Fertility Nurses First

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1 Fertility Nurses First The Evolution of Revolution: How Trditionl Chinese Medicine Brings IVF into Modern Times Author: Pul C. Mgrelli, MD, PhD, FACOG Couthor: Dine K. Cridennd, LAc, FABORM Chin s Culturl Revolution mrked move from the pst into new pln for the future. A smll pper published in 2002 in Fertility & Sterility by Pulus WE, et l. 1 showed similr, though reltively silent revolution. The reserch suggested tht dding cupuncture under strict protocol to ptients undergoing in vitro fertiliztion (IVF) demonstrted improvements in reproductive outcomes, i.e., more pregnncies. The impct of this smll study ws not fully relized for severl yers. However, its results prompted Dine K. Cridennd, LAc to chllenge Pul C. Mgrelli, MD, PhD to question how he could help his ptients by stretching for solutions outside the relm of llopthic medicine. Cridennd met with Mgrelli in 2002 to discuss her belief tht by dding Trditionl Chinese Medicine (TCM) in the form of cupuncture, more ptients could get nd sty pregnnt. Mgrelli s position ws tht ny medicl tretment must ethiclly hve scientific bsis before subjecting ptients to it. He sked her to provide dt to support her position. She returned with the pper by Pulus WE, et l. 1 nd dded new study by Stener- Victorin s group discussing fvorble physiologic chnge in blood flow [pulstility index (PI)] through the uterine rtery in IVF ptients treted with cupuncture. 2 Acupuncture Physiology Acupuncture is the plcement of fine needles into specific cupoints long the pthwys of energy in the body. Acupoints relieve blockges nd restore the flow of Qi, pronounced [CHEE] or energy, encourging the body s nturl bility to hel itself. When Qi is blnced nd orgns re nourished, the body will be ble to function t their cpcity nd, in this cse, for procretion. This process works by sending messges to the brin lmost like progrmming computer. Qi is conducted through protein molecules giving us energy nd life. Qi moves by wy of meridins web or network of chnnels, which sets up communiction between every orgn in the body. TCM prctitioners hve mpped these chnnels out over the course of thousnds of yers of experimenttion nd observtion. The insertion of fine needles into the cupoints long the meridins produces mesurble effects on different prts of the body. This is how cupuncture cn ffect bdominl orgns, such s the kidneys, liver nd uterus by plcing needles in the rms nd legs. There re specific cupuncture points which relte to fertility, but the single most importnt theory is this: When Qi flows through the body in the correct direction t the right time, the body will return to helth. issue 34

2 Acupuncture nd IVF: Reserch Protocols Over the next yer, IVF ptients with poor prognosis for success including hving previous IVF filures, being older thn 35 yers of ge, or hving severe mle fctor or poor ovrin reserve s mesured by dy 3 follicle stimulting hormone (FSH) levels, were told tht locl cupuncturist experienced some success in improving IVF outcomes nd could tret them with cupuncture if interested. Mny ptients decided to see Cridennd for cupuncture tretments nd some returned to Mgrelli s clinic for tretment for IVF only. Upon observtion, more ptients were getting pregnnt. In response to these results, Mgrelli, Cridennd nd Cohen decided to crete reserch protocols to prove or disprove the efficcy of cupuncture tretment in IVF ptients. The uthors hve published chpter in Western textbook on reproductive endocrinology nd infertility in which they ly out the foundtions of their reserch. Excerpts re below: 3 Bckground Assisted reproductive technologies (ART) provide reproductive services to infertile couples throughout the world in the form of IVF. The process of IVF begn with the Birth of Louise Brown in 1978 by Edwrds nd Steptoe. 4 The process hs evolved significntly over the yers. Like the first hert trnsplnt, IVF hs gone from medicl wonder to stndrd of cre. Tody over 1 million IVF cycles 5 re performed ech yer round the world for popultion of 6 billion men nd women. Most estimtes of infertility when clculted, represent 15 percent of mrried/bonded couples. This would predict mny more couples in need of reproductive cre who re not ble to crete the fmily they hve dremed of, probbly due to the expenses ssocited with the complexity of cre required. Prt of the problem of poor utiliztion of IVF is cost nd ccess to cre. Others include the depersonliztion of the process nd resistnce on the prt of the couples themselves. Fertility is personl mtter, which is publicly monitored. It is in the nture of community to require reproduction for survivl. The pek of humn fertility is t 25 yers of ge, llowing for 25 percent chnce to conceive ech month. For most couples, this hovers t 10 percent since they my not even strt thinking of hving children until fter eduction is complete, jobs re intct nd houses re purchsed. By this time, most couples re nering 30 yers of ge nd just beginning to consider hving bby. 6 After months of trying to conceive, issues of personl identity, frustrtion, guilt nd losing fith in their body sets in. Most couples lose sense of freedom s they no longer hve intercourse for the resons of love nd true intimcy. Intercourse now turns into job, timed t best. Couples begin to lose sight of the reson for hving child together s they experience sorrow nd frustrtion month fter month when the menses occurs, despite the vigorous ttempts to chieve pregnncy. Technology my be ble to help, but t price. Historicl Perspective In the United Sttes, IVF progrms strted in the 1980s, proliferted during the mid to lte 90s, nd hve grown to represent over 150,000 tretment cycles in the erly prt of the 21 st century. IVF progrms, ccording to the Centers for Disese Control nd Prevention, hve reported reproductive outcomes from 1986 to The verge improvement ech yer represents 1 percent to 2 percent gin per tretment in positive outcomes, pregnncy or bbies, from 1985 to After 2001, no improvement but only modest decrese in outcomes (34 percent to 33 percent) hs been seen. Although the current results re ludble, Cridennd sought to enhnce the rte of improvement by chllenging Western tretments for IVF. Mgrelli, Cridennd nd Cohen, encourged by the bove bckground nd historic perspective, developed study protocol, published s the Cridennd/Mgrelli TCM protocol. This lter served s the bsis for ll subsequent studies they reported. Key elements re shown in Tble 1. 2

