The Effect of Acupuncture on Psychosocial Outcomes for Women Experiencing Infertility: A Pilot Randomized Controlled Trial

Abstract

Objectives:

The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress.

Design:

The study design was a randomized controlled trial of acupuncture compared with a wait-list control.

Setting:

The study was conducted at The University of Western Sydney.

Subjects:

Thirty-two (32) women aged 20–45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study.

Interventions:

Women received six sessions of acupuncture over 8 weeks.

Outcome measures:

The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported.

Results:

At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] −3.75, 95% confidence interval [CI] −7.58 to 0.84, p=0.05), and less relationship concern (MD −3.66, 95% CI −6.80 to −0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI −2.20 to 26.0, p=0.09) and less anxiety (MD −2.54, 95% CI −5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping.

Conclusions:

Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

Introduction

T here are now a greater number of women attempting pregnancy at an older age when they are less fertile,¹ and this has contributed to the increase in the use of assisted reproductive technologies (ART). Women's responses to unsuccessful attempts to achieve a pregnancy include disappointment, frustration, or significant psychologic distress. Emotional responses to infertility have been linked to grief,² depression,³ anxiety, or chronic stress,⁴ which may have effects on the hypothalamic pituitary axis,⁵ and impact negatively on the chances of a successful pregnancy outcome following IVF.⁶

Various types of psychological interventions already exist for individuals struggling with their response to their infertility or subfertility. These interventions focus on specific therapeutic approaches such as psychodynamic–analytic interventions, mind–body-oriented relaxation, cognitive–behavioral therapies, education, and online counseling interventions.⁷ However, although traditional psychological support is available at many IVF clinics, only a minority of couples utilize these services,⁸ as some individuals do not perceive the need for counseling, particularly in the early stages of treatment, and frequently these services are not offered except as a last resort.

There has been increasing interest by women in the use of complementary therapies (CM) alongside infertility treatments. Five (5) studies in particular have reported on the use of CM by men and women while attending for ART.^9

–13 Two (2) qualitative studies undertaken in Australia of women's experiences of using CM to enhance their fertility have highlighted benefits to their general well-being and fertility enhancement. Rayner and colleagues described women's experiences with complementary therapies as being affirming and empowering.¹⁴ Similar themes were reported from a qualitative study examining women's experiences following a course of acupuncture.¹⁵ These study findings suggest that acupuncture may increase confidence, clarity, and well-being, enhance coping and adaptation, and encourage positive emotion and provide social support. Women also reported feeling relaxed, less stressed, and an increased capacity to cope. These benefits can be described as increasing self-efficacy, a term describing “an ability and confidence to engage in particular health-promoting activities, or to harbor attitudes proximal to these behaviors.” Preliminary data also suggest that acupuncture may improve self-efficacy for women experiencing delays with becoming pregnant.¹⁶ In this observational study, a significant increase in infertility self-efficacy (ISE) scores was found after four consecutive acupuncture treatments.

These emerging data indicating that acupuncture may have a role with improving infertility self-efficacy warrant further research. This article reports on the outcomes from a pilot randomized controlled trial. The authors examined the hypothesis that acupuncture compared to a wait-list control would demonstrate improvements in infertility self-efficacy, and reductions in anxiety and infertility-related stress. Women's experience of acupuncture is also reported.

Materials and Methods

Study design

A mixed-methods, randomized controlled trial, comparing acupuncture with a wait-list control, was conducted.

Subjects and setting

The ethics committee of the University of Western Sydney approved the research. The recruitment strategy used a press release, advertisements in local papers, and online forums. Women were eligible to join the study if they were aged 20–45 years, with a diagnosis of infertility and/or a history of unsuccessfully trying to conceive for 12 months or more. Women planning ART were required to enroll in the study 1 month before commencing their first treatment. Exclusion criteria included women currently involved in a professionally led infertility support group or workshop, or planning to use acupuncture in the next 4 months.

Intervention

Following written consent from participants, and the collection of baseline outcome measures and demographic data, women were randomized to acupuncture or the wait-list control. An independent researcher was responsible for the computer-generated randomization schedule, and the allocation of the randomization sequence was concealed using sealed envelopes. The randomized treatment allocation was known only to the acupuncturist administering the study intervention.

