Acupuncture Points used in IVF Clinical Trials
Tim H. Tanaka, Ph.D.
April 20, 2013
Note: Acupuncture protocols used in clinical studies are generally simplified, short, and standardized procedures, because the protocols are developed not only with consideration of its potential efficacy but also by considering its experimental design, budgets, time constraint, and other methodological factors.
They are compromised acupuncture protocols, and often far from those commonly used in clinical practice.
Study by Paulus, WE et al.
One hundred sixty patients who were undergoing IVF and who had good quality embryos were randomly divided into the following two groups: embryo transfer with acupuncture (n = 80) and embryo transfer without acupuncture (n = 80).
Each patient in the experimental group received an acupuncture treatment 25 minutes before and after embryo transfer.
The needles were left in position for 25 minutes and then removed.
Before embryo transfer, the following Acupoints were used:
PC6 (Neiguan), SP8 (Diji), LR3 (Taichong), GV20 (Baihui), and ST29 (Guilai).
After embryo transfer, the following Acupoints were used:
ST36 (Zusanli), SP6 (Sanyinjiao), SP10 (Xuehai), and LI4 (Hegu).
Additional AcuPoints:
Additional AcuPoints:
Auricular acupuncture at the following points, without rotation: ear point 55 (Shenmen), ear point 58 (Zhigong), ear point 22 (Neifenmi), and ear point 34 (Naodian). Two needles were inserted in the right ear, the other two needles in the left ear. The four needles remained in the ears for 25 minutes. The side of the auricular acupuncture was changed after embryo transfer.
The locations of acupuncture points used in this study are shown in Figures 1 and 2.
Figure 1: German Acupuncture Protocol Points before Embryo Transfer
Paulus WE, et al. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertility and sterility 2002; 77(4): 721-4.
Figure 2: German Acupuncture Protocol Points after Embryo Transfer
Paulus WE, et al. Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertility and sterility 2002; 77(4): 721-4.
Their results showed that clinical pregnancies were documented in 34 out of 80 patients (42.5%) in the acupuncture group, whereas pregnancy rate was only 26.3% (21 out of 80 patients) in the control group.
Since this preliminary study, a number of studies e.g. 2-7 have attempted to replicate their findings using the same or similar acupuncture around embryo transfer protocols (German Acupuncture Protocol), however, the results were equivocal.
A systematic review published in 2008,8 reported a non-significant impact of German acupuncture protocol, based on the meta-analysis of 8 trials on acupuncture during IVF. An updated meta-analysis of 9 trials by the same research group further confirmed their original finding.9 (about Systematic Review and Meta-Analysis)
Despite the less than impressive follow-up data since the highly publicized initial study by Paulus, et al.,1 the German protocol has been widely used among acupuncturists. In fact, it quickly became a “gold standard” acupuncture protocol during IVF cycle.
In my view however, the German acupuncture protocol is a typical example of the standardized, compromised acupuncture used in many acupuncture trials, which does not reflect the practice of classical acupuncture and traditional Chinese medicine.
Researchers studied more than 1,300 women
Acupuncture may increase the success rates of fertility treatment, according to a study.
The Dutch and US research, published in the British Medical Journal, found for every 10 IVF cycles with acupuncture, there would be one extra pregnancy.
However, the study, which looked at more than 1,300 women, hinted that patients at European clinics might not benefit as strongly.
A UK alternative medicine expert said he was not convinced by the results.
On the face of it, these results sound fantastic. I would, however, be very cautious
Dr Professor Edzard ErnstPeninsula Medical School
Approximately 10% to 15% of British couples have difficulty conceiving at some point in their lives and look for specialist fertility treatment.
IVF involves fertilising the egg with sperm outside the woman's body then putting the resulting embryo back into the womb.
Some couples face repeated expensive attempts to achieve a pregnancy.
Acupuncture has been used for centuries in China to regulate female fertility, and in recent years, scientists have been looking at whether it could boost IVF chances.
Studies have been mixed, with some showing benefits, and some even showing a reduced chance of conceiving.
