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Creighton Model FertilityCare System
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| Creighton Model / FertilityCare | |
|---|---|
| Background | |
| Type | Behavioral |
| First use | 1980 |
| Failure rates (first year) | |
| Perfect use | 0.5%[1] |
| Typical use | 3.2%[1] |
| Usage | |
| Reversibility | Immediate |
| User reminders | Accurate instruction & daily charting are key. |
| Clinic review | None |
| Advantages and disadvantages | |
| STI protection | No |
| Period advantages | Prediction |
| Weight gain | No |
| Benefits | Low direct cost; no side effects; in accord with Catholic teachings; may be used to aid pregnancy achievement |
The Creighton Model FertilityCare System (Creighton Model, FertilityCare, CrMS) is a form of natural family planning which involves identifying the fertile period during a woman's menstrual cycle. The Creighton Model was developed by Thomas Hilgers, the founder and director of the Pope Paul VI Institute. This model, like the Billings ovulation method, is based on observations of cervical mucus to track fertility. Creighton can be used for both avoiding pregnancy and achieving pregnancy.
Conceptual basis
[edit]Hilgers describes the Creighton Model as being based on "a standardized modification of the Billings ovulation method (BOM)", which was developed by John and Evelyn Billings in the 1960s.[2] The Billingses issued a paper refuting the claim that the CrMS represents a standardization of the BOM. According to the Billingses said that those concepts are two different methods and should not be seen as interchangeable.[3]
Effectiveness
[edit]For avoiding pregnancy, the perfect-use failure rate of Creighton was 0.5%, which means that for each year that 1,000 couples using this method perfectly, that there are 5 unintended pregnancies. The typical-use failure rate, representing the fraction of couples using this method that actually had an unintended pregnancy, is reported as 3.2%.[1][4]
For achieving pregnancy, no large clinical trials have been performed comparing ART and NaProTechnology. Only observational one-arm studies have been published so far.[5][6][7] In the larger of these three studies, 75% of couples trying to conceive received additional hormonal stimulation such as clomiphene.[5]
References
[edit]- ^ a b c Hilgers, TW; Stanford, JB (1998). "Creighton Model NaProEducation Technology for avoiding pregnancy. Use effectiveness". The Journal of Reproductive Medicine. 43 (6): 495–502. PMID 9653695.
- ^ Creighton Model
- ^ Some Clarifications Concerning NaProTECHNOLOGY and the Billings Ovulation Method Archived 2007-09-28 at the Wayback Machine
- ^ Pallone, S. R.; Bergus, G. R. (2009). "Fertility Awareness-Based Methods: Another Option for Family Planning". The Journal of the American Board of Family Medicine. 22 (2): 147–157. doi:10.3122/jabfm.2009.02.080038. PMID 19264938. S2CID 26459027.
- ^ a b Stanford, J. B.; Parnell, T. A.; Boyle, P. C. (2008). "Outcomes From Treatment of Infertility With Natural Procreative Technology in an Irish General Practice". The Journal of the American Board of Family Medicine. 21 (5): 375–84. doi:10.3122/jabfm.2008.05.070239. hdl:10379/13999. PMID 18772291.
- ^ Tham, Elizabeth; Schliep, Karen; Stanford, Joseph (2012). "Natural procreative technology for infertility and recurrent miscarriage: outcomes in a Canadian family practice". Canadian Family Physician. 58 (5): e267–74. PMC 3352813. PMID 22734170.
- ^ Stanford, Joseph B.; Carpentier, Paul A.; Meier, Barbara L.; Rollo, Mark; Tingey, Benjamin (2021). ""Restorative reproductive medicine for infertility in two family medicine clinics in New England, an observational study"". BMC Pregnancy and Childbirth. 21 (1): 495. doi:10.1186/s12884-021-03946-8. PMC 8265110. PMID 34233646.
Further reading
[edit]- Hilgers, Thomas W., M.D., The NaPro Technology Revolution: unleashing the Power in a Woman's Cycle. New York: Beaufort Books, 2010. Print.