3 Tble 1. Key Elements of the Cridennd/Mgrelli TCM Protocol Key elements Recruitment ws prospective. Resoning Elimintes historicl comprisons nd strengthens study pplicbility. Recruitment for cupuncture ws hidden or blinded to the physicin. Reduces physicin bis. IVF tretment protocols were hidden or blinded to the cupuncturist. Reduces cupuncturist bis. Only stndrdized cupuncture tretments were llowed (no differentition of syndromes s bsis of tretments were done). Elimintes tretment selection bis. All dt ws collected by third prty, Mel Cohen, PhD, nd kept from the physicin nd cupuncturist for three yers. Reduces investigtor bis. Contrcts were written nd signed by ll TCM prctitioners to follow the prescribed protocols for tretments. Elimintes tretment vribility. TCM prctitioners greed to provide coverge for ptients in the study 24/7. For exmple, embryo trnsfers occurred on weekends nd holidys nd ptients needed to ccess their cupuncturist. Reduces timing or convenience bis. Ptients, without coercion, selected whether or not to prticipte. Does NOT eliminte selection bis ( wekness of most TCM studies). No monetry gin ws provided to prticipte. Reduces selection bis for monetry gin. No reduction in IVF fees for prticiption in the study ws given. Reduces tretment bis bsed on monetry gin. No reduction in TCM tretment fees for prticiption in the study ws given. Reduces tretment bis bsed on monetry gin. Most study dt collected from 2002 were reviewed in Reduces impct of positive outcomes on ptient choice to perform cupuncture. Study of cortisol/prolctin Although not rndomized, the study ws blinded to the cupuncturists, physicins nd sttisticin until nlyzed. Mgrelli PC, Cridennd DK, Cohen M. Chnges in serum cortisol nd prolctin ssocited with cupuncture during controlled ovrin hyperstimultion in women undergoing in vitro fertiliztion-embryo trnsfer tretment. Fertil Steril. 2009;92(6):

