Catholic Health Care Advocates Papers
NATURAL PROCREATIVE TECHNOLOGY (NAPROTECHNOLOGY) FOR INFERTILITY: AN OPPORTUNITY FOR CATHOLIC HOSPITALS
Mary L. Davenport, MD, FACOG
Catholic health care has too long allowed itself to be portrayed as denying reproductive health care options. There has been too much emphasis on the non-provision of contraception and sterilization services, which are widely available elsewhere in most of the United States. Hospital administrators maintain a posture of apologizing for what their hospitals don't do. Recently when a Catholic hospital network took over a community hospital in Northern California, the hospital spokesman defensively stated, "It is not our intention to squeeze out women's health care," [1] when challenged by members of the press and local medical community.
Instead of apologizing for denying options, Catholic health care institutions should have a broader vision of providing superior reproductive health care. One possibility is using natural family planning (NFP) to enhance medical and surgical therapies for infertility, thereby providing low cost and effective treatments for the community. By providing something better, Catholic hospitals can be celebrated for being different, instead of apologizing for it. Although many Catholic hospitals have developed natural family planning services as an alternative to artificial contraception for avoiding pregnancy, very few have realized the potential of NFP for the diagnosis of infertility problems and improvement of fertility therapies.
Infertility is an extremely prevalent medical problem and, according to many observers, has been rising over the past few decades. The incidence of involuntary infertility worldwide is 16.7% as reported to health services [2] and 26.1 % when calculated from demographic data.[3] This represents 90 million women in the world.[4] In estimates of infertility among couples, male infertility ranges from 26.2% to 46.6%.[5] Some epidemiologists believe there has been a worldwide decline in male fertility and semen quality over the past fifty years or more.[6] In the United States in 1995, ten percent of women of reproductive age (6.1 million) have impaired fecundity. The fastest rising demographic category is women with impaired fecundity with no children in the 35-44 year-old age group, which increased 65% from 1988-1995. [7]
The typical infertility patient in the United States is a married woman in her early to mid-thirties who has been attempting to achieve a pregnancy for at least one year. In the U.S., the woman most frequently makes the healthcare decisions for the family and initiates care, with the husband following her lead. She is typically fairly affluent, being part of a dual-income couple and having postponed childbearing. She is likely to be one of the 50% of women with subfertility who has used oral contraceptives. Because of deplorable demographic realities in contemporary society, she may have had one or more abortions, one or more sexually transmitted diseases, probably has engaged in premarital sex, and may have cohabited with her husband prior to marriage. She may be one of the 100,000,000 Americans who consults alternative health care practitioners or is a consumer of herbs and nutritional supplements[8] The infertility services she needs are frequently not covered by medical insurance. She needs ethical, efficacious, costeffective diagnosis and therapy for her fertility problem.
A typical couple with a fertility problem is likely to be attracted to a method which cooperates with the woman's natural reproductive cycles and achieves pregnancy through marital intercourse. Although they may be unaware of it, the woman and her husband may be desperately in need of emotional and spiritual healing from their past sexual and reproductive practices, as well as physical diagnosis and therapy of the problems causing infertility. This couple and millions like them present an unprecedented opportunity for Catholic healthcare services.