The latest research, from the VU University in Amsterdam and the University of Maryland School of Medicine, combined the results of seven trials involving 1,366 women in an attempt to provide a clearer picture of the benefits.
They found that, looking at all the research together, women who underwent acupuncture were 65% more likely to have a successful embryo transfer compared with those who underwent a "sham" version of the treatment, or no extra treatment at all.
In real terms, this would mean that for every 10 women receiving acupuncture, there would be one extra successful embryo transfer.
European doubt
However, many of the studies were conducted in Chinese clinics which had a lower pregnancy rate than the average European clinic.
When only the three studies reaching this average - success in 28% of IVF cycles - were included, a different picture emerged.
Here, there was no evidence of any extra benefit from acupuncture, suggesting that offering the treatment in Europe might not offer as great, or any, increases in success rates.
In addition, a leading researcher into alternative treatments, Professor Edzard Ernst, from the Peninsula Medical School in Plymouth said he was dubious about the reliability of the acupuncture trials
He said: "On the face of it, these results sound fantastic. I would, however, be very cautious as much of the observed effect could be due to a placebo response.
"IVF may not seem to be "placebo-prone" but it probably is: if women expect it to be helpful they are more relaxed which, in turn, would affect pregnancy rates."
SOURCE: bbc.co.uk`
Objective:The aim of the present study was to evaluate the influence of acupuncture on pregnancy rate in assisted reproduction therapy (ART) by comparing two groups with/without acupuncture treatment shortly before and after embryo transfer.
Design:Prospective randomized study.
Materials/Methods:138 patients undergoing ART (ICSI, IVF) in our fertility centre were included in this study. Only patients with good embryo quality were admitted. They were divided into two groups by random numbers. Acupuncture was performed in 69 patients 25 minutes before and after embryo transfer. Before embryo transfer we used the following locations: Cx 6 (Neiguan), Sp8 (Diji), Liv3 (Taichong), Gv20 (Baihui), S29 (Guilai). After embryo transfer the sterile disposable stainless steel needles (0.25 × 25 mm) were inserted at the following points: S36 (Zusanli), Sp6 (Sanyinjiao), Sp10 (Xuehai), Li4 (Hegu). After 10 min the needles were rotated in order to maintain Deqi sensation. Additionally we used small stainless needles (0.2 × 13 mm) for auricular acupuncture at the following points without rotation: ear point 55 (shenmen), ear point 58 (zhigong), ear point 22 (Neifenmi), ear point 34 (Naodian). In the control group (n = 69) embryos were transferred without any supportive therapy. Covariate variables like age, number of previous cycles, number of transferred embryos, endometrial thickness, plasma estradiol, method of treatment, blood flow impedance in the uterine arteries or clinical indications for ART didn’t differ between both groups. The main outcome measure was clinical pregnancy defined by the presence of a fetal sac at ultrasound examination 6 weeks after embryo transfer. The Chi-square test was used for comparison of both groups.
Results: Clinical pregnancies were documented in 30 of 69 patients (43.5%) after embryo transfer supported by acupuncture, whereas the pregnancy rate only reached 26.1% (18 out of 69 patients) after embryo transfer without acupuncture (Chi-square test: P = 0.03).
Conclusions: Acupuncture seems to be a powerful tool to improve pregnancy rate in assisted reproduction therapy (ART).
SOURCE: thefertilesoulcefp.org/fertility-research/acupuncture-increace-pregnancy-rates-with-ART/
techniques to assist them in the reproductive process. The most common assisted reproduction therapy is in vitro fertilization (IVF), in which a woman's eggs are harvested and fertilized with a man's sperm in a laboratory.
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Embryos grown from the sperm and eggs are then chose to be transferred into the woman's uterus. In cases where a male's sperm count is extremely low, a different procedure known as intracytoplasmic sperm injection (ICSI) may be used.
