor to day 5.
The next 20 days the monitor will ask for a test.
Test your first morning urine every other day.
When a “high” is recorded, test the urine every day.
Re-trigger the monitor and fast forward every 20 days.
Continue steps 1-6 until you detect a Peak reading and
resume menses.
• Intercourse instructions are:
• To avoid pregnancy, refrain from intercourse on High and
Peak days and three full days after the last Peak day.
R. Fehring, M. Schneider, & M.L. Barron, (2005) “Protocol for determining
fertility while breast-feeding,” Fertility and Sterility 84: 805-7. (N=10; Fertility
monitor + mucus).
Correct Use Pregnancies
• There were 2 unintended pregnancies per
100 women with correct use during the first
12 months postpartum.
• The method-related pregnancies occurred in:
(i) the amenorrheic period (in the 9th month
postpartum), (ii) the 3rd cycle after the
return of menses (in the 12th month
postpartum).
Typical use survival over 12-months
Months Women
Cumulative
Exposed
pregnancy rate
1
198
0
3
138
0
6
117
0
12
74
8
Factors in NFP Effectiveness
•
•
•
•
•
Personalized Instruction
Well trained teachers
Motivation
Communication by couple
All methods have similar correct use
effectiveness.
• What you learn depends on what is available
in your area (or online).
Pregnancy rate over one year by family
planning method
Correct Use










CHANCE
SPERMICIDES
WITHDRAWAL
OVULATION METHOD
CONDOMS
SDM
Marquette Method
SYMPTOTHERMAL
PILL
IUD
85
18
4
3
2
5
0.6-2
0.4-2
0.3
0.1
Typical Use
85
29
27
19(25)*
15
12
7 - 12
8 - 11
8
0.6
*Adapted from: Trussell J. Contraceptive failure in the United States.
Contraception. 2004;70:89-96.
Typical Use
• The disconnect: Our critics focus on typical use while
we focus on perfect use
• NFP is inherently different from other methods since it
can be used to achieve and is instantaneously
reversible. NFP is “Unforgiving” per Trussell.
• The longer the estimated fertile window, the better the
perfect use. Does this longer fertile window and longer
abstinence period contribute to higher pregnancy
rates?
• The key concept is motivation and identification of
intentions to avoid or achieve at the beginning of each
cycle.
Pregnancy Rate by Motivation Level
High (N = 298)
Pregnancies = 14
# Rate
3 months: 2 99.2 .01
6 months: 2 98.0 .01
9 months: 4 96.0 .02
12 months: 6 91.6 .02
Rate:
8/100
Low (N = 60)
Pregnancies = 30
#
Rate
7
86.9 .05
4
78.0 .06
6
62.4 .07
13 25.0 .08
75/100
Bias in the Literature
• Trussell: “Contraceptive Failure in the U.S”. 2011
• Typical use of fertility awareness based methods 24%
• Designated as less effective than condoms and
withdrawal
• Results derived from National Survey of Family Growth
• Self-reported, random sample 7,000 (approx. 50 FABM
users)
• Perfect use data correctly identified for different FABM,
but typical use lumped all together
• His work is considered “authoritative”
Challenges in the Adoption of NFP
• Reality: Only 0.1% of all women in U.S. use NFP
and only 0.2% of Catholic women
• Few physicians understand NFP, fewer would
recommend and some are even hostile
• Why?
1.
2.
3.
4.
5.
Ignorance of modern methods of NFP
Perception that it is not effective
Difficulty with Abstinence
Find methods cumbersome to learn and practice
Counter cultural to contraceptive mentality /sexual
revolution
Strategies
Education and Evangelization
• Users
1. Grassroots
2. Fertility Awareness for Young Women
3. Faith Formation
• Students
1. Incorporate into women’s health curriculum
2. Lectures/presentations
• Physicians
1. Physician to physician
2. Better science
Strategies
Collaboration
• Representatives of all methods should work
together to advance NFP
• FACTS Fertility Awareness Collaborative to
Teach the Systems
• Recognize that not every method is perfect for
every user
Strategies
Improve the Methods
•
•
•
•
Quicker and easier to learn
Less confusion
Easy Access/Internet/Smart Phones
Less Abstinence
Bibliography
• M. Arevalo et al “Efficacy of a new method of family
planning: the Standard Days Method,” Contraception 65
(2002) 333-338.
• M. Arevalo et al ”Efficacy of the new TwoDay Method of
family planning,” Fertility and Sterility 82 (2004) 885-892.
• R. Fehring, “Efficacy and efficiency in natural family
planning services,” Linacre Quarterly 76(1) (2009) 9-24.
• R. Fehring, “Perfect, typical, and imperfect use of natural
family planning methods, the problems of a biased
approach to research and the realistic needs for improved
studies,” Linacre Quarterly 78 (2011) 467-473.
Bibliography
• R. Fehring et al, “Protocol for determining fertility while
breastfeeding and not in cycles,” Fertility and Sterility 84
(2005) 805-7.
• R. Fehring et al, “Randomized comparison of two Internetsupported fertility-awareness-based methods of family
planning,” Contraception 88 (2013) 24-30.
• G. Freundl, “European multicenter study of natural family
planning (1989-1995): efficacy and drop-out,” Advances in
Contraception 15 (1999) 69-83.
• B. Gross, “Is the lactational amenorrhea method a part of
natural family planning? Biology and policy,” American
Journal of Obstetrics and Gynecology 165 (1991) 2014-9.
Bibliography
• M. Howard and J. Stanford, “Pregnancy probabilities during use of
the Creighton Model Fertility Care System,” Archives of Family
Medicine 8 (1999) 391-402.
• Indian Council of Medical Research Task Force on Natural Family
Planning “Field trial of Billings ovulation method of natural family
planning,” Contraception 53 (1996) 69-74.
• M. Manhart, et al “Fertility awareness-based methods of family
planning: A review of effectiveness for avoiding pregnancy using
SORT,” Osteopathic Family Physician 5 (2013) 2-8.
• J. Trussell, “Contraceptive failure in the United States,”
Contraception 83 (2011) 397-404.
• A. Wilcox et al, “Timing of sexual intercourse in relation to
ovulation, Effects on the probability of conception, survival of the
pregnancy, and sex of the baby,” The New England Journal of
Medicine 333 (1995) 1517-21.
Thank you/Gracias!

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