The organization of mainline fertility services and the training of physicians in the U.S. in this field is inadequate. The typical fertility patient consults an obstetrician-gynecologist who probably has not been trained in self-monitored fertility awareness, as is common to all methods of NFP, and does not know how effective timed intercourse can be in helping subfertile couples achieve pregnancy, especially at the time of maximum fertility. Her physician most likely has not been taught anything about the normal physiology of cervical secretions and their effect on fertility,[9] and may possess only rudimentary knowledge of the physiology and endocrinology of the normal and abnormal menstrual cycle, as they relate to self-monitoring for fertility. An infertility patient is likely to be put on clomiphene, the initial fertility drug of choice, at too high a dose. As a direct result of the drug, her cervical secretions may be dried up. The woman's physician may perform a diagnostic laparoscopy and, if she is found to have endometriosis (a common condition in infertility patients), the physician may place her on suppressive drugs which further delay attempts at conception for several more months. Although this is usually inferior therapy for infertility caused by endometriosis, it is commonly done because her surgeon has not been adequately trained in the surgical treatment of endometriosis, and because of aggressive marketing of suppressive drugs by pharmaceutical companies. [10]
When these therapies fail, an infertility patient will then be referred to a reproductive endocrine subspecialist, who, unfortunately, may not have the desire or training to help her and her husband achieve pregnancy by systematically diagnosing and treating their pathology. Recent articles in medical journals have actually denigrated a diagnostic workup to find the cause of infertility.[11] The infertility specialist may have spent most of his training in the techniques of assisted reproductive technology (ART), in which conception takes place in the laboratory, rather than learning the advanced surgical techniques to repair damage to the female reproductive tract. The latest conference of the American Society for Reproductive Medicine in Toronto, September, 1999, which reflects the interests and training of the obstetrician-gynecologists who are subspecialists in infertility and graduates of reproductive endocrinology (RE) training programs, revealed only a minority (32% or 237 out of 719) of papers on basic research in reproductive physiology and diagnosis and treatment of the primary disease processes causing male and female infertility. The vast majority of the remainder were on assisted reproductive technology techniques (ART).
Although originally developed for the improvement of livestock in veterinary medicine, and long thought to be unsuitable for humans, the use of ART has exploded since the birth of the first baby conceived by IVF (in vitro fertilization) in 1978. Because of the orientation and training of the woman's fertility doctor, the infertile couple will likely be offered IVF or other permutations of ART such as GIFT and ZIFT.[12] The couple will pay $1200 to $5000 (an average of $2250) for medication for controlled ovarian hyperstimulation (COH),[13] the goal of which is to produce as many eggs as possible for harvesting and for future cycles. Because of the high probability that her first cycle of treatment of ART will fail, an excess of eggs is needed. If the woman is employed, she will not be able to work during cycles of fertility therapy, because taking the medication, laboratory and ultrasound monitoring of her cycle, harvesting her ova, and the implanting of embryos, is a full time occupation. If her husband's sperm count is low, ICSI (intracytoplasmic sperm injection) will be suggested. [14] ICSI adds an additional cost of approximately $1200 to the IVF cycle;[15] although it improves the pregnancy rate only 5.7%, from 21.5% to 27.2 %, per retrieval. [16] If the woman is over 40 or her husband's sperm has a low count or motility, the couple will be offered IVF cycles with donated sperm or ova; donated ova from fertile women in their 20's and donated sperm can increase the "success" rate in these situations. Although donated semen costs only about $200[17] the cost of donated ova is $7500-$8000 or more. [18]
If the couple achieves pregnancy, they will be exposed to a 29.2 % rate of multiple births due to transfer of multiple embryos in IVF, [19] and a 20.2 % rate of poor pregnancy outcomes such as miscarriage, ectopic pregnancy, or stillbirth,[ 20] as well as the practices of embryo destruction, cryopreservation, and fetal reduction. Routine ART practices in the U.S., such as transfer of more than three embryos into the uterus, fetal reduction, and use of sperm and ova from donors, are actually illegal in some European nations. An added travesty of all of this is the lack of regulation of U.S. fertility clinics and their techniques.
Even though our couple may find these procedures repellent, they may submit to them because of their desire for a child. They may mortgage their house, take money from their retirement fund, or go deeply into debt to undergo these procedures, at a cost of $6100-$20,000 per cycle [2l]even though the live birth rate per cycle of treatment is only 19.6% or less. [22] It usually will take three to six cycles to achieve a pregnancy, if the couple has the financial and emotional resources to persist in this type of fertility treatment. They may not have been adequately counseled about other options. Infertile couples are in desperate need of a viable alternative.