Although assisted reproduction techniques like IVF and ICSI have been in use since the 1970s, they are still something of an inexact science. Success rates for each therapy range from as low as 1% to as high as 50%, and a successful pregnancy depends on a variety of factors, including the age of the woman, the cause of infertility, and the skill of the technician performing the procedure.
Two teams of researchers in Germany and the People's Republic of China have found that adding acupuncture to the treatment regimen of women using assisted reproductive techniques to have a child can dramatically improve the woman's chances of getting pregnant. Their findings, published in the April issue of Fertility and Sterility1 and widely reported in the popular press, could bring new hope to thousands of couples who would like to have children but have been unable to do so.
A total of 160 women undergoing either IVF or ICSI were chosen for the study and randomly assigned to a control group or an acupuncture group. The average age of the patient and the cause of infertility were approximately the same for each group; only patients with good quality embryos were included in the study.
After sperm and eggs were acquired, a maximum of three embryos were transferred into each woman's uterus using established transfer procedures, with the same procedure used for every patient in both groups. The examiner who performed the embryo transfers was not told which group each patient belonged to.
Patients in both groups received hormone therapy before and after embryo transfer to increase the odds of a successful pregnancy. Patients in the acupuncture group also received two acupuncture sessions - the first treatment 25 minutes before embryo transfer, the second treatment 25 minutes after. Needles (stainless steel, 0.25 x 25 millimeters) were inserted at various point locations, with the de qi sensation obtained during the initial insertion. After 10 minutes, the needles were rotated to maintain de qi. The needles were left in position for a total of 25 minutes per treatment session, then removed. Needle depth varied from 10-20 millimeters depending on the region of the body being needled.
In addition to body points, the scientists used smaller needles (0.2 x 13 mm) for auricular acupuncture at ear points 55 (shen men), 58 (zhi gong), 22 (nei fen mi) and 34 (nao dian). Two needles were inserted in the right ear, the other two in the left ear, for a total of four needles. The needles remained in place for 25 minutes without being manipulated; after embryo transfer, the side of auricular acupuncture was changed.
Six weeks after the embryo transfers were performed, all of the women were given an ultrasound examination. In the control group, the presence of a fetal sac, the scientists' criteria for a clinical pregnancy, was found in 21 women (26.3%). In the acupuncture group, the pregnancy rate was "considerably higher" - 34 women (42.5%) were carrying a fetal sac at the time of examination.
"Acupuncture seems to be a useful tool" for patients looking to increase their chances of becoming pregnant following assisted reproduction therapy, the authors concluded. They added, "As we could not observe any significant differences in covariants between the acupuncture and control groups, the results demonstrate that acupuncture improves pregnancy rate."
The researchers believe point selection played a key role in acupuncture's success. "We chose acupuncture points that relax the uterus according to the principles of TCM," they wrote, adding that because of acupuncture's influence on the autonomic nervous system, needling specific points would "optimize endometrial receptivity."
A total of nine points were used on patients in the acupuncture group. Before embryo transfer, PC6 (nei guan), SP8 (di ji), LR3 (tai chong), GV20 (bai hui) and ST29 (gui lai) were used; after transfer, needles were inserted at ST36 (zu san li), SP6 (san yin jiao), SP10 (xue hai) and LI4 (he gu).
Points on the spleen, stomach and colon meridians were chosen because of their ability to provide "better blood perfusion and more energy in the uterus"; PC6, LI20, GV20, and ear points 34 and 55 were used to sedate the patient; ear point 58 was used to "influence the uterus"; and ear point 22 was stimulated to stabilize the endocrine system.
As the main objective of the study was simply to determine whether acupuncture could increases pregnancy rate, the researchers stated that further research must be conducted "to demonstrate precisely how acupuncture causes physiologic changes in the uterus and the reproductive system." One future trial being considered will use a placebo needle to rule out any psychological or psychosomatic effects acupuncture may produce.
Scientific Community Embraces Results
Pregnancy and the birth of one's child are among the most exciting events an adult can experience. Unfortunately, for many people, attempting to have children can be a frustrating, expensive process, which more often results in failure than success.
