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FERTILITY AND STERILITY® VOL. 77, NO. 4, APRIL 2002
Copyright ©2002 American Society for Reproductive Medicine
Published by Elsevier Science Inc., Printed on acid-free paper in
U.S.A.
Influence of acupuncture on the
pregnancy rate in patients who
undergo assisted reproduction
therapy
Wolfgang E. Paulus, M.D.,[a] Mingmin Zhang, M.D.,[b] Erwin Strehler,
M.D.,[a) Imam El-Danasouri, Ph.D.,[a] and Karl Sterzik, M.D.[a]
Christian-Lauritzen-Institut, Ulm, Germany
Received June 5, 2001; revised and accepted October 16, 2001.
Reprint requests: Wolfgang E. Paulus, M.D., Christian-Lauritzen-
Institut, Frauenstr. 51, D-89073, Ulm, Germany (FAX: ++49-731-
9665130; E-mail: paulus@reprotox.de).
[a] Department of Reproductive Medicine, Christian-Lauritzen-Institut.
[b] Department of Traditional Chinese Medicine, Tongji Hospital,
Tongji Medical University, Wuhan, People's Republic of China.
0015-0282/02/$22.00
PII S0015-0282(01)03273-3
Objective: To evaluate the effect of acupuncture on the pregnancy
rate in assisted reproduction therapy (ART) by comparing a group of
patients receiving acupuncture treatment shortly before and after
embryo transfer with a control group receiving no acupuncture.
Design: Prospective randomized study.
Setting: Fertility center.
Patient(s): After giving informed consent, 160 patients who were
undergoing ART and who had good quality embryos were divided into
the following two groups through random selection: embryo transfer
with acupuncture (n = 80) and embryo transfer without acupuncture (n
= 80).
Intervention(s): Acupuncture was performed in 80 patients 25
minutes before and after embryo transfer. In the control group,
embryos were transferred without any supportive therapy.
Main Outcome Measure(s): Clinical pregnancy was defined as the
presence of a fetal sac during an ultrasound examination 6 weeks
after embryo transfer.
Result(s): Clinical pregnancies were documented in 34 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.
Conclusion(s): Acupuncture seems to be a useful tool for improving
pregnancy rate after ART. (Fertil Steril®2002;77:721- 4. ©2002 by
American Society for Reproductive Medicine.)
Key Words: Acupuncture, assisted reproduction, embryo transfer,
pregnancy rate
Materials and Methods
This study was a prospective randomized trial at the Christian-
Lauritzen-Institut in Ulm, Germany. It was approved by the ethics
committee of the University of Ulm. A total of 160 healthy women
undergoing treatment with in vitro fertilization (IVF; n = 101) or
intracytoplasmic sperm injection (ICSI; n = 59) were recruited into the
study. The age of the patients ranged from 21 to 43 (mean age: 32.5
= 4.0 years). The cause of infertility was the same for both groups
(Table 1). Only patients with good embryo quality were included in the
study. Using a computerized randomization method, patients were
assigned into either the acupuncture group or the control group.
Ovarian stimulation, oocyte retrieval, and in vitro culture were
performed as previously described (7). Transvaginal ultrasound-
guided needle aspiration of follicular fluid was performed 36 to 38
hours after hCG administration. Immediately after follicle puncture, the
oocytes were retrieved, assessed, and fertilized in vitro. Sperm
preparation and culture conditions did not differ for either group.
In cases of severe male subfertility, ICSI was preferred, as described
in the literature (8). Forty-eight hours after the IVF or ICSI procedure,
embryos were evaluated according to their appearance as type 1 or 2
(good), type 3 or 4 (poor), as described in literature (9).
(good), type 3 or 4 (poor), as described in literature (9).
Just before and after embryo transfer, all patients underwent
ultrasound scans of the uterus using a 7-MHz transvaginal probe
(LOGIQ 400 Pro, GE Medical Systems Ultra-sound Europe, Solingen,
Germany). Pulsed Doppler curves of both uterine arteries were
measured by one observer. The pulsatility index (PI) for each artery
was calculated electronically from a smooth curve fitted to the average
waveform over three cardiac cycles.
A maximum of three embryos, in accordance with German law, were
transferred into the uterine cavity on day 2 or 3 after oocyte retrieval.
For embryo replacement, the patient was placed in a dorsal lithotomy
position, with an empty bladder. The cervix was exposed with a
bivalved speculum, then washed with culture media prior to embryo
transfer. Labotect Embryo Transfer Catheter Set (Labotect GmbH,
Go¨ ttingen, Germany) was used for atraumatic replacement
owing to the curved guiding cannula with a ball end, allowing the set
to be used reliably even with difficult anatomic conditions. The metallic
reinforced inner catheter shaft al lowed safe passage through the
cervical canal. When the catheter tip lay close to the fundus, the
medium containing the embryos was expelled and the catheter
withdrawn gently. After this procedure, the patient was placed at bed
rest for 25 minutes. All oocyte retrievals and embryo transfers were
performed by one examiner using the same method. The examiner
was not aware of the patient's treatment group (control or
acupuncture).