- Hilgers, Thomas W. The Medical & Surgical Practice of NaProTECHNOLOGY. Omaha: Pope Paul VI Institute, 2004. N. pag. Print.
- Moore, Keith L., T, V.N Persaud, and Mark G. Torchia. Before we are Born Essentials of Embryology and Birth Defects. 8th ed. Philadelphia: Elsevier Inc., 2013. Print.
- Unleashing the Power of a Woman's Cycle. Pope Paul VI Institute, 2006. Web. 14 Nov. 2012. <http://www.naprotechnology.com/index.html Archived 2012-06-16 at the Wayback Machine>.
- Jemelka, B. E., & Parker, D. W., & Mirkes, R. (2013). «NapProTECHNOLOGY and Conscientious OB/GYN Medicine». American Medical Association Journal of Ethics, 15.
- Hilgers, T. W. (2011). The New Women’s Health Science of NaProTECHNOLOGY. Archives of Perinatal Medicine, 17(4). Retrieved from https://web.archive.org/web/20150824051921/http://fertilitycare.net/documents/APM174-2-Hilgers.pdf
- Stanford, J. B.; Parnell, T. A.; Boyle, P. C. (2008). "Outcomes From Treatment of Infertility With Natural Procreative Technology in an Irish General Practice". The Journal of the American Board of Family Medicine. 21 (5): 375–84. doi:10.3122/jabfm.2008.05.070239. hdl:10379/13999. PMID 18772291.
- Hilgers, TW; Stanford, JB (1998). "Creighton Model NaProEducation Technology for avoiding pregnancy. Use effectiveness". The Journal of Reproductive Medicine. 43 (6): 495–502. PMID 9653695.
- Lora, José María Murcia; Martínez, Oscar Martínez; Simoni, Jennifer; Calvo, Marian Martínez; Andrés, Alberto Falces de; Mejía, Jorge Enrique; Simoni, Diglio; Alcázar, Juan Luis (2022). "Fertile window and biophysical biomarkers of cervical secretion in subfertile cycles: a look at biotechnology applied to NaProTechnology". Clinical and Experimental Obstetrics & Gynecology. 49 (1): 17. doi:10.31083/j.ceog4901017.
External links
[edit]Creighton Model FertilityCare System
View on Grokipediafrom Grokipedia
History and Development
Early Research and Foundations (1970s-1980s)
In 1976, Thomas W. Hilgers, then a medical resident at St. Louis University School of Medicine, initiated research into vulvar discharge patterns as external indicators of cervical mucus changes during the menstrual cycle, aiming to standardize observations for fertility tracking. This work built upon earlier methods like the Billings Ovulation Method, which relied on subjective mucus assessments, by emphasizing objective, teachable criteria for women's self-observations of mucus type, sensation, and appearance at the vulva. Hilgers' investigations correlated these external biomarkers with internal cervical mucus evaluations obtained via speculum examination, establishing foundational protocols for identifying fertile and infertile phases based on estrogen-driven mucus production peaking before ovulation.[11] By 1978, Hilgers had contributed to reviews of ovulation method research, synthesizing data from clinical trials that demonstrated women's vulvar observations as reliable proxies for cervical events, with inter-observer agreement rates exceeding 90% in controlled studies. A pivotal 1979 study co-authored by Hilgers and Ann M. Prebil, published in Obstetrics & Gynecology, directly validated the method's accuracy by comparing 1,200 cycles of women's self-reported vulvar mucus observations against physician-assessed internal os mucus samples, finding a correlation coefficient of 0.92 for peak mucus days indicating ovulation. This empirical foundation underscored the causal link between observable mucus transitions—dry to sticky to clear and stretchy—and hormonal shifts, enabling precise charting without invasive procedures.[12][13] The Creighton Model emerged from these efforts, first fully described in 1980 as a standardized system incorporating bleeding patterns alongside mucus observations to define a "base infertile pattern" for irregular cycles, breastfeeding, or perimenopause. During the early 1980s, Hilgers refined teaching protocols through pilot programs, achieving method effectiveness rates of 98.7% for avoiding pregnancy in initial user cohorts tracked via standardized Creighton charts. This period laid the groundwork for institutional adoption, with Hilgers' relocation to Creighton University in Omaha, Nebraska, prompting the model's naming and further validation studies correlating charts with ultrasound and hormone assays, confirming ovulation prediction accuracy within 1-2 days.[14]Institutional Establishment and Expansion (1990s-Present)