"If these findings are confirmed, they may help us improve the odds for our IVF patients' achieving pregnancy," commented Dr. Sandra Carson, president-elect of the American Society of Reproductive Medicine, in a prepared statement.2 Fertility and Sterility is one of several journals published by the Society.
Equally impressed with the study's outcome was Dr. Nancy Synderman, a board-certified surgeon/pediatrician and medical correspondent for the popular news/talk shows Good Morning America and 20/20. In an interview with ABCNews.com, Snyderman explained that a woman's uterus typically undergoes several contractions while an embryo is being transferred, which reduces the chances of successful implantation significantly.
For years, health care professionals have theorized that relaxing the uterus during embryo transfer could increase a woman's chances of becoming pregnant, but the proof of this theory has been lacking. The Fertility and Sterility study, Snyderman feels, may have provided just the evidence the scientific community has been looking for.
"There is no doubt, because this was a very well-done study and it was reported in a very highly regarded medical journal, that doctors will sit up and pay attention to it," added Dr. Synderman. "This is the first time we may have had a serious marriage between an art and science that is so many, many years old, and what is really cutting-edge technology."3
SOURCE: acupuncturetoday.com
Medical experts are finding potential in the use of acupuncture as adjunctive therapy for women undergoing infertility treatment. In a new study testing the feasibility of this alternative approach, doctors compared outcomes between two groups of patients: those who underwent acupuncture combined with IVF, and those who underwent IVF alone.(1)A Medical Approach with a Long HistoryAcupuncture is one of the most ancient medical treatments in the world, dating back several millennia, originating in China, but finally becoming popular in more modern times in the United States in the early 1970s. The practice is used not just as an adjunctive infertility treatment, but also a wide variety of medical conditions.It involves applying a range of procedures that stimulate anatomical points on the body. The technique that has been studied the most scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation.Traditional Chinese medicine holds that there are more than 2,000 acupuncture points on the body, and that these connect with more than a dozen main and secondary pathways known as meridians. Chinese medicine practitioners believe these meridians conduct energy, or qi (chee), throughout the body. Essentially, acupuncture helps maintain the balance between qi and the opposing forces of yin and yang, which in turn regulates spiritual, emotional, mental and physical balance.(2)"Western medicine takes a very different approach," explained lead study investigator Paul Magarelli, MD, PhD, a practicing reproductive endocrinologist and medical director of the Reproductive Medicine & Fertility Center in Colorado Springs. "We use medications. We override [biological] systems."Yet while treatment for infertility, such as in-vitro fertilization (IVF), has taken major strides in the last two decades, odds are that couples won't achieve a pregnancy 60% of the time by solely using the Western approach, Magarelli explained. "A lot of the time, the patient gets one try at becoming pregnant, mainly because of the cost," he said.Considering the AlternativeThus, patients have begun looking at alternative options, mainly integrative medicine, in hopes of boosting those odds, Magarelli said.That was one motivation for this study. But Magarelli says he didn't always believe in the potential of complementary approaches like acupuncture. "I just did not feel that the data existed that supported acupuncture," he recalled. Over time, studying the medical literature about the topic intrigued him enough to launch a study of his own.In a previous analysis, Magarelli recruited patients with the poorest prognoses (over age 35, several male factor, elevated FSH level, or those who failed IVF in the past) in his clinic, who were given acupuncture in combination with IVF, and compared them with the same types of patients who received IVF alone. Two years later, he and his colleagues retrospectively evaluated the data."Those patients who were treated with the acupuncture [and] who were poor prognosis had equivalent pregnancies to those [considered] good prognosis patients," Magarelli explained, an outcome he found "amazing".This led to the latest study involving "good prognosis" patients. Specifically, the researchers wanted to determine the efficacy of electro stimulation or traditional acupuncture combined with auricular (or ear) acupuncture. Electro stimulation acupuncture is the term used to describe the approach that involves electrical stimulation. These approaches are used to either improve