4 The Cridennd/Mgrelli TCM protocol hs been used to nlyze more thn 800 IVF cycles since The protocol s dt set my be the lrgest in the world correlting specific TCM protocol s impct on IVF outcomes. Reserch using the protocol ws ctegorized by ptient type nd scientific principl in the studies shown in Tble 2: Tble 2. Ctegories Studied Using Cridennd/Mgrelli TCM Protocol 1 Poor prognosis 7 Elevted FSH Severe sperm fctor Advnced mternl ge Poor PI (i.e., uterine rtery blood flow) 2 Improved prognosis 8 Anything not listed in poor prognosis section bove 3 All IVF ptients 9 Regrdless of prognosis Outcomes Dt Reveled Per Ctegory 1. Poor Prognosis Ctegory (Figure 1) Improvements in reproductive outcomes were demonstrted when poor prognosis ptients received cupuncture tretments before, during nd fter their IVF tretments. A stndrdized cupuncture tretment protocol in lieu of tretments utilizing differentition of syndromes cn be used to improve reproductive outcomes (i.e., pregnncy nd live birth). Conclusion Poor prognosis predictions of outcomes could be corrected nd outcomes could be creted closer to nd in some cses to surpss improved prognosis ptient outcomes for pregnncy nd especilly live birth. 4 Number of cupuncture tretments 10 5 Embryology nd eggs 11 6 Demogrphics nd ptient infertility dignosis 12 7 Cortisol/ prolctin 13 Idel number of needed for fvorble outcome (i.e., pregnncy) Impct of TCM Effects regrding pregnncies, miscrriges, ectopics, multiples nd live births Impct of ptient infertility dignosis on effects of TCM Mechnism of ction responsible for impct of TCM tretment (i.e., chnges in stress hormones cortisol or prolctin) 2. Improved Prognosis Ctegory Pregnncy outcomes were equl between the cupuncture group nd the noncupuncture group, not unlike the Poor Prognosis ctegory. Birth outcomes were improved between the cupuncture group nd the noncupuncture group. Improved pregnncy outcomes for ll ptients Improved pregnncy outcomes for pregnnt ptients Significntly fewer spontneous bortionss Significntly fewer ectopic pregnncies Conclusion Even given the Good Prognosis ctegory, ptients treted with the Cridennd/Mgrelli TCM protocol benefited with improved outcomes. 4

5 Figure 1. Impct of Acupuncture on IVF Poor Responder Ptients Rtes 90% 80% 70% 60% 50% 40% p < 0.05 Std IVF Control PPr Control PPr Acupuncture Dt bsed on n = 147. Std = Stndrdized. PPr = Poor prognosis. IVF = In vitro fertiliztion. SAB = Spontneous bortion. 30% 20% p < % 0% Pregnncy 0% 0% SAB Ectopic Birth/Ongoing Pregnncy Used with permission from Pul C. Mgrelli, MD, PhD, FACOG. Figure 2. Impct of Acupuncture on IVF Ptients Rtes/ Trnsfer 90% 80% 70% 60% 50% 40% 30% 20% b Control Acupuncture Ptients = 203 FSH rnge = 2-20 Age rnge = Pulstility Index rnge = Bsl metbolic index rnge = IVF = In vitro fertiliztion. SAB = Spontneous bortion. Dt re bsed on over five yers of IVF monitored cycles. b p < % 0% Pregnncy SAB Ectopic Tke Home Bbies b b Multiple Bbies Used with permission from Pul C. Mgrelli, MD, PhD, FACOG. 5

6 3. All IVF Ptients Ctegory (Figure 2) Pregnncy outcomes were superior in the cupuncture group vs. noncupuncture group (p < 0.05). Significntly more pregnncies (p < 0.05) Birth outcomes were improved between the cupuncture group nd the noncupuncture group Improved pregnncy outcomes for pregnnt ptients Fewer miscrriges Significntly fewer ectopic pregnncies (p < 0.05) Significntly fewer multiple pregnncies (p < 0.05) Conclusion Acupuncture, even if given to ll-comers, will benefit the IVF prctice by improving reproductive outcomes. 4. number of Acupuncture Tretments Ctegory The Stener-Victorin protocol of eight cupuncture tretments underestimtes by one tretment the idel number needed for improvements in pregnncy rtes using the protocol. Acupuncture without regrd to PI ws believed to improve pregnncy outcome if nine or more electrostimultion tretments (where pirs of cupuncture needles re ttched to device tht genertes continuous electric pulses between them) re provided. Dizepm does not pper to lter the effects of the Pulus WE, et l. protocol on IVF outcomes bsed on uterine quiescence. Conclusion As in Western medicine, it is dose, durtion nd type of tretment tht contribute to efficcy. The Cridennd/ Mgrelli TCM protocol ws demonstrted to hve n idel number of tretments for improved outcomes. 5. Embryology nd Eggs Ctegory Acupuncture contributes to improved reproductive outcomes in the following wys: Improved pregnncy rtes Reduced miscrrige rtes Significntly reduced ectopic pregnncy rtes More tke-home bbies The mechnism for the effects of cupuncture is not bsed on objective embryology chrcteristics such s: Number of eggs: Retrieved Fertilized normlly Implnted Frozen Number of: Embryos trnsferred Dys of trnsfer Previous IVF cycles 6

