OBJECTIVE: To develop a protocol that could be used in future studies to evaluate whether acupuncture improves pregnancy and delivery rates in patients undergoing IVF. DESIGN: Randomized, sham treatment controlled pilot study.

MATERIALS AND METHODS: Patients planning to undergo IVF who meet inclusion/exclusion criteria (age 40 years old at start of stimulation, highest basal FSH 10mIU/mL, 3 prior failed IVF attempts, acupuncture naıeve) were randomly assigned to an acupuncture treatment group or a sham treatment group.

Treatment sessions occurred before the start of gonadotropin stimulation, the day before the oocyte retrieval, the day before the embryo transfer and the day after the embryo transfer. Acupuncture was performed using manual manipulation at 6 to 10 points depending on the timing of the acupuncture treatment. Sham treated patients had needles placed in non meridian points at a shallow depth. Patients were also given a questionnaire regarding their impressions of acupuncture treatment and were asked to guess their group assignment.

Data was analyzed using chi-squared for dichotomous outcome variables (e.g. clinical pregnancy rate, number of take home babies) and t-tests for continuous outcomes (e.g. age).

RESULTS: Twenty-two IVF cycles (19 patients) were randomized with thirteen patients completing the study (14 cycles). Five cycles were not completed due to poor response to ovarian stimulation (4 in the sham group,one in the real group). Other reasons for incomplete cycles (all in the sham group) included a persistent ovarian cyst, no viable embryos for transfer and personal reasons. The overall cycle cancellation rate was 32% compared to a 22% cycle cancellation rate for non study patients of a similar age treated at this center during a similar time period (p.05).

In the 13 patients analyzed, the mean age was 35 years old (SD4.03). There was no statistical difference between true and sham acupuncture groups with respect to age (Sham: Mean35, SD4.6, Real: Mean34, SD4.6). Additionally, there was no significant difference between groups in highest basal FSH, number of oocytes retrieved, or number of embryos transferred. There was a significantly higher chemical pregnancy rate (80% versus 11.0%) in patients receiving true acupuncture compared to sham acupuncture (p.05). The clinical pregnancy rates and the take home baby rates showed a strong trend towards a higher rate with acupuncture treatment though the difference was not statistically significant (60% real treatment vs. 11% sham treatment, p.05.).

Regarding the questionnaire, only one patient correctly guessed their group assignment (real acupuncture). All patients rated their experience as very positive or positive.

CONCLUSION: It is feasible to conduct a randomized, blinded, sham control trial to study the impact of acupuncture on IVF success rates. Such a protocol is well accepted by patients. Preliminary data shows a statistically significant improvement in the biochemical pregnancy rate with acupuncture treatment. Additionally, acupuncture was associated with a strong trend towards higher clinical pregnancy rates and take home baby rates, though more patients will need to be studied to reach any final conclusions.

Objective: The purpose of this study was to determine if there are benefits of standard acupuncture compared to sham acupuncture as an adjunct to IVF.

Materials and Methods: A randomized, controlled, double-blind, cross over pilot trial was performed using a needle-like device (sham acupuncture) as a control. Approval from GAMC’s Investigational Review Board was acquired. Inclusion criteria were women aged 18 to 42 years with a history of failed IVF cycle(s); the presence of both ovaries; and a normal uterine cavity. Exclusion criteria was Kruger morphology <4%.

Results: Seventeen subjects were enrolled and seven subjects completed both arms of the study. The mean age was 36.2 years (range 28-41 years). The mean Day 3 FSH=3 D6.8 IU (range 3-13 IU). There were four ongoing pregnancies after the first cycle, equally distributed. Seven subjects were crossed over after the first cycle. Of these, four from the standard acupuncture group and one from the sham acupuncture group attained pregnancy. Two subjects of the standard acupuncture group were on-going pregnancies and one from the sham group. Only the sham group had two IVF cancellations. An unpaired Mann-Whitney Test using a two-sided p value was performed.

Conclusions: Our study shows a significantly lower amount of gonadotropins used when IVF is combined with standard acupuncture. A 70% pregnancy rate was also achieved with standard acupuncture and IVF, compared to 25%. Larger prospective trials are necessary.

BACKGROUND: Acupuncture has been used during IVF treatment as it may improve outcome, however, there are concerns about the true efficacy of this approach. This randomized double blind study aimed to compare real acupuncture with placebo acupuncture in patients undergoing IVF treatment.

METHODS: On the day of embryo transfer (ET), 370 patients were randomly allocated to either real or placebo acupuncture according to a computer-generated randomization list in sealed opaque envelopes. They received 25 min of real or placebo acupuncture before and after ET. The endometrial and subendometrial vascularity, serum cortisol concentration and the anxiety level were evaluated before and after real and placebo acupuncture. RESULTS: The overall pregnancy rate was significantly higher in the placebo acupuncture group than that in the real acupuncture group (55.1 versus 43.8%, respectively, P 5 0.038; Common odds ratio 1.578 95% confidence interval 1.047–2.378). No significant differences were found in rates of ongoing pregnancy and live birth between the two groups. Reduction of endometrial and subendometrial vascularity, serum cortisol concentration and the anxiety level were observed following both real and placebo acupuncture, although there were no significant differences in the changes in all these indices between the two groups.