uterine bloodflow or help relax the uterus prior to embryo transfer in IVF.One hundred fourteen patients undergoing in-vitro fertilization after controlled ovarian hyperstimulation were included in the study. Only those women described as having a good response to ovarian hyperstimulation and whose partners' sperm morphology (quality) was also good were analyzed for the research.Each patient underwent ovarian hyperstimulation using a standard protocol, including the use of gonadotropins and a gonadotropin releasing-hormone (GnRH) agonist or antagonist. Each woman who then responded well to ovulation induction underwent either electro stimulation acupuncture or traditional combined with auricular acupuncture in conjunction with IVF. For this study, 53 underwent acupuncture combined with IVF, and 61 underwent IVF alone.The investigators then analyzed successful pregnancies in the group of women, as well as the miscarriage rate.Acupuncture Patients Had Improved OutcomesOf those in the acupuncture group, 51 percent achieved a successful pregnancy, the research team noted. That compares to 36 percent of those who underwent IVF alone. Comparatively, the miscarriage rate was 8% and 20% in the acupuncture versus non-acupuncture group, respectively.There were no ectopic (Tubal) pregnancies in the group of women who underwent acupuncture, but 9% of those in the group without acupuncture had a Tubal pregnancy. The investigators also reported 23% more births per pregnancy among those who had acupuncture as part of their infertility treatment."In previously published data, acupuncture was reserved for poorer prognosis patients, and enhanced outcomes were observed," wrote Magarelli and his colleagues. "In this study, we demonstrated that good prognosis patients would also benefit from inclusion of published acupuncture protocols."They say this is the first published study to include birth-related IVF outcome in patients also treated with acupuncture.Why does acupuncture theoretically work for infertility? Medical experts hypothesize that the ancient approach positively impacts opioid production in the central nervous system, which in turn, positively influences gonadotropin secretion.(3) These naturally-produced opioids, like endorphins, are similar to the actions of opiate drugs. Gonadotropins are the hormones that help promote normal reproductive function in the body. They include follicle-stimulating hormone (FSH), which helps promote follicle maturity prior to the release of an egg in women, and sperm production in men.(4) Experts also suggest acupuncture has a positive effect on uterine bloodflow.For the Future Medical experts are finding potential in the use of acupuncture as adjunctive therapy for women undergoing infertility treatment. In a new study testing the feasibility of this alternative approach, doctors compared outcomes between two groups of patients: those who underwent acupuncture combined with IVF, and those who underwent IVF alone.(1)A Medical Approach with a Long HistoryAcupuncture is one of the most ancient medical treatments in the world, dating back several millennia, originating in China, but finally becoming popular in more modern times in the United States in the early 1970s. The practice is used not just as an adjunctive infertility treatment, but also a wide variety of medical conditions.It involves applying a range of procedures that stimulate anatomical points on the body. The technique that has been studied the most scientifically involves penetrating the skin with thin, solid, metallic needles that are manipulated by the hands or by electrical stimulation.Traditional Chinese medicine holds that there are more than 2,000 acupuncture points on the body, and that these connect with more than a dozen main and secondary pathways known as meridians. Chinese medicine practitioners believe these meridians conduct energy, or qi (chee), throughout the body. Essentially, acupuncture helps maintain the balance between qi and the opposing forces of yin and yang, which in turn regulates spiritual, emotional, mental and physical balance.(2)"Western medicine takes a very different approach," explained lead study investigator Paul Magarelli, MD, PhD, a practicing reproductive endocrinologist and medical director of the Reproductive Medicine & Fertility Center in Colorado Springs. "We use medications. We override [biological] systems."Yet while treatment for infertility, such as in-vitro fertilization (IVF), has taken major strides in the last two decades, odds are that couples won't achieve a pregnancy 60% of the time by solely using the Western approach, Magarelli explained. "A lot of the time, the patient gets one try at becoming pregnant, mainly because of the cost," he said.Considering the AlternativeThus, patients have begun looking at alternative options, mainly integrative medicine, in hopes of boosting those odds, Magarelli said.That was one motivation for this study. But