7 Conclusion Chnges in eggs or embryo qulity were ruled out. Chnge ws ttributed to the host tht ws influenced by cupuncture. 6. demogrphics nd Ptient Infertility Dignosis Ctegory Acupuncture supports pregnncy outcomes for IVF ptients This study segregtes which IVF ptients would best benefit from cupuncture. They re those with: Advnced ges Polycystic ovrin syndrome Mle fctor Tubl fctor Conclusion Ptients with the highest opportunity for success with IVF, including those who re younger nd with good prognosis, my NOT be helped s much by cupuncture. 7. Cortisol/Prolctin Ctegory (Figures 3 nd 4) IVF tretments pper to crete nonphysiologic chnges in prolctin nd cortisol levels through the stimultion phse of the IVF cycle. Acupuncture ppers to reverse this nonphysiologic chnge nd return IVF ptient s hormone profiles to more physiologic/reproductive levels. One mechnism of ction of cupuncture on IVF outcomes my be the normliztion of cortisol nd prolctin during the stimultion phse of the IVF cycle. Conclusion The December 2009 study by Mgrelli, Cridennd nd Cohen 13 in Fertility & Sterility provides rod mp for revolution in the integrtion of Western nd Estern medicl prctices. The uthors were ble to reduce bis to minimum by utilizing serum levels of cortisol nd prolctin tht were collected in blinded fshion, over protrcted period of time. This ws done without knowledge of the types of fertility tretments, including cupuncture. The results demonstrted tht by using the Cridennd/Mgrelli cupuncture protocol, TCM reported tht more pregnncies could be explined by beneficil chnges in serum levels of cortisol nd prolctin, which mimicked norml pregnncy menstrul cycles. Figures 3 nd 4 on the following pge, show the chnges in serum levels of prolctin nd cortisol ssocited with cupuncture (solid dimonds) in women undergoing controlled ovrin hyperstimultion for IVF-embryo trnsfer. Acupuncture ws ssocited with significnt increse in prolctin levels (solid dimonds) on stimultion dys 4, 5, 6 nd 7. However, cortisol levels were significntly higher on stimultion dys 7, 8, 9, 11, 12 nd 13 in ssocition with the cupuncture treted group. 7

8 Figure 3. Prolctin Levels in Controlled Ovrin Hyperstimultion for IVF-ET Acupuncture Prolctin (Ng/mL) Control IVF = In vitro fertiliztion. ET = Embryo trnsfer. p < Stimultion Dy Used with permission from Pul C. Mgrelli, MD, PhD, FACOG. Figure 4. Cortisol Levels in Controlled Ovrin Hyperstimultion Acupuncture Control Cortisol (Ng/mL) p < Stimultion Dy Used with permission from Pul C. Mgrelli, MD, PhD, FACOG. 8

9 Evolution of Revolution IVF outcomes demonstrted by studies from Mgrelli, Cridennd nd Cohen re compred on severl reputble sites on the World Wide Web nd serve s resources for news reporting gencies nd regultory bodies. These studies strive for ptient sfety nd efficcy of ART. Over 3,000,000 bbies hve been born becuse of ART. Issues relted to multiple nd ectopic pregnncies, miscrriges nd costs for cre cn ffect ptient decisions to proceed with seeking out infertility tretment. Although Estern medicine hs proven successful for these IVF ptients for thousnds of yers, mny Western medicl professionls my struggle to understnd how it works. Mgrelli, Cridennd nd Cohen, s well s others, hve demonstrted tht cupuncture for IVF improves pregnncy outcomes when dded to IVF protocols. The Cridennd/Mgrelli TCM protocol ws designed from its inception to meet the null hypothesis of Acupuncture does NOT help. Tht null hypothesis ws proven incorrect, s ws explined by the cortisol nd prolctin dt. Mgrelli, Cridennd nd Cohen hope their primitive work stimultes universities nd the Ntionl Institutes of Helth to investigte the link nd confirm their dt. About the uthor: Pul C. Mgrelli, MD, PhD, FACOG is bord certified in reproductive endocrinology nd infertility (REI) in the stte of Colordo nd hs been in prctice since He is founder nd medicl director of Reproductive Medicine & Fertility Centers in both Colordo nd New Mexico nd is ntionlly recognized for his expertise in REI nd the development of costeffective plns for fertility cre. These plns include Plnning 4 Pregnncy nd High Tech with Personl Touch. Dr. Mgrelli is lso ppluded for his ground-breking reserch integrting Estern (Trditionl Chinese Medicine, including cupuncture) nd Western medicl tretments for infertility. He hs presented numerous lectures t orgniztions such s the Americn Assocition of Medicl Acupuncturists, Society for Acupuncture Reserch nd Americn Assocition of Acupuncture & Orientl Medicine. He hs lso published severl works on the subject including the first Estern medicine chpter in Western medicl textbook on reproductive medicine (Infertility nd Assisted Reproduction). Dr. Mgrelli is currently n dvisor to the Americn Bord of Orientl Reproductive Medicine nd is member of the Americn Society for Reproductive Medicine, Society of Assisted Reproductive Technologies nd Pcific Cost Fertility Society. 9