The acupuncture diagnosis and treatment combined the five-element style with a diagnostic focus on individual “causative factors,” and the Traditional Chinese Medicine (TCM) style with diagnosis primarily based on syndrome patterns.¹⁷ Both styles of acupuncture are based on traditional acupuncture theory. TCM is widely practiced in Australia, and a five-element style is practiced among some United Kingdom–trained acupuncturists, and Australian-trained acupuncturists undertaking postprimary qualification training. The acupuncture needling and treatment parameters were based on the findings from an initial study undertaken in clinical practice,¹⁶ and acupuncture points selected in response to emotional complaints.¹⁸ The specific points for each individual were defined at each treatment session, depending on the participant's feedback and needs in relation to their stress. Each treatment followed an individualized protocol addressing the Causative Factor, and TCM diagnosis. Common points used included the Kidney Chest points and points, Neiguan (PC6), Jiansi (PC5), Tongli (HT5), and Shenmen (HT7).

Six (6) acupuncture treatments were performed over 8 weeks, commencing with weekly treatments, and subsequent tapering in the second month. An average of 6.8 needles were administered per participant (range 3–11) (insertions were reduced for the 4 women diagnosed with a pregnancy during the study). The research practitioner (CS) undertook the treatment consultation at the start of each session, she administered the needling, and left the room for a short period midway through the treatment while the participant lay quietly. Treatment sessions lasted 45 minutes, with mostly bilateral needle retention over 20–30 minutes for evens techniques, and dependent on pulse change response to treatment. Needles were withdrawn immediately for tonification. Seirin 0.2-×30-mm acupuncture needles were used. Needle stimulation was administered until de qi was obtained and detected by a needle grasp, or reporting of a needle sensation by the participant (tingling, warmth). The depth of the needle insertion varied with the thickness of skin and fatty tissue at the site of the acupuncture points.¹⁹ A proportional method of point location was used (ACI locator). Moxa, cupping, and herbs were not used, relaxation advice was provided with a focus on using the breath to achieve a relaxation response.

A qualified United Kingdom–trained and licensed acupuncturist (CS) registered with the Australian Acupuncture and Chinese Medicine Association, and with 14 years clinical experience of women's health, was responsible for administering acupuncture. Due to the limited financial resources available to this pilot study, a study investigator (CS) undertook this role.

Women who were randomized to the wait-list control condition completed all assessments but did not receive any active intervention during the 2-month trial. They were offered acupuncture after this time period. The decision to use a wait-list design was based on a lack of previous research in this area, and to systematically examine and build on the evidence from the authors' two earlier studies. The first priority was to establish whether there was evidence of some benefit from acupuncture in a controlled setting.^15,16

Instruments

Primary endpoints were measured at baseline and at 8 weeks following completion of the intervention. Outcome measures included the Fertility Problem Inventory (FPI),²⁰ the Infertility Self-Efficacy Scale²¹ (ISE), and the State–Trait Anxiety Inventory (STAI).²² The FPI is a 46-item validated questionnaire that assesses infertility-related stress, and shows good reliability and validity. Scores are summated into five domains: social concern, sexual concern, relationship concern, rejection of childfree lifestyle, and need for parenthood. The shortened 10-item version of the 20-item STAI was used to measure state anxiety. The STAI has good psychometric properties and has been used extensively in evaluation research. The ISE is a self-report questionnaire consisting of 16 items that probe into the respondents' perceptions about their ability to deal with various aspects of fertility treatment. The ISE has been specifically validated with infertility patients and has demonstrated excellent reliability.

The sample size was based on prior analyses.¹⁶ It was estimated that a moderate to strong effect size would be obtained (i.e., Cohen η=0.7) from acupuncture on the outcomes. With α set at 0.05, and power at 0.8 (80% chance that the expected effect size would be significant), a minimum sample of 32 participants was required (N=16 per group).

The analyses used an intention-to-treat approach, and the initial analysis examined the reproductive, demographic, and baseline characteristics of women randomized to the trial. For differences between groups and over time, analysis of covariance testing difference was undertaken between post-treatment scores on the relevant outcome variable while controlling for pretreatment scores, controlling for previous use of acupuncture. Levels of significance were reported at p<0.05. A study statistician performed the analysis blind to study group.