In the 1990s, the Pope Paul VI Institute for the Study of Human Reproduction, founded in 1985 by Thomas W. Hilgers, MD, expanded its focus on the Creighton Model FertilityCare System (CrMS) through enhanced research, education, and clinical services, integrating it with emerging protocols for natural reproductive medicine.[15] This period saw the institute's growth in training allied health professionals and physicians to teach CrMS, emphasizing standardized observation of fertility biomarkers for both family planning and gynecological diagnostics.[15] By the late 1990s, institutional efforts shifted toward broader dissemination, culminating in the establishment of structured networks to support practitioner certification and service delivery. FertilityCare Centers International (FCCI) was founded in 1999 to coordinate global promotion of CrMS and associated NaProTECHNOLOGY treatments, fostering an affiliate program for local FertilityCare Centers worldwide.[16] This organization standardized education and ensured alignment with life-affirming principles, enabling expansion into regions including Europe, Asia, Australia, Mexico, South America, and Canada.[17] Complementing this, FertilityCare Centers of America (FCCA) developed rigorous training pathways, including phased education programs and supervised practicums, to certify practitioners and establish affiliated centers across the United States.[9] By the 2010s, the practitioner network had grown substantially, with the American Academy of FertilityCare Professionals (AAFCP) reporting over 600 members globally by the 2020s, comprising CrMS instructors and supporters.[18] Educational programs accredited by AAFCP extended overseas, adapting CrMS instruction for diverse cultural contexts while maintaining protocol fidelity.[19] The Saint Paul VI Institute (renamed in 2018 following the canonization of Pope Paul VI) continued facility and program expansions in Omaha, Nebraska, solidifying its role as the central hub for CrMS research and advanced reproductive care.[15] This institutional framework has sustained CrMS adoption, with services now available through hundreds of centers and practitioners emphasizing empirical fertility tracking over contraceptive alternatives.[17]Core Principles and Methodology
Fertility Biomarkers and Observation
The Creighton Model FertilityCare System identifies fertility through standardized external observations of biological markers, primarily cervical mucus discharge and bleeding patterns, which reflect hormonal changes in the reproductive cycle. Cervical mucus serves as the principal biomarker, produced by cervical crypts under estrogen influence, with its characteristics evolving from minimal or absent discharge in the infertile phase to more abundant, fertile-quality mucus near ovulation. Bleeding observations, including menstrual flow, spotting, or intermenstrual events, provide additional markers of cycle phases, such as progesterone withdrawal or ovulatory confirmation. These biomarkers enable precise tracking without internal examinations, devices, or basal body temperature measurements.[14][4] Observations occur externally at the vulva multiple times daily, typically during every bathroom visit for urination or defecation, by wiping from front to back with white, unscented toilet tissue before and after elimination. Women note the dominant sensation (e.g., dry, moist, slippery) and visual qualities of any discharge (e.g., color, consistency, stretchability), discarding less fertile signs in favor of the most prominent fertile indicator encountered that day. This protocol emphasizes consistency and objectivity, with mucus classified into categories such as dry (no mucus), tacky or sticky (low fertility), creamy or cloudy (transitional), and peak-type (clear, stretchy, egg-white-like with slippery sensation, signaling high fertility). Bleeding is recorded by intensity and color, distinguishing routine menses from atypical patterns that may warrant medical review.[20][21][14] The method's reliance on these observable biomarkers allows for real-time fertility appraisal, with peak mucus typically preceding ovulation by 24-48 hours, corroborated by studies validating mucus patterns against ultrasound-confirmed ovulation. Absence of peak mucus or irregular bleeding can signal underlying issues like hormonal imbalances, informing diagnostic applications. Instruction from certified practitioners ensures accurate classification, as subjective interpretations are minimized through standardized terminology and charting stamps.[22][23]Charting and Interpretation Protocols