Magarelli says he didn't always believe in the potential of complementary approaches like acupuncture. "I just did not feel that the data existed that supported acupuncture," he recalled. Over time, studying the medical literature about the topic intrigued him enough to launch a study of his own.In a previous analysis, Magarelli recruited patients with the poorest prognoses (over age 35, several male factor, elevated FSH level, or those who failed IVF in the past) in his clinic, who were given acupuncture in combination with IVF, and compared them with the same types of patients who received IVF alone. Two years later, he and his colleagues retrospectively evaluated the data."Those patients who were treated with the acupuncture [and] who were poor prognosis had equivalent pregnancies to those [considered] good prognosis patients," Magarelli explained, an outcome he found "amazing".This led to the latest study involving "good prognosis" patients. Specifically, the researchers wanted to determine the efficacy of electro stimulation or traditional acupuncture combined with auricular (or ear) acupuncture. Electro stimulation acupuncture is the term used to describe the approach that involves electrical stimulation. These approaches are used to either improve uterine bloodflow or help relax the uterus prior to embryo transfer in IVF.One hundred fourteen patients undergoing in-vitro fertilization after controlled ovarian hyperstimulation were included in the study. Only those women described as having a good response to ovarian hyperstimulation and whose partners' sperm morphology (quality) was also good were analyzed for the research.Each patient underwent ovarian hyperstimulation using a standard protocol, including the use of gonadotropins and a gonadotropin releasing-hormone (GnRH) agonist or antagonist. Each woman who then responded well to ovulation induction underwent either electro stimulation acupuncture or traditional combined with auricular acupuncture in conjunction with IVF. For this study, 53 underwent acupuncture combined with IVF, and 61 underwent IVF alone.The investigators then analyzed successful pregnancies in the group of women, as well as the miscarriage rate.Acupuncture Patients Had Improved OutcomesOf those in the acupuncture group, 51 percent achieved a successful pregnancy, the research team noted. That compares to 36 percent of those who underwent IVF alone. Comparatively, the miscarriage rate was 8% and 20% in the acupuncture versus non-acupuncture group, respectively.There were no ectopic (Tubal) pregnancies in the group of women who underwent acupuncture, but 9% of those in the group without acupuncture had a Tubal pregnancy. The investigators also reported 23% more births per pregnancy among those who had acupuncture as part of their infertility treatment."In previously published data, acupuncture was reserved for poorer prognosis patients, and enhanced outcomes were observed," wrote Magarelli and his colleagues. "In this study, we demonstrated that good prognosis patients would also benefit from inclusion of published acupuncture protocols."They say this is the first published study to include birth-related IVF outcome in patients also treated with acupuncture.Why does acupuncture theoretically work for infertility? Medical experts hypothesize that the ancient approach positively impacts opioid production in the central nervous system, which in turn, positively influences gonadotropin secretion.(3) These naturally-produced opioids, like endorphins, are similar to the actions of opiate drugs. Gonadotropins are the hormones that help promote normal reproductive function in the body. They include follicle-stimulating hormone (FSH), which helps promote follicle maturity prior to the release of an egg in women, and sperm production in men.(4) Experts also suggest acupuncture has a positive effect on uterine bloodflow.For the FutureThe study will likely be expanded early next year, Magarelli study. In the next phase, data will be collected on all patients, regardless of prognosis. "I would suspect that ... we're going to see that, across the board, we can improve anywhere between 5 percent and 15 percent the number of babies successfully created through the process of IVF and acupuncture," he said."What blows me away, personally, is how I have absolutely seen things that I didn't think were possible by placing a needle somewhere."The study will likely be expanded early next year, Magarelli study. In the next phase, data will be collected on all patients, regardless of prognosis. "I would suspect that ... we're going to see that, across the board, we can improve anywhere between 5 percent and 15 percent the number of babies successfully created through the process of IVF and acupuncture," he said."What blows me away, personally, is how I have absolutely seen things that I didn't think were possible by placing a needle somewhere." SOURCE: eastwindsacupuncture.com