Qualitative data

Funding received for the pilot study allowed for 10 in-depth interviews. A sample size was expected to produce thematic saturation, with no additional information forthcoming in successive interviews.²³ Women were consecutively invited to participate in the interviews following the completion of their 8-week acupuncture intervention. Two (2) women declined, and invitations were made until the tenth interview had been completed. Interviews were conducted by BC, a junior researcher with the Research Centre. BC received training with conducting in-depth interviews and data analysis from JU and JP, who are researchers experienced in qualitative data collection and analysis. Interviews typically explored the women's experience of infertility, its psychologic impact, and the perceived impact of acupuncture on cognitive control. Women were first asked an open-ended question about their fertility treatment and how it affects them, with prompt questions including reasons for joining the trial, previous experience of fertility treatment, and expectations of treatment. They were then asked about their sessions with the acupuncturist, including what happened, how they felt, whether it made them feel differently, and whether their feelings about it changed over time. Finally, women were asked about the effects of acupuncture, including problems and difficulties and feelings for the future.

Interview data were digitally recorded and transcribed verbatim by a professional transcriber. Transcripts of the interviews were de-identified and checked for transcription accuracy. Three (3) researchers (BC, JU, and JP) read the transcripts independently and subjected the data to a process of coding and thematic analysis, based on notions of consistency, commonality, and the function and effects of specific themes, following established protocols for thematic analysis.²⁴ The research was largely inductive, where the concepts and categories came from the data, rather than being deductive or informed by existing preconceptions about acupuncture and fertility.²⁵ To begin, the data were subject to “open coding,” involving a close reading of each transcript to identify “first-order concepts,” such as “relationship conflict,” “anger,” “love,” “anxiety,” or “increased responsibility” segment by segment.²⁶ “Axial coding” was employed to develop “categories” that subsumed many of the first-order concepts, including “expectations of acupuncture: invoking change,” positive experiences of acupuncture, and “changes achieved after acupuncture.” In the final stage of “selective” coding, a core category of “Expectations and psychologic experiences of acupuncture” was developed, which essentially linked all of the concepts and categories.

Results

Recruitment and baseline data

Women were recruited to the trial between April and September 2009. Promotion of the study led to 124 women making contact with the study center (Fig. 1). All women in the acupuncture group received a minimum of six treatments. One (1) woman withdrew from the wait-list control following allocation to this group. Outcome data were available from 30 women randomized to the study.

FIG. 1.

Recruitment and participant flow through the trial.

Baseline data of participants at trial entry is presented in Table 1. Most women were in their mid-30s, had been trying for a baby for the previous 3 years, employed, and had completed high school education. Women presented with mild to moderate levels of anxiety, moderate levels of self-efficacy, and infertility-related stress. The randomized groups were comparable on most baseline characteristics except for greater previous use of acupuncture in the acupuncture group (56% versus 25%). This was controlled for in the analysis of primary outcomes.

Table 1.

Baseline Characteristics of Participants

	Acupuncture (n=16) Mean SD	Control (n=16) Mean SD
Age	35.1 (4.2)	34.1 (5.2)
BMI	21.6 (14.2)	25.7 (7.9)
Parity 0	68.8	75.0
Duration of infertility	4.50 (3.5)	3.57 (2.4)
Reason for infertility (%)
Male factor	6.3	18.8
Female factor	43.8	18.8
Unexplained	25.0	46.8
Unknown (not investigated)	25.0	18.8
Number of IVF cycles	1.38 (1.7)	1.13 (1.9)
Fertility Problem Inventory
Social concern	29.4 (8.7)	26.4 (8.0)
Sexual concern	23.9 (6.6)	21.1 (8.0)
Relationship concern	23.9 (6.7)	22.9 (4.7)
Rejection of childfree lifestyle	26.3 (6.7)	26.4 (5.2)
Need for parenthood	35.5 (7.2)	33.4 (7.2)
Infertility self-efficacy	75.3 (20.2)	73.5 (22.1)
Stait–Trait Anxiety	20.4 (6.3)	20.4 (5.7)
Previous use of acupuncture (% yes)	56.3	25.0
Ever sought psychologic support services before re: infertility (% yes)	12.5	18.8
Previous use CM as psychosocial support (% yes)	37.5	31.3
Current CM use re: psychosocial support (% yes)	25.0	31.3
Employment status
Full time	68.8	62.5
Part time	18.8	18.8
Home duties	12.5	12.5
Student	0.0	6.3
Education
Finish high school (% yes)	100	87.5
Tertiary education (% yes)	87.5	87.5
University (% yes)	56.3	31.3
Race
White	93.8	100
Other	6.3	0.0
Marital situation
Single	0.0	6.3
Married/de facto	100	93.8

SD, standard deviation; BMI, body–mass index; IVF, in vitro fertilization; CM, complementary therapies.