The Creighton Model FertilityCare System (CrMS) employs a standardized protocol for observing and recording cervical mucus and bleeding as primary biomarkers of fertility. Women perform external observations by wiping the vulvar area with toilet paper each time they void urine or a bowel movement, noting the presence, sensation (e.g., dry, moist, slippery), color, consistency, and stretchability of any discharge before any wiping that might alter it.[14][4] These observations occur prospectively throughout the day, with the final evaluation at the end of each cycle day to ensure accuracy without influence from intercourse.[3] Bleeding patterns, including spotting or intermenstrual flow, are also recorded to distinguish menstrual from ovulatory or pathological events.[14] Charting utilizes a specialized NaProTRACK™ diary or CrMS chart, where users stamp or code daily observations using predefined symbols: small circles or stamps denote dry/infertile states (e.g., no sensation or sticky/tacky mucus), while progressively larger or colored stamps (often yellow for transitional, green for fertile) represent changing mucus qualities, accompanied by precise verbal descriptions like "clear, stretchy, slippery."[20][14] Changes in pattern are marked with arrows to highlight transitions, and bleeding intensity is noted as heavy (H), moderate (M), light (L), or spotting.[20] Charts are reviewed in follow-up sessions with certified FertilityCare™ practitioners, who provide individualized feedback; self-interpretation without training is discouraged due to the need for precise standardization to avoid errors.[3][1] Interpretation protocols identify the fertile window based on mucus progression: infertile phases occur pre-ovulation (dry or basic mucus) and post-ovulation (after three consecutive dry days following the Peak Day), while the fertile phase spans from the first sign of changing mucus until the end of Peak mucus.[14] The Peak Day is defined as the last day of fertile-type mucus exhibiting clarity, stretchiness (up to 2 inches or more), and lubricative sensation, correlating with ovulation typically 0-2 days later, validated by ultrasound and hormone studies showing 98.8% accuracy when properly charted.[24][25] For avoiding pregnancy, abstinence is required from the onset of fertile mucus through Peak Day +3 (or until dry sensation returns), yielding method effectiveness of 96.8-99.5% with correct use.[3] For achieving pregnancy, intercourse is recommended every other day during fertile mucus, peaking around Peak Day -2 to Peak Day.[3] Abnormal patterns, such as erratic bleeding or absent Peak mucus, prompt medical referral for diagnostics like progesterone assays, emphasizing the system's dual role in family planning and health monitoring.[14][25]Efficacy for Family Planning
Effectiveness in Avoiding Pregnancy
The Creighton Model FertilityCare System (CrMS) demonstrates high effectiveness in avoiding pregnancy when used correctly, with method effectiveness rates—reflecting perfect adherence to protocol—reported at 98.8% to 99.5% over 12 to 18 months in prospective studies involving standardized teaching and follow-up.[26][8] A 1998 meta-analysis of five studies encompassing 1,876 couples and 17,130 couple-months found method effectiveness of 99.5% at both 12 and 18 months, based on protocol-defined fertile windows abstained from without errors.[26] Use effectiveness, accounting for typical adherence including user or instructor errors, ranges from 96.4% to 98.0% in the same datasets, with unintended pregnancy probabilities of 2.0% to 3.6% over 12 months among motivated users receiving individualized instruction.[26][8] In a 1980s cohort of 701 couples followed for typical use, the 12-month pregnancy rate was 17.12 per 100 couples intending avoidance, but disaggregation revealed most incidents stemmed from achieving-pregnancy behaviors (12.84 per 100) or rare user/teacher errors (<3 per 100), with only one method failure; rates were lower (13.98 per 100) for women with uncomplicated cycles.