10 References 1. Pulus WE, Zhng M, Stehler E, El-Dnsouri I, Sterzik K. Influence of cupuncture on the pregnncy rte in ptients who undergo ssisted reproduction therpy. Fertil Steril. 2002;77(4): Stener-Victorin E, Wldenstrom U, Andersson SA, Wiklnd M. Reduction of blood flow impednce in the uterine rteries of infertile women with electrocupuncture. Hum Reprod. 1996;11(6): Mgrelli P, Cohen M, Cridennd, D. Acupuncture: impct on pregnncy outcomes in IVF ptients. Pper presented t the 12th World Congress on Humn Reproduction; Mrch 10-13, 2005; Venice, Itly. Cridennd D, Mgrelli P, Cohen M. Acupuncture nd in vitro fertiliztion: does the number of tretments impct reproductive outcomes? Pper presented t the Society for Acupuncture Reserch; October 22, 2005; Venice, Itly Mgrelli PC, Cridennd, DK, Cohen, M. Revolution in Assisted Reproductive Technologies: The Role of Trditionl Chinese Medicine on IVF outcomes. Infertility nd Assisted Reproduction. 1st ed. New York, NY: Cmbridge University Press; 2008: Steptoe PC, Edwrds RG. Birth fter the reimplnttion of humn embryo. Lncet 1978;2(8085):366. Horsey, K. 3,000,000 IVF Bbies Born Worldwide Since Pper presented t the nnul conference of the Europen Society of Humn Reproduction nd Embryology (ESHRE); June 18-21, 2006; Prgue, Czech Republic. Speroff, F. Clinicl Gynecologic Endocrinology nd Infertility. 7th ed. Lippincott Willims & Wilkins; 2005;4(4): Mgrelli P, Cridennd D. Acupuncture nd IVF poor responders: cure? Fertil Steril. 2004;81(4):S2. Mgrelli P, Cohen M, Cridennd D. Acupuncture nd good prognosis IVF ptients: synergy. Fertil Steril. 2004; 82(4):S80-S81. Mgrelli P, Cohen M, Cridennd, D. Improvement of IVF outcomes by cupuncture: re egg nd embryo qulities involved? Fertil Steril. 2005; 83(4):S Mgrelli P, Cridennd D, Cohen M. The demogrphics of cupuncture s impct on IVF outcomes: infertility dignosis nd SART/CDC/ge groups. Fertil Steril. 2007;V87(3):S10-S Mgrelli PC, Cridennd DK, Cohen M. Chnges in serum cortisol nd prolctin ssocited with cupuncture during controlled ovrin hyperstimultion in women undergoing in vitro fertiliztion-embryo trnsfer tretment. Fertil Steril. 2009;92(6): Resources Chng R, Chung PH, Rosenwks Z. Role of cupuncture in the tretment of femle infertility. Fertil Steril. 2002;78(6): Dickey RP, Holtkmp D. Development, phrmcology nd clinicl experience with Clomiphene citrte. Humn Reprod Updte. 1996;2(6): Dieterle S, Ying G, Htzmnn W, Neuer A. Effect of cupuncture on the outcome of in vitro fertiliztion nd intrcytoplsmic sperm injection: rndomized, prospective, controlled clinicl study. Fertil Steril. 2006;85(5): Ltov, N. Evidence bsed guidelines: not recommended. J Am Phys Surg. 2005;10(1):

11 Pulus WE, Zhng M, Stehler E, Seybold B, Sterzik K. Plcebo-controlled tril of cupuncture effects in ssisted reproduction therpy. Letter to the Editor. Fertil Steril. 2002;78(4):4. Quintero R. A rndomized, controlled, double-blind, cross-over study evluting cupuncture s n djunct to IVF. Fertil Steril. 2004;81(1):S11-S12. Smith C, Coyle M, Normn RJ. Influence of cupuncture stimultion on pregnncy rtes for women undergoing embryo trnsfer. Fertil Steril. 2006;85(5): Westergrd LG, Mo Q, Krogslund M, Sndrini S, Lenz S, Grinsted J. Acupuncture on the dy of embryo trnsfer significntly improves the reproductive outcome in infertile women: prospective, rndomized tril. Fertil Steril. 2006;85(5):

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