Outcome data

Adjusted analyses are presented in Table 2. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the FPI, with less social concern defined as sensitivity to comments, reminders of infertility, feelings of social isolation, and alienation from family or peers (MD −3.75, 95% CI −7.58 to 0.84, p=0.05). Women receiving acupuncture also reported significantly less relationship concern, defined as difficulty talking about infertility, understanding/accepting sex differences, and concerns about the impact infertility on their relationship (MD −3.66, 95% CI −6.80 to −0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI −2.20 to 26.0, p=0.09) and less anxiety (MD −2.54, 95% CI −5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control.

Table 2.

Primary and Secondary Endpoints by Group

	Acupuncture (n=16)	Control (n=14)	MD	95% CI	p
STAI	18.1 (1.1)	20.7 (1.2)	−2.54	(−5.95 to 0.86)	0.083
Fertility problem inventory
Social concern	24.8 (1.2)	28.6 (1.3)	−3.75	(−7.58 to 0.84)	0.055
Sexual concern	20.3 (1.2)	22.8 (1.3)	−2.50	(−6.32 to 1.32)	0.190
Relationship concern	22.1 (1.0)	25.8 (1.1)	−3.66	(−6.80 to −0.052)	0.024
Rejection of childfree lifestyle	24.9 (1.0)	24.9 (1.1)	−0.26	(−3.14 to 3.09)	0.987
Need for parenthood	32.5 (1.3)	33.9 (1.4)	−1.38	(−5.47 to 2.71)	0.495
Infertility self- efficacy	85.9 (4.6)	74.0 (4.9)	11.9	(−2.20 to 26.0)	0.095

Raw data n, %, or mean standard error and effect size with 95% CI.

MD, mean difference; CI, confidence interval; STAI, State–Trait Anxiety Inventory.

Qualitative analysis

Expectations and psychological experiences of acupuncture

The mean age of women participating in the interviews was 36 years, the duration of their infertility was 5.2 years, 50% had used acupuncture previously, and 4 women had a diagnosis of unexplained infertility. Women's responses are organized under three themes: “expectations of acupuncture: invoking change,” “positive experiences of acupuncture,” and “changes achieved after acupuncture.”

Expectations of acupuncture: Invoking change

A number of women initially spoke of having few or unclear expectations, but as having an open mind about acupuncture.

I was fairly open-minded about it. I've never had acupuncture ever before, so I had no expectations of what it would be like. (S5)

This participant also said that acupuncture provided a sense of purpose: “At least it feels as though you're doing something.” Several women spoke about their expectation that participation in the trial would provide an opportunity to regain some control of their fertility, and a perceived need to try something new. Many women came to the trial at a point of despair with lack of success in achieving a pregnancy, but also an awareness that their fertility was declining with increasing age. “It was starting to get really desperate” (S1), and for the older women “I turned 41 and I thought, I'm running out of time” (S1). For women who expressed a sense of their options running out, the trial was seen as an opportunity for change.

I just thought it would be a good opportunity just to look into another avenue of trying to find out, or trying to help me in order to probably—not solve my fertility problems, because I think I'm asking for a miracle there—just help guide me a bit as to what my next step might've been and where do I go from here. (S10)

An opportunity to try something new was also associated with an expectation that acupuncture carried little risk.

I thought, yeah, like I fit the criteria very well and it definitely won't hurt to just to do it, like I could get benefit out of it and even if I don't, nothing bad will happen, so it's worth it to have a go. (S3)

Some women expressed hopefulness but not expectation that this change would help them to become pregnant.

Well, I mean there was always a hope that I'd get pregnant somewhere along the line, but no, not really, like I didn't really have any too great expectations about it. (S2)

For others, acupuncture invoked expectations that the trial would assist with achieving relaxation.

I think I thought it would be more physical stress relief rather than anything emotional. I just really didn't know what to expect, so I thought it would be a relaxation thing, kind of like getting a massage for an hour but it would be acupuncture. (S4)

Positive experiences of acupuncture

All 10 women described the experience of the acupuncture sessions as positive. The positive effects of acupuncture were related to a sense of relaxation and time out, engagement with the practitioner, and an intervention that had very few negative side-effects.

Nine (9) women reported that they found the acupuncture relaxing during the session, that it had immediate benefits, and that the effects were sustained.