[7] Effectiveness depends on factors such as consistent biomarker observation, protocol compliance, and quality of practitioner-led training, which mitigates errors in interpreting cervical mucus and bleeding patterns.[26] Studies primarily involve self-selected participants, often from religious or fertility-motivated demographics with high motivation for abstinence during fertile phases, potentially inflating real-world rates compared to broader populations; discontinuation due to non-compliance was 11-12% over 18 months.[26] Limited large-scale independent randomized trials exist, though available data from protocol-specific research indicate superior avoidance outcomes relative to less structured fertility awareness methods.[7]| Study | Sample Size | Duration | Method Effectiveness (Avoiding) | Use Effectiveness (Avoiding) | Key Notes |
|---|---|---|---|---|---|
| Hilgers et al. (1998 meta-analysis) | 1,876 couples | 12-18 months | 99.5% | 96.8% (12 mo), 96.4% (18 mo) | Aggregates five U.S. studies; low discontinuation (11-12%).[26] |
| Hilgers & Stanford (1994) | 242 couples | 12 months | 98.8% | 98.0% | 1,793 couple-months; continuation 78%.[8] |
| 1983-1989 cohort (reviewed 2024) | 701 couples | 12-18 months | Not specified | 82.9-78.7% effective (implied from 17-21% pregnancy rate) | Includes behavior-related pregnancies; lower errors in regular cycles.[7] |
Effectiveness in Achieving Pregnancy
A prospective study of 242 couples using the Creighton Model reported a use effectiveness of 24.4% for achieving pregnancy, reflecting real-world application where fertile days were targeted for intercourse.[6] This figure aligns with typical per-cycle conception rates for normally fertile couples aged 20-30, where natural fertility yields approximately 20-25% success per menstrual cycle.[6] In the Creighton Model Effectiveness, Intentions, and Behaviors Assessment (CEIBA) study involving 296 couples followed for up to 13 cycles, correct use to conceive—defined as intercourse limited to peak-type mucus days—resulted in a cumulative pregnancy rate of 89.6%.[27] Couples intending to conceive overall achieved 88.0-89.8% cumulative rates over the same period, indicating the model's utility in identifying the narrow fertile window (typically 5-7 days per cycle) to optimize timing without medical aids.[27] These outcomes were observed among users initially trained for family planning, with high adherence linked to structured instruction by certified practitioners.[27] Such rates presume no underlying subfertility; for couples with normal reproductive health, fertility awareness methods like Creighton yield conception probabilities of 85-90% within 6 months via targeted intercourse.[10] Limitations include reliance on accurate biomarker observation and couple motivation, with incomplete data on intercourse timing potentially underestimating efficacy in broader populations.[27] Continuation at 12 months in early studies reached 78%, supporting sustained use for achievement goals.[6]Medical and Therapeutic Applications
Integration with NaProTechnology
NaProTechnology, or Natural Procreative Technology, represents a medical application of the Creighton Model FertilityCare System (CrMS), utilizing its standardized charting of cervical mucus observations and menstrual bleeding patterns to diagnose and treat underlying reproductive and gynecological disorders. Developed by obstetrician-gynecologist Thomas Hilgers in the late 1970s and formalized over subsequent decades at the Pope Paul VI Institute for the Study of Human Reproduction, NaProTechnology interprets CrMS biomarkers—such as mucus type, quantity, and sensation—to identify hormonal imbalances, ovulatory defects, and structural issues that contribute to infertility, recurrent miscarriage, polycystic ovary syndrome (PCOS), and conditions like premenstrual syndrome (PMS) or abnormal uterine bleeding.[28][29] This integration shifts from symptomatic suppression (as in hormonal contraceptives) to targeted, cycle-cooperative interventions that restore natural fertility potential.