CONCLUSIONS: Placebo acupuncture was associated with a significantly higher overall pregnancy rate when compared with real acupuncture. Placebo acupuncture may not be inert.

Objective
To observe the effect and mechanism of acupuncture on infertility of rats with polycystic ovarian syndrome (PCOS).

Methods
PCOS rat model was induced by subcutaneous injection of oil solution of dehydroepiandrosterone (DHEA) in immature (24-day-old) female rats for continuous 20 days. Rats in the control group were given the same dose of DHEA oil.
PCOS rats were randomly divided into the control group (untreated) and the acupuncture group treated by needling acupoints of Guanyuan (CV4), Zhongji (CV3), Sanyinjiao (SP6) and Zigong (CX-CA1), 15 min once a day for 5 continuous days, starting from the 80th day after birth.
All rats were sacrificed at termination of the treatment, their uterus and ovaries were dissected for observation and blood levels of sex hormones were measured.

Results
Compared with the control group, the number of implanted blastocysts and the blastocyst implantation rate were higher and the blood levels of testosterone (T) and estradiol (E2) were lower in the acupuncture group (P<0.05); but the difference between groups in serum levels of follicular stimulating hormone, luteinzing hormone and progesterone were of statistical insignificance (P>0.05).

Moreover, the wet weight of the ovaries was lower and the equipotent diameter and area of glandular organ and cavity area ratio of gland and the stroma and mean thickness of endometria were higher in the acupuncture group than those in the control group (P<0.05).

Conclusion
Acupuncture can significantly down-regulate the expressions of serum levels of T and E2, improve the development of ovaries and uterus, promote ovulation, enhance endometrial receptivity, and advance blastocyst implantation.

Objective: To determine whether changes in serum cortisol (CORT) and PRL are affected by acupuncture (Ac) in Ac-treated IVF patients.

Design: Prospective cohort clinical study.

Setting: Private practice reproductive endocrinology and infertility clinic and private practice acupuncture consortium.
Patient(s): Sixty-seven reproductive-age infertile women undergoing IVF.

Intervention(s): Blood samples were obtained from all consenting new infertility patients and serum CORT and serum PRL were obtained prospectively. Patients were grouped as controls (IVF with no Ac) and treated (IVF with Ac) according to acupuncture protocols derived from randomized controlled trials.

Main Outcome Measure(s): Serum levels of CORT and PRL were measured and synchronized with medication stimulation days of the IVF cycle (e.g., day 2 of stimulation, day 3, etc.). Reproductive outcomes were collected according to Society for Assisted Reproductive Technology protocols, and results were compared between controls and those patients treated with Ac.

Result(s): CORT levels in Ac group were significantly higher on IVF medication days 7, 8, 9, 11, 12, and 13 compared with controls. PRL levels in the Ac group were significantly higher on IVF medication days 5, 6, 7, and 8 compared with controls.

Conclusion(s): In this study, there appears to be a beneficial regulation of CORT and PRL in the Ac group during the medication phase of the IVF treatment with a trend toward more normal fertile cycle dynamics. (Fertil Steril 2008; 2008 by American Society for Reproductive Medicine.)

Conclusion: electroacupuncture could decrease serum FSH and LH levels, and increase estrogen levels in women with ovarian deficiency with little to no side-effects.

To investigate the effects of electroacupuncture (EA) on serum FSH, E2, and LH levels, women with primary ovarian insufficiency (POI) were treated with EA once a day, five times a week for the first four weeks and once every other day, three times a week, for the following two months, and then were followed up for three months. Serum E2, FSH, and LH levels were measured at baseline, at the end of treatment, and during followup. A total of 11 women with POI were included in this prospective consecutive case series study. Compared with baseline, patients’ serum E2 increased, FSH decreased, and LH decreased (P = 0.002, 0.001, and 0.002, resp.) after EA treatment, and these effects persisted during followup. With treatment, 10 patients resumed menstruation (10/11, 90.91%), whereas one patient remained amenorrhea. During followup, two patients, including the one with amenorrhea during treatment, reported absence of menstruation. Temporary pain occurred occasionally, and no other adverse events were found during treatment. The results suggest that EA could decrease serum FSH and LH levels and increase serum E2 level in women with POI with little or no side effects; however, further randomized control trials are needed.

Evid Based Complement Alternat Med. 2013;2013:657234. doi: 10.1155/2013/657234. Epub 2013 Feb 28., Zhou K, Jiang J, Wu J, Liu Z. – Department of Acupuncture, Guang An Men Hospital, China Academy of Chinese Medical Sciences, No. 5 Bei Xian Ge Street, Xuan Wu District, Beijing 100053, China ; Department of Physical Therapy, Daemen College, 4380 Main Street, Amherst, NY 14226, USA.http://www.ncbi.nlm.nih.gov/pubmed/23533511