Acupuncture for Unexplained Subfertiliy

Study Overview
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Brief Summary
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Infertility affects one in six couples. In a quarter of them, routine tests of semen quality, ovulation or tubal patency fail to reveal any abnormalities and the cause of infertility is unexplained. Acupuncture is being increasingly used by couples with all types of infertility and initial trials have suggested that it could be potentially beneficial in some cases. A number of systematic reviews of acupuncture in IVF have shown conflicting results, but there is no evidence to inform best practice in unexplained infertility. In addition, as an intervention, acupuncture is not cost neutral as it involves multiple visits for treatment sessions delivered by a skilled practitioner. Thus, while acupuncture could have the potential to increase live birth rates in women with unexplained infertility, the clinical and cost effectiveness of acupuncture needs to be confirmed in the context of a large randomized controlled trial.

Official Title
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A Randomized Controlled Trial of Acupuncture Versus Expectant Management in Women With Unexplained Infertility

Conditions
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Unexplained Infertility

Intervention / Treatment
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* Other: Acupuncture
* Other: expectant management


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Women aged 18-40 years Bilateral patent tubes demonstrated by hysterosalpingogram, hysterosalpingo-contrast sonography or laparoscopy Regular menses 21 to 35 days Normal semen parameters :Total motile sperm count ≥10 million. (World Health Organization criteria, 2010) Exclusion criteria Unwillingness to accept either of the two interventions Contra-indications to acupuncture: pacemaker use or bleeding disorder Received acupuncture before 2 months for other diseases which are not related to unexplained infertility. Previously received acupuncture for unexplained infertility Use of hormonal or other medication (including Chinese Herbal prescriptions) which may affect the outcome in the past 2 months. Patients who anticipate taking longer than a one month break from treatment during the trial (i.e. 4 months from randomization).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture plus expectant management<br> | Other: Acupuncture<br>* semi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms<br>Other: expectant management<br>* one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization.<br>|
| Active Comparator: expectant management<br> | Other: expectant management<br>* one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate |  | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate |  | Up to 14 months | 
| Miscarriage rate |  | Up to 14 months | 
| Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. |  | Up to 14 months | 
| quality of life |  | Up to 14 months | 
| Side effect |  | Up to 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unexplained infertility, Acupuncture