[30] In practice, women trained in CrMS maintain daily charts, which are reviewed by certified practitioners and NaPro-trained physicians to time diagnostic tests, such as serum progesterone levels during the luteal phase or ultrasounds aligned with peak mucus days. Treatments may include corrective hormone supplementation (e.g., progesterone for luteal phase deficiency, identified in up to 62% of cases in one cohort), ovulation induction with medications like clomiphene citrate, or laparoscopic surgery for endometriosis or tubal adhesions.[29] Unlike in vitro fertilization (IVF), which bypasses natural processes, NaProTechnology prioritizes etiology-based correction, avoiding embryo manipulation or multiple gestations; a retrospective study of 108 infertile couples reported a crude live birth rate of 38% and an adjusted cumulative rate of 66% at 24 months, with all births singletons and low complication rates.[29] Success often occurs without intervention in 24% of cases via timed intercourse alone, rising to 69% with medical NaPro protocols.[29] This framework has been applied in general practices and specialized centers, yielding outcomes comparable to or exceeding those of assisted reproductive technologies in select populations, though studies note limitations like small sample sizes and potential self-selection among motivated users.[29] By leveraging CrMS data for longitudinal monitoring, NaProTechnology enables ongoing adjustments, such as prematurity prevention through progesterone therapy in high-risk pregnancies, addressing root causes rather than fertility postponement.[30]Diagnostic and Treatment Outcomes
The Creighton Model FertilityCare System facilitates diagnosis of gynecological conditions through standardized observation of cervical mucus biomarkers and menstrual patterns, which reveal deviations indicative of underlying issues such as anovulation, luteal phase defects, or hormonal imbalances. These charts enable practitioners to identify abnormalities not readily apparent via standard ultrasounds or blood tests alone, with reliability demonstrated in challenging cases including irregular cycles, breastfeeding, and premenopause.[31] In NaProTechnology applications, diagnostic protocols using Creighton charting have identified multiple concurrent disorders in subfertile couples, including ovulation-related issues in 87% of cases, endometriosis in 31%, and nutritional deficiencies in 47%, averaging 4.7 diagnoses per couple.[32] Treatment outcomes integrated with NaProTechnology, which employs Creighton diagnostics to guide targeted medical and surgical interventions, show varied success in addressing infertility and recurrent miscarriage. A retrospective Canadian study of 108 couples reported a crude live birth rate of 38% and an adjusted cumulative rate of 66% at 24 months, with all births being singletons and 78% achieving birth weights over 2500 grams.[29] Similarly, the International Natural Procreative Technology Evaluation and Surveillance (INPTEA) study of 643 subfertile couples found 57% achieved at least one pregnancy and 44% a live birth, often following procedures like laparoscopy informed by Creighton-based diagnostics.[32] These rates compare favorably to some IVF cohorts (around 50% live births after one year), though study designs are primarily retrospective and practitioner-led, limiting generalizability.[29] For specific gynecological disorders, NaProTechnology treatments prompted by Creighton diagnostics have addressed conditions like ovarian cysts, heavy bleeding, and premenstrual syndrome through hormone therapies or surgery, though peer-reviewed outcome data on resolution rates remain limited to institutional reports rather than large randomized trials. In recurrent miscarriage subsets, the Canadian cohort showed sustained live births without increased multiples, contrasting with assisted reproductive technologies' higher twinning risks.[29] Overall, success correlates with younger age, absence of prior assisted reproduction, and early intervention on identified causes, emphasizing restorative approaches over empirical symptom management.[33]| Study | Sample Size | Live Birth Rate | Key Notes |
|---|---|---|---|
| Canadian Family Practice (2000-2006)[29] | 108 couples | 38% crude; 66% cumulative adjusted at 24 months | Retrospective; included infertility and miscarriage; singletons only |
| INPTEA (international, up to 2022)[32] | 643 couples | 44% | Multiple diagnoses per couple; 22% underwent surgical procedures |