A successful alternative to ART for infertility exists, which cooperates with natural reproductive mechanisms and functions. The term Naprotechnology, referring to the natural procreative technologies, was developed by Dr. Thomas Hilgers of the Pope Paul VI Institute to describe this type of treatment. It includes the charting of natural biological markers in a woman's reproductive cycle to interpret the natural phases of fertility, as well as the medical and surgical therapies that treat the underlying problem causing the infertility.[23] Pregnancy is achieved in Naprotechnology through normal intercourse. Substantial research at the Pope Paul VI Institute, much of it yet to be published, attests to the good results that can be achieved when the observation of biomarkers through self-monitoring of the reproductive cycle, and fertility focused intercourse (FFJ) are used. When FFI is combined with medical and surgical therapies excellent results are obtained that are in many instances superior to those of ART. In a study of couples with apparently normal fertility utilizing the Creighton method of charting with FFI, 90% achieved pregnancy after three months and 100% after seven months. [24 ] Of couples with impaired fertility, 40% achieved pregnancy after twelve months, with no therapy other than FFI combined with vitamin B6 and guafenesin, a simple medication to enhance cervical secretions.[25]
When a thorough diagnostic workup is done, and simple medical therapies such as low dose clomiphene and natural hormonal therapies such as natural progesterone and HCG are offered to enhance ovulation and hormone production in cooperation with the natural cycle, the results are excellent. Medications of the type used in Naprotechnology cost from $15-$70 per cycle, in contrast to the medication costs of thousands of dollars per cycle in ART. The risk of multiple births is minimized, because the goal of medical therapy in Naprotechnology is to reproduce the hormonal profile of an ideal natural cycle, rather than to produce the maximum number of eggs.
At the Pope Paul VI Institute, pregnancy is achieved in 80% of women whose main problem causing infertility is the absence of cycles. Diagnostic and therapeutic surgery is done for common conditions such as endometriosis and polycystic ovarian syndrome that is unresponsive to medications. At the Institute, the overall pregnancy rate for these conditions is 62.5-75% after two years.[26] Other centers have confirmed that very good results with traditional medical and surgical therapy can be achieved. A study of endometriosis patients undergoing laparoscopic surgery at a major center showed a pregnancy rate of 69.1 %. [27] Another recent prospective, randomized study at the University of Illinois showed that clinical pregnancy rates were higher for conventional medical therapy of infertility (as first-line therapy) than for ART (56% vs. 34.8%)[28] It is possible that the results achieved at these other centers might have been even higher if the patients were trained in self-monitoring for fertility.
The costs of Naprotechnology compare very favorably to ART, with brief medical evaluation and patient training to chart biomarkers and FFI costing $500 or less (not including laboratory studies or ultrasound). Medical therapies for infertility, laboratory and ultrasound diagnostic studies, and instruction in charting and FFI, cost $2500-5000 for three to six cycles of treatment. Surgical diagnosis and therapy, added to the aforementioned diagnostic studies, medical therapies, and NFP charting program, combine to make $10,000-15,000 the cost of comprehensive fertility treatment. Furthermore, the surgical therapies often produce long lasting results so that more than one pregnancy can be achieved. After the initial diagnostic and evaluation phase and treatment, the incremental cost for further cycles or pregnancies is quite low.
In a Catholic hospital setting, high-quality infertility services would be provided by a reproductive healthcare team. Core members of the team would be the physicians directing fertility therapy and natural family planning teachers. Other members of the team would be mental health professionals, ethicists, nutritionists, ultrasound technicians, social workers, financial counselors, pharmacists, medical laboratory technicians, and other physicians more peripherally involved with the infertility program. It is essential that the core members of the team be enthusiastic supporters and users of natural family planning in both their personal and professional lives, be thoroughly familiar with the moral and spiritual foundations of the Catholic view of reproductive healthcare, such as Humanae Vitae, and be inspired by the view that their work could have a transformative effect on their patients as well as on their community. Efforts should be made to recruit, educate, and convert other members of the team to views that are supportive of a culture of life. In most instances this will involve Catholics energized by this vision, but other people of faith may also fully embrace it.