It was half an hour of nothing. Not having to think about it, half an hour of just lying there and having nothing, if that makes any sense. (S4)

It was a real chance to switch off for a change. I remember when I left the first session, I walked out feeling lighter, feeling less stressed, feeling really positive for a change. (S4)

Women also described positive physical sensations from acupuncture. I remember getting outside and I felt a bit buzzy and I thought, jeez, I don't know if I'm actually relaxed or I'm actually—like she's obviously got it so the blood's racing around my body; does that mean I'm relaxed? (S9).

I had a sense of warmth and it lasted for like 1 week. (S3)

Well it was a very warm fuzzy feeling…very relaxed, warm, and feeling like it had made a big difference. (S5)

Half of the women described a positive surprise with the level of engagement they experienced with the research acupuncturist, in particular with the trust invoked in the therapeutic relationship, as this was occurring with someone new and disconnected from mainstream services.

It was just somebody outside of everyone else who was poking or prodding me, or friends and family that were asking questions and not understanding it. (S4)

I found her really easy to talk to in that regard, so that was good. What I found really positive was talking to [her]…before the treatment; that was really great. (S2)

I think there is a benefit in having someone to talk to as well as the actual acupuncture. It was an unexpected opportunity to talk to someone about the situation who you knew was going to be private. (S5)

Five (5) women mentioned some negative side-effects such as minor pain, or feeling light headed after the treatment. For example, one woman said “Sometimes you would get a point that was sore” (S3). “I don't know if pain is the right word, or just strange” (S4). However, no women indicated that the risks outweighed the benefits from acupuncture.

Changes achieved after acupuncture

Several different impacts of acupuncture were described, with the effects commencing soon after the treatment and being sustained. The majority of women described a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Over the course of the intervention, several women spoke of a change in their focus toward pregnancy, coping, a reduction in anxiety, a change in attitude, and a change in communication with others.

It just took a lot of the anxiety off, the anxiety of what if I don't, what if I can't, what if I'm too old. That sort of panic was left.…Each visit that got less and less, which is a good thing. (S1)

Whereas now I do care (about getting pregnant), but there is a limit to how much I am willing to do for it. Now I can just see things, yeah, a bit more clearly and in a bit more balanced way, which is good.…I am just going to live my life and do what I do.…Now I want to have a happy life inside myself. (S3)

Some women also attributed improved relationships with their partner to the intervention.

It's opened up communication between myself and my husband, a big thing between us. I think that was one of the most positive things to come out of me agreeing to be [in the study] in the first place.…By taking part, yeah, it has opened up communication between us so that together we're resolved that, okay, well we will start trying a bit more fervently than before. (S2)

The women's comments reflected a change in their sense of control and a changed perspective and clarity.

I think at the beginning of the trial I was probably more focused on, oh yeah, like I just want to get pregnant and this study might help me and then I am going to do IVF. Whereas now I do care, but there is a limit to how much I am willing to do for it. I am just focusing on some other things because it is very time consuming, and I have wasted a lot of time and energy thinking about it and you don't want your whole life to be about one topic. (S3)

For other women, the treatment had a positive benefit as they prepared for a future IVF cycle, providing an opportunity to relax, and some time out for themselves.

I think the acupuncture gave me time in the lead up to [IVF] it, just to physically relax and physically sort of shut down. (S4)

For most women, however, acupuncture was associated with a general feeling of positivity, regeneration, and improved well-being.

I guess the best way I could put it is that I left here in a positive frame of mind. Apart from being relaxed and calm throughout it all, when I walked out that door, I thought to myself, you know—I felt good. I felt good and I felt that whatever I was getting from the actual acupuncture session lasted more than just that hour that I was here. (S10)

Discussion

This study provides preliminary data suggesting that acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. The data also show promising trends in relation to improved self-efficacy and reduced anxiety. These outcomes were complemented by findings from the in-depth interviews that highlighted a changed perception for women with regard to coping, feeling less anxious, feeling physically calm, relaxed, and overall having achieved a greater sense of well-being. To the authors' knowledge, this is the first controlled clinical trial to examine the effects from acupuncture on psychologic outcomes for women experiencing infertility. The study also demonstrated feasibility with timely recruitment, the use of appropriate outcome measures, acceptability, and compliance with the acupuncture.