At the time of the embryo transfer, blood samples (10 mL) were
obtained from the cubital vein. Plasma estrogen was determined by
an immunometric method using the IMMULITE 2000 Immunoassay
System (DPC Diagnostic Product Corporation, Los Angeles, CA).
Luteal phase support was given by transvaginal progesterone
administration (Utrogest®, 200 mg, three times per day; Kade, Berlin,
Germany). Progesterone administration was initiated on the day after
oocyte retrieval and was continued until the serum ß-hCG
measurement 14 to 16 days after transfer and, in cases of pregnancy,
until gestation week 8.
Each patient in the experimental group received an acupuncture
treatment 25 minutes before and after embryo transfer. Sterile
disposable stainless steel needles (0.25 X 25 mm) were inserted in
acupuncture point locations. Needle reaction (soreness, numbness, or
distention around the point = Deqi sensation) occurred during the
initial insertion. After 10 minutes, the needles were rotated in order to
maintain Deqi sensation. The needles were left in position for 25
minutes and then removed. The depth of needle insertion was about
10 to 20 mm, depending on the region of the body undergoing
treatment. In addition, we used small stainless needles (0.2 X 13 mm)
for auricular acupuncture. 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 patients in the control group also
remained lying still for 25 minutes after embryo transfer. All treatments
remained lying still for 25 minutes after embryo transfer. All treatments
were performed by the same well-trained examiner, in the same way.
The primary point of the study was to determine whether acupuncture
improves the clinical pregnancy rate after IVF or ICSI treatment.
Student's t-test was used as a corrective against any possible
imbalance between the two groups regarding the following variables:
age of patient, number of previous cycles, number of transferred
embryos, endometrial thickness, plasma estradiol on day of transfer,
method of treatment (IVF or ICSI), and blood flow impedance in the
uterine arteries (pulsatility index). Chi-square test was used to
compare the two groups. All statistical analyses were carried out using
the software package Statgraphics (Manugistics, Inc., Rockville, MD).
Results
A total of 160 patients was recruited for the study. Patients who failed
to conceive during the first treatment cycle were not reentered into the
study. According to the randomization, 80 patients were treated with
acupuncture, and 80 patients underwent the usual therapy without
acupuncture.
There were no statistically significant differences
between the two groups with respect to the following covariants: age
of patient, number of previous cycles, number of transferred embryos,
endometrial thickness, plasma estradiol on day of transfer, or method
of treatment (IVF or ICSI). Clinical indications for ART were the same
for patients of both groups. The blood flow impedance in the uterine
arteries (pulsatility index) did not differ between the groups before and
after embryo transfer.
The analysis shows that the pregnancy rate for the acupuncture group
is considerably higher than for the control group (42.5% vs 26.3%;
P=.03).
Discussion
The acupuncture points used in this study were chosen according to
the principles of TCM (10): Stimulation of Taiying meridians (spleen)
and Yangming meridians (stomach, colon) would result in better blood
perfusion and more energy in the uterus. Stimulation of the body
points Cx6, Liv3, and Gv20, as well as stimulation of the ear points 34
and 55, would sedate the patient. Ear point 58 would influence the
uterus, whereas ear point 22 would stabilize the endocrine system.
The anesthesia-like effects of acupuncture have been studied
extensively. Acupuncture needles stimulate muscle afferents
innervating ergoreceptors, which leads to increased ß-endorphin
concentration in the cerebrospinal fluid (11). The hypothalamic ß-
endorphinergic system has inhibitory effects on the vasomotor center,
thereby reducing sympathetic activity. This central mechanism, which
thereby reducing sympathetic activity. This central mechanism, which
involves the hypothalamic and brainstem systems, controls many
major organ systems in the body (12). In addition to central
sympathetic inhibition by the endorphin system, acupuncture
stimulation of the sensory nerve fibers may inhibit the sympathetic
outflow at the spinal level. By changing the concentration of central
opioids, acupuncture may also regulate the function of the
hypothalamic-pituitary-ovarian axis via the central sympathetic system
(13).
Kim et al. (14) suggested that Li4 acupuncture treatment could be
useful in inhibiting the uterus motility. In their rat experiments,
treatment on the Li4 acupoint suppressed the expression of COX-2
enzyme in the endometrium and myometrium of pregnant and
nonpregnant uteri.
Stener-Victorin et al. (3) reduced high uterine artery blood flow
impedance by a series of eight electroacupuncture treatments, twice a
week for 4 weeks. They suggest that a decreased tonic activity in the
sympathetic vasoconstrictor fibers to the uterus and an involvement of
central mechanisms with general inhibition of the sympathetic outflow
may be responsible for this effect. In our study, we could not see any
differences in the pulsatility index between the acupuncture and
control group before or after embryo transfer. This may be due to a
different acupuncture protocol and the selected sample of patients
with high blood flow impedance of the uterine arteries (PI
Stener-Victorin et al. study.
As we could not observe any significant differences in covariants
between the acupuncture and control groups, the results demonstrate
that acupuncture therapy improves pregnancy rate.
Further research is needed to demonstrate precisely how acupuncture
causes physiologic changes in the uterus and the reproductive
system. To rule out the possibility that acupuncture produces only
psychological or psychosomatic effects, we plan to use a placebo
needle set as a control in a future study.
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