The core physicians involved with the program should be fully familiar with the history and practice of the different types of NFP, and the applications of NFP to the treatment of infertility. These physicians should be thoroughly familiar with the biomarkers of infertility and fertility and contemporary research correlating NFP observations with measurement of hormones, ultrasound, and pregnancy outcomes. The only comprehensive training in medical applications of NFP for physicians that exists in the United States is the medical consultant program at the Pope Paul VI Institute. Since the Institute's training program gives participants a thorough historical, ethical and spiritual grounding, as well as exposing them to cutting edge research, it would be ideal for the core physicians to complete this program. The core physicians should be familiar with cost-effective medical protocols for ovulation induction, and fertility enhancement as well as lifestyle and nutritional modes of enhancing fertility. They should also be familiar with the diagnosis and treatment of male infertility. Coordination of services in such diverse areas as existing NFP departments in the hospital or community; consultants in ethics; surgical therapies for infertility; ultrasound and other radiological studies; laboratory medicine; pharmaceutical, psychological and social services is an essential part of the role for the core physicians.
The core physicians would ideally be generalist obstetrician gynecologists with a special interest in infertility and natural family planning, or obstetrician-gynecologists who are graduates of reproductive endocrine programs. Although there is a strong likelihood that the training and past medical practice of obstetrician-gynecologists included contraception and sterilization, and in the case of RE graduates, ART, it is essential that on assuming leadership in the development of Catholic infertility services, these practices be stopped. Moreover, the prevalent attitudes assimilated in current U.S. ob/gyn training programs must be unlearned. Some family practice physicians have also emerged as leaders in Naprotechnology for infertility and gynecologic problems.[29] Family practice training offers the advantage of a more holistic view of the person and family, and the possibility of avoiding contraception, sterilization, and ART in medical training and medical practice. The disadvantage for family practice physicians as leaders of an infertility program is the lack of training in surgical therapies for female infertility. In the U.S., the community of local physicians is more likely to support and refer to an obstetrician-gynecologist and possibly an RE graduate in the role as a fertility specialist. There is an emerging support network of NFP-only physicians that could be of help to physician candidates.
Natural family planning teachers are the other core members of the infertility team. They often have more intimate contact with the couple and might have insight into problems of which the physician is unaware. They can provide support for change away from destructive life-styles, including addictions, and unhealthy eating habits and sexual practices. The emotional support of the NFP teacher can also be very important for the couple undergoing fertility diagnosis and therapy, especially as the time frame for fertility treatments using natural cycles, and medical and surgical therapies is more on the order of twelve to eighteen months rather than the three months of ART. NFP teachers can be essential in helping the patient make ethical decisions, such as considering adoption, if infertility treatments are not successful.
Although all current contemporary methods of natural family planning, including both ovulation and symptothermal methods, have excellent results for helping couples avoid pregnancies; there are two advantages to the Creighton method of NFP for the purposes of achieving pregnancy. Cervical secretions in this method are assessed in a quantitative, reproducible, and objective way, which is useful in the diagnosis and monitoring of therapy for infertility. There is also original research utilizing this method, over the past two decades on tens of thousands of cycles, in which cervical secretions, cycle length, length of post-peak or luteal phase, and comprehensive hormonal and ultrasound evaluation are correlated with reproductive disorders, pregnancy rates and pregnancy outcomes. If a Catholic Hospital were teaching another method of NFP, modifying charting to conform to Creighton charting for those couples undergoing fertility diagnosis and therapy would be helpful.
Infertility services in a Catholic hospital should include cost-effective male and female sterilization reversal, and superior surgical therapy for female infertility. Thorough surgical treatment of endometriosis, the sequelae of pelvic inflammatory disease, pelvic adhesions, and conservative therapy for uterine fibroids, produce superior results to ART in many instances. This needs to be publicized and patients made aware of the relevant studies on outcomes. As techniques in gynecologic surgery are undergoing a change from open surgery to endoscopic surgery, it is desirable for surgeons on the team to develop skills in this area. An unfortunate consequence of the emphasis on ART in subspecialty training programs in reproductive endocrinology and infertility (RE) is that a true therapeutic void exists in the surgical therapy of infertility, where there is an absolute shortage of physicians interested in and trained in these areas. For the best outcomes, it might be desirable to have Catholic fertility centers develop collaborative relationships with the relatively small number of outstanding surgeons with skills in these areas.
The development of other areas is important. High quality and cost-effective ultrasound services are an integral part of an infertility program. New and exciting ultrasound research, much of it done at Pope Paul VI Institute, reveals that a large proportion of "unexplained" infertility is due to abnormalities in follicular maturation;[30] Catholic hospitals should be at the forefront of diagnosis and treatment in this area. The availability of ultrasound technicians on call to do scans for follicular maturation seven days a week will enhance the success rates of a fertility program. Urologists skilled in male sterilization reversal and male infertility should be part of the program. Ethicists should be available for consultation to help couples understand the serious issues involved in choosing fertility treatments. Psychotherapists skilled in marital therapy, in a Catholic approach to sexual dysfunction, and interested in the challenge that infertility poses to the couple, should be important members of the team. The availability of social workers conversant with how to proceed with domestic and foreign adoption is very important and appropriate for the couples who do not achieve a pregnancy. Nutritionists with a special interest in fertility, helping female patients with obesity, and an intelligent approach to nutritional supplements, would attract patients, as would pharmaceutical services that compound or stock the best preparations of natural hormones for fertility therapy.
As high-quality infertility services are developed in different departments of the hospital, there would be additional benefits. Therapies developed for infertility can be utilized for other medical problems. Excellence in reproductive ultrasound and surgery will improve other areas. As pregnancies occur from successful fertility therapies, the obstetrical services of the hospital will benefit. The natural hormones in the hospital pharmacy for fertility therapies, not available in the vast majority of chain pharmacies, are also some of the best therapies for PMS and postmenopausal hormone replacement. Effective weight loss programs and nutritionists conversant with nutritional therapies for medical and gynecological problems will definitely attract knowledgeable consumers by advertising or word of mouth. Psychotherapy services consistent with Catholic principles will draw people of faith and those with a traditional view of marriage. The NFP teachers who help couples become pregnant successfully will attract other couples wishing to avoid pregnancy.
There are other means of developing NFP-based services for infertility on a regional or national level. In some locales, trends in the contemporary culture and medicine have gone too far in taking over the local Catholic hospitals Interest or support among chief hospital administrators· may not exist because of opposition from physicians on the staff or lack of vision. In some locations, there is no Catholic hospital. In these situations, Naprotechnology has already been successfully utilized in individual physician office settings. Beyond the private office setting, just as single-specialty physician groups, physician networks, and networks of psychotherapists sometimes contract with insurance companies to provide services, so too a physician network, including NFP teachers, which provided cost-effective infertility diagnosis and therapy (excluding ART), could be an attractive option for insurance companies and consumers if properly developed and marketed. Pope Paul VI Institute, having been instrumental in developing the vision, could help in its implementation, by providing training, laboratory measurement of hormones, and research and treatment protocols.
In the future, Catholic university hospital obstetrics and gynecology departments have the potential to be important venues for the development of physician expertise and research of infertility therapies compatible with natural cycles and procreation. Unfortunately most Catholic university departments in this specialty do not have enough faculty members who are practitioners or philosophical acceptors of NFP, and even they may be unaware of applications of NFP research to fertility therapies. It should be a goal to eventually have at least one and as many as possible Catholic university obstetric and gynecology faculties in the future become acceptors and users of NFP for infertility applications, through the recruiting of new faculty, education and conversion of current faculty, and attrition and retirement of old faculty members not supportive of the vision and possibility of truly excellent Catholic care in this area. Philanthropic donation, in the form of research grants, could have a powerful effect in changing the orientation of a university department and might offset the effect of drug company support. For the immediate future, however, Catholic hospitals provide the best setting to bring together the resources necessary for the development of a successful Catholic infertility program, giving couples a welcome and viable alternative to ART. By benefiting these couples, their potential children, and their community, a successful Catholic infertility program could be a powerful source of a culture of life.
End Notes1. "Newly Catholic Hospital Bans Family Planning". Maria Alicia Gaura. San Francisco Chronicle. October l. 1999.
2. Belsey MA,, Ware H 1986 Epidemiological. social and psychological aspects of infertility in "Insler.V, Lunenfeld B (eds.) Infertility: male and female. 1st edn. Churchill Livingstone. Edinburgh. pp 631-647.
3.Insler , V. Lunenfeld.B 1995 Infertility. Male and Female. 2nd edn. Churchill Livingstone. Edinburgh. Fig 1.1,p 4.
4. Ibid ., Fig. 1.4, P 5.
5. Insler V. Lunenfeld B. Op. cit ., p 5.
6. Carlsen.E, Giwercman A. Keiding N. Skakkebaek NE 1992 "Evidence for decreasing quality of semen during the past 50 years" BMJ, Vol 305 (6854). pp 609-613.
7. "Fertility, Family Planning. and Women's Health: New Data from the 1995 Survey of Family Growth," May, 1997. CDC. National Department for Health Statistics. U.S. Department of Health and Human Services (DHHS). p 7.
8. PhytoPharmica, "Pioneering natural medicines for the health care professional", 1998, Green Bay, WI.
9. Hilgers, TW 1995 The Scientific Foundations of the Ovulation Method, Pope Paul VI Press, Omaha.
10. Ballweg, ML 1995 The Endometriosis Sourcebook .Contemporary Books, Chicago, pp 61-100.
11. Buster. J and Carson. 1998 "Taking a results-oriented approach 10 infertility" Contemporary Ob/Gyn. Vol. 43. No. 10. pp 100-126.
12. IVF: sperm and eggs are incubated together in a petri dish for fertilization; GIFr: gamete intra-fallopian transfer. where the ova are removed from the woman surgically and placed back in her fallopian tube with her husband's sperm; ZIFf: zygote intra-fallopian transfer. where the ova and sperm are incubated in the laboratory, and the resultant embryo placed in the woman's fallopian tube
13. Advanced Fertility Center of Chicago. 1998.
14. ICSI: the injection of the sperm into the ovum under the microscope by an embryologist
15. Advanced Fertility Center of Chicago. 1998
16. National Summary and Fertility Clinic Reports: Assisted Reproductive Technology Success Rates, December. 1997, DHHS.
17. CryoGam of Colorado. 1999.
18. Astarte Fertility Center of San Francisco, 1999.
19. National Summary and Fertility Clinic Reports: Assisted Reproductive Technology Success Rates. December 1997, DHHS.
20. Ibid.
21. Advanced Fertility Center of Chicago. 1998 : Standard IVF package $4900 including physician, laboratory and anesthesia costs; medication $1200-$5000; ICSI $1200, embryo storage $360/year. Sperm freezing $150, coculture $200. Donated semen and eggs add $200 - $8000.
22. Op. Cit., National Summary and Fertility Clinics Reports.
23. Hilgers, TW 1997 "Naprotechnology: The Contemporary Approach to Women's Health Care", Omaha, Pope Paul VI Institute.
24. Hilgers. TW Daly KD, Prebil AM et al. 1992 "Cumulative Pregnancy rates in Patients with Apparently Normal Ferility and Fertility-Focused Intercourse" , JRM Vol. 10, pp 864-866.
25. Hilgers, TW 1991 The Medical Applications of Natural Family Planning: A Contemporary Approach to Women's Health Care, Omaha, Pope Paul VI Institute.
26. Hilgers. TW. Pope Paul VI Institute.
27. Nezhat, C, Crowley S. Nezhat F 1989 "Videolaserlaparoscopy for the treatment of endometriosis associated with infertility," Fertil Steril Vo151. p 237. This study involved surgical therapy alone without self-monitoring for fertility.
28. Karande V. Korn. A et, al. 1999 "Prospective randomized trial comparing the outcome and cost of in vitro fertilization with that of a traditional treatment algorithm as a first-line therapy for couples with infertility," Fertil Steril Vol 71, P 468. This study involved medical therapy alone with out self-monitoring for fertility.
29. Boyle. P 1999 "Naprotechnology in Ireland", Annual Conference of the American Academy of Natural Family Planning, Lowell, MA
30. Hilgers, TW "Follicular Maturation Defects" 1999 American Institute of Ultrasound in Medicine Conference, San Antonio.