Women's experiences of the intervention highlighted their surprise at the engagement with the study practitioner. The development of a therapeutic relationship between the participant and practitioner is acknowledged as an important part of the acupuncture in clinical practice. Kelley and colleagues have suggested that such interaction can reduce stress and increase expectancies for improvement.²⁷ The aim of this research was not to explore efficacy of how and why acupuncture may have worked in this setting. However, women's responses from the interviews highlight the importance of practitioner factors, and these may have contributed to some women's positive experience. The authors acknowledge the experience of CS working with this client group, or she may have been highly motivated to developing a strong therapeutic alliance. This requires further study within a larger resourced study with additional study practitioners, and collection of data describing practitioner characteristics.

Some women spoke of a changed perspective toward the urgency to achieve a pregnancy using assisted fertility. This finding has clinical implications for the older woman's potential fertility, and highlights a need for the acupuncturist to encourage the women to discuss her treatment plans with her specialist. It is unclear how applicable this finding is to a wider population of women using acupuncture to reduce infertility-related stress, and this finding warrants further exploration in future research.

The pilot study has several strengths. The trial was randomized, thereby reducing selection bias. Second, the fertility profile of women participating in the study includes a cohort of women with subfertility, not of all whom may have sought fertility investigation and treatment. This may reflect one group of women using acupuncture. However, it is also possible that this group of women with unknown fertility issues may be less emotionally or psychologically affected than women who have or are seeking fertility treatment. However, the baseline fertility-related stress scores (using the FPI) of our population are similar to the baseline FPI scores of 190 women undergoing treatment at three fertility centers in the United States²⁸ suggesting similar levels of stress, although women in the current study may have slightly greater coping skills. This study's findings are also consistent with the authors' earlier observational and qualitative research suggesting improvements from acupuncture with self-efficacy and resilience,^15,16 with data from both studies showing similar mean post-treatment scores of 83.3 and 85.9. The similarity of scores from different geographical and socioeconomic study populations increases the generalizability of the findings to a wider population. Although the study was of a short duration, encouraging improvements in self-efficacy and anxiety were observed, and inclusion of interviews provided data that supported the quantitative findings from the trial. Altogether, this study demonstrated real, tangible, and most importantly, positive physical and emotional effects following acupuncture.

The study does have some limitations. First, the pilot results should be interpreted with caution due to the small sample size and the lack of participant blinding. The authors demonstrated statistical differences on two domains of the FPI and trends toward significance on the STAI and ISE scales. This effect was smaller than the clinical observational study. However, the findings from the qualitative study suggest that the effects from acupuncture were clinically significant to women. Although the number of study participants participating in the qualitative study was small, it was able to provide a preliminary understanding of the subjective experiences of the acupuncture. It was also possible that the outcomes from acupuncture may differ according to women's duration of infertility or subfertility. This study was too small to examine this. Future research should use a larger sample, and a follow-up assessment to see whether changes and positive perceptions of acupuncture are maintained over time. Second, the study question and design aimed to evaluate the effect of acupuncture used in clinical practice, but the design used did not aim to control for other confounders such as the therapeutic relationship, the role of patient expectations, or practitioner intent. Third, it is possible that the dose of acupuncture was inadequate; for example, more frequent treatments, or using a team of acupuncture researchers, or a different treatment protocol may have generated different results. Fourth, women's expectations or thoughts about what might happen as a result of treatment may have differed following group allocation by randomization, and these expectations may have influenced treatment outcomes. The influence of expectations on the current study outcomes is unclear, although interview data suggest that women expressing expectations were mostly unrelated to the experiences and impacts as reported by women. A positive effect on treatment outcome from self-initiated help-seeking behavior on outcomes has been demonstrated in one study with a population of women receiving IVF.²⁹ To address some of these limitations, an appropriately powered study examining treatment effectiveness is now planned. A trial using mixed methods with qualitative methods used to explore participant's expectations, and practitioner factors in both groups at various stages of the study may contribute to increasing our understanding of the contribution of expectancy and treatment outcomes.

Conclusions

Psychologic interventions providing patient preparation and psychologic support for infertile patients have been shown to produce beneficial outcomes including a reduction in distress.^30,31 While women seek out acupuncturists to provide fertility support, acupuncture may provide an opportunity for adjunctive support to women struggling with their infertility. The current findings suggest a need for further research; evaluating the role of acupuncture is now feasible and justified.

Footnotes

Acknowledgments

The authors thank Ben Colagiuri for statistical support. This study was funded by a research grant from the University of Western Sydney.

Clinical Trial Registration: Australian New Zealand Clinical Trials Registry, www.anzctr.org.au ACTRN ACTRN12609000288224.

Disclosure Statement

No competing